#set in the present timeline of qc

[apinchofm]

Mistaken Identity

Edwina visiting St James' for tea with the Queen leads her to another encounter with King George.

set during QC: ABS

[hamletshoeratio]

didnt she also say something nasty about the queen when one of her kids had just died

Yeah here's part 2 of this

The way she talked about the death of Queen Charlotte's granddaughter; Princess Charlotte, who was historically only twenty-one when she died in childbirth. The Lady Whistledown commentary in QC is just outright cruel, it's clear Queen Charlotte in the off-season (QC present day timeline being set in the Winter/Early spring break between season 2 & 3) becomes Penelope's biggest target in the aftermath of her fallout with Eloise. There's no other way to describe it.

Ngl the above is really disturbing to me. She's angry at Eloise, has lost access to info from the Bridgertons because of her falling out with Eloise, and she's angry at the Queen for getting angry at Penelope's own words as LW, and trying to discover LW as a result. And so she spends the off-season insulting and attacking a grieving Queen Charlotte. I mean that's one way for a flower to bloom I guess...

Theo, one of the only working class characters in the show, nearly lost his job because of lady whistledown and may have lost it in the aftermath of the season.

A lot of her general commentary as Lady Whistledown isn't clever or witty; it's just outright cruel.

The way she talks about the Bridgerton family, a family that trusts and cares for her, is horrible. Particularly, the way she wrote about Daphne in season 1.

Betraying Eloise's trust for two entire seasons because it didn't start with the Theo situation. She listened to Eloise's frustrations about Daphne and then used LW to attack and belittle Daphne. Speaking as a sibling, I will rant about my sisters until kingdom come to my friends but the minute a so-called friend starts publicly attacking my sister, it's over. I would not be in control of my actions. Like over the course of two seasons, she's attacked and nearly destroyed the reputations of Eloise's eldest sister, two of her brothers, her first love, and the entire family as a result. Judging by the Bridgertons were born to shine line in the trailer, I doubt Francesca will make it through the season unscathed.

She hasn't felt real remorse. Despite nearly causing Marina's death (as she tried to miscarry in the aftermath of LW revealing her pregnancy), she ends season 1 smirking about being LW. Hasn't written or contacted Marina to see how she has been since, got jealous Colin went to see her and still probably hasn't written or visited her. Not to mention her "I least did something. All you did is talk" speech at the end of season 2 to Eloise. A speech that wasn't even accurate as Eloise had been to meetings, listened to speeches and debates, debated with Theo, shared and read and discussed different political leaflets with Theo, Eloise had grown intellectually from the beginning to the end of the season. It's because of Penelope that that came to an end.

Outside of rescuing Daphne from her betrothel to Berbrooke in s1, what good has her work as LW actually done? It's ruined far more lives than it's helped, and intervened countless times when it didn't have authority to. Many secrets weren't Penelope's to tell.

I could honestly keep going but I genuinely don't know how she's supposed to get redeemed in eight episodes because the character we have at the minute in no way deserves a happy ending. LW didn't really matter in the books as it wasn't as active a plot point as it is in the show. By expanding the LW concept to give Penelope a more complex arc, they've unwittingly robbed her of what made people like her book counterpart and as a result created a villain that they have no intention of trying to redeem, because they don't believe she needs to be redeemed.

[bridgertonbabe]

Friendly reminder to everyone that the real Queen Charlotte died in Nov. 1818. I was about to say that unless Shonda & Shondaland want to piss off historians, QC should die soon, or at the latest in between seasons 4 & 5 but, who am I kidding 😂 they've already pissed off almost half of the historian sphere & for various different reasons 😂 (one's topic of outrage depends on which area of expertise one has, the only one to beat Bridgerton in historian rage is The Crown)

P.S. How did I miss that her name is actually Sophia Charlotte of Mecklenburg-Strelitz? I knew the Mecklenburg part, I knew she had a daughter named Sophia but... SHE HERSELF IS NAMED SOPHIA

P.S.S. I hate to say it (because it goes against "my brand") but I'm slowly getting around to the idea that my girl Sophie is the illegitimate grandchild of QC...

See my theory is that they moved Polin's season in order to have Queen Charlotte present for the Whistledown story. While QC wasn't present in the books, in the show her main storyline has been her vested interest and obsession with Lady Whistledown and trying to figure out who she is. If the show had followed along the timeline set in the books then by 1824 when Polin get together and Whistledown is revealed QC (historically) would have been long dead and it would make her storylines in the first two seasons essentially null and void. There would be no pay-off to have her absent from a storyline she was involved in and so I personally think that's one of the main reasons Polin's season was moved forward. I also think that's why the Queen Charlotte spin-off was created and capitalised now while she's still present in the main Bridgerton series; to me these decisions were all made because of QC's real life death occurring mid-way through the show's timeline and they're going to adhere to that fact.

[compliancehelp]

How Does a Business Management System Support Construction Companies?

A business management system is a comprehensive model for providing support for how to accomplish various business objectives. For construction companies, it is necessary to fulfill customer demands, maintain the best market practices, and keep a safe and secure working place. An effective management system can help with a plethora of issues within a workplace. From improving the quality of products to risk management or data safety management. These management standards are designed by ISO companies and have comprehensive benefits. The present blog will discuss the type of help a business management standard can provide to construction companies.

Project Management

Project Planning and Scheduling: Define project scope, objectives, and deliverables. Use project management tools to create detailed schedules, allocate resources, and set timelines.

Resource Management: Plan and manage the allocation of resources such as labour, equipment, and materials to ensure efficient use and availability when needed.

Cost Management: Develop and monitor project budgets, track expenses, and ensure that projects are completed within the allocated budget. Implement cost control measures to prevent overruns.

Compliance and Regulatory Management

Regulatory Compliance: Ensure compliance with local, regional, and national regulations, including building codes, environmental regulations, and labour laws.

Permitting and Approvals: Manage the process of obtaining necessary permits and approvals from relevant authorities.

Supply Chain and Procurement Management

Supplier and Subcontractor Management: Evaluate and select suppliers and subcontractors based on their ability to meet project requirements. Manage contracts, monitor performance, and ensure timely delivery of goods and services.

Procurement Processes: Establish procurement processes for the purchase of materials and services. Ensure competitive bidding, cost-effectiveness, and quality.

Financial Management

Accounting and Financial Reporting: Maintain accurate financial records, including income, expenses, and cash flow. Generate financial reports to track the financial health of the business.

Invoicing and Payments: Manage the invoicing process and ensure timely payments from clients. Monitor accounts payable to ensure timely payment to suppliers and subcontractors.

Quality Management

Quality Assurance (QA): Develop and implement quality assurance policies and procedures to ensure that all construction activities meet predefined quality standards and comply with regulatory requirements.

Quality Control (QC): Perform regular inspections and tests at various stages of construction to ensure the quality of materials and workmanship. Document and address any defects or non-conformities.

Supply Chain and Procurement Management

Supplier and Subcontractor Management: Evaluate and select suppliers and subcontractors based on their ability to meet project requirements. Manage contracts, monitor performance, and ensure timely delivery of goods and services.

Procurement Processes: Establish procurement processes for the purchase of materials and services. Ensure competitive bidding, cost-effectiveness, and quality.

Client and Stakeholder Management

Communication: Maintain regular communication with clients and stakeholders to keep them informed about project progress, issues, and changes.

Customer Satisfaction: Implement processes to gather feedback from clients and stakeholders. Address concerns and ensure that their requirements and expectations are met.

Information Technology and Data Management

IT Infrastructure: Implement and maintain IT systems and software to support project management, communication, and data management.

Data Security: Ensure the security of project data and sensitive information. Implement measures to protect against data breaches and cyber threats.

To understand which business management system you must get, you can consider getting consultation from ISO certified agencies. Their consultation is bespoke and comprehensive. You can accomplish 100% compliance without paying hefty fees.

Also Read: Is Having an ISO 14001 Certificate Equivalent to The AS5377 Accreditation?

[nightblood999]

Unique Podcasts:

If you’re looking for something different, try one of these:

 What’s the Frequency

               What’s The Frequency is a psychedelic noir audio drama podcast set in 1940s Los Angeles. Recently radio broadcasts in the city have been reduced to static, leaving a popular radio serial as the only remaining show on the air. Even then the show finds itself continuously interrupted by a mysterious broadcast. A lone distorted voice reaching out for help. Follow Walter “Troubles” Mix and his partner Whitney as they search for a missing writer and navigate through a city quickly falling into madness. Could the mysterious voice be the culprit? Will anyone be able to stop the madness from spreading? And… What’s The Frequency?

Why I love it: This podcast has some of the best and most loveable main characters ever written.

 Alba Salix, Royal Physician

           A witch, her apprentice, and her fairy herbalist treat the ills of a fairy-tale kingdom.

Why I love it: A fantasy podcast that not D&D or based on D&D? What? Also, Its absolutely hilarious once you get over Magnus’s voice.

 Windfall

           Ever since the castle first appeared in the sky above the city of Windfall, its residents have been building upward. Now the city consists of towers where the wealthiest residents live at the top while the poor eke out a living on the ground. Our podcast follows Cas, Shaima, and Argus, three brothers who live with their Uncle Vern after being orphaned during the grounder rebellion twenty years earlier. When Cas’s best friend, Kendall, is offered a position with the Wolfpac, Windfall’s military cult that acts as the city’s police, Cas is forced to decide where his loyalties lie. Meanwhile, something sinister looms over the city itself, threatening the lives of all who live in Windfall, from the wealthiest residents to the ground-level poor.

Why I love it: This is so well written, and so well voiced, and the sound design is amazing, and I don’t understand why it doesn’t have a cult following to be honest.

Time: Bombs

           Created, written, recorded, produced, and released in just one week, Time Bombs is a new audio drama podcast about the hilarious world of bomb disposal. From the team behind the Webby Award nominated sci-fi audio drama Wolf 359, ride along with EOD technician Simon Teller on the busiest night of the year for him and his team - when business is, quite literally, booming.

Why I love it: Its literally the same team that made my favorite podcast ever of course I love it.

 StarTripper!!

           Feston Pyxis, native of the bureaucracy planet Lorvin, has left it all behind! He’s said his goodbyes, he’s sold all his B-movie memorabilia, and he’s bought a Physiclast QCS-25 K-series ship, known to the wise as a “StarTripper.” Together with the onboard assistant PROXY, Feston’s looking for any and every good time there is to be had across the stars!

Why I love it: Its actually happy. There are so many sad podcasts with angst and inetemse emotion and this was something I could just…. Enjoy? With no hurt? Yes!

 Zero Hours:

         Zero Hours is an anthology series, where every story is a different take on the end of the world - or at least something that feels like the end of the world. Each episode is organized around a kind of apocalypse, whether the cataclysm is planetary or personal. The stories are also set in succeeding centuries, with 99-year intervals separating each episode. The show begins in the past, catches up to the present, and eventually overtakes it.

          Some installments are darkly comedic, others grimly contemplative, and others still thrillingly contentious. But they all explore the same question: how do we keep going when the world is crashing down around us? Again and again, issues of survival, trust, and personhood will plague our characters as they attempt to navigate dangerous, changing circumstances and figure out how to avert The End, or at least how to meet it.

Why I love it: This was also made by the team behind Wolf 359, and its such a unique concept.

 Fairy Tales for Unwanted Children

             Imagine if fairy tales were written like episodes of the Twilight Zone. Now imagine listening to them while happy music plays in the background.

Why I love it: I love the Twilight Zone, and nothing really filled that gap after I watched every episode ever produced. But Fairy Tales for unwanted children fills my need for more Grimm’s fairy tales and more twilight zone at the same time!

 Janus Descending

          Janus Descending is a limited series, science fiction/horror audio drama told through single perspective narration. The story follows the arrival of two xenoarcheologists, Peter and Chel,  on a small world orbiting a binary star. But what starts off as an expedition to survey the planet and the remains of a lost alien civilization, turns into a monstrous game of cat and mouse, as the two scientists are left to face the creatures that killed the planet in the first place. Told from alternating perspectives, Janus Descending is an experience of crossing timelines, as Peter describes the nightmare from end to beginning, and Chel, from beginning to the end.

Why I love it: Watching it all come together as Peter slowly works his way backwards through the story, and Chel forwards, was fascinating.

 The Antique Shop

           In desperate need of a job, Maya finds work in an old antique shop owned by a mysterious woman. The more time she spends in the shop the further the real world becomes, and Maya soon begins to realize that nothing is as it seems. 

Why I love it: This is the Genre that just Hits The Spot. It’s like Howls moving castle (Book version) but podcast form and slightly darker. Why is there not a bigger following for this podcast? It deserves a bigger following!

[a-student-out-of-time]

Twisted Sister Arc Review Part 1

Hi guys I’m the Anon who does the reviews around here…guess you could call me the Review Anon? Wonder what the lore behind me would be…anyway that doesn’t matter! Point is, I have an Arc to review and Jesus is this a big one. So big that A) I’m doing submissions (with permission from the Mod of course) and B) I’m splitting the review into 3 parts. Heavy Arcs are Heavy and a LOT of stuff happens here so let’s get right into it!

So, the parts of the Twisted Sister Arc are first the Massacre, second is the Mindwipe and third is the Prison Break. Last one doesn’t start with M but I’m not doing rhyming here, but that’s enough time wasting let’s get right into it~

Massacre

Easily the darkest part of the Arc but given the Arc is basically Kanade being a Slasher Killer here, what do you expect? While Danganronpa is a franchise about murder, and we had serial killers in it both canon and fanon the nature of the Killing Game means that a full-blooded mass killing akin to many slasher films hasn’t really occurred in the franchise before. This makes Kanade’s bloody rampage here even more disturbing, as while we have had mass killings before, see Mukuro’s rampage through Giboua Middle School in Killer Killer, those are established as backstory drops for the characters, we never actually see one being carried out in action. And going back to that massacre, Mukuro only did it because Junko thought her sister’s killer intent might have slipped and it’s to prove to her she is still a killer, but here Kanade is killing for cold blooded revenge. And she doesn’t just kill a bunch of randoms as she brutally murders Iroha, Peko, Akane, Nekomaru, Sonia and Kokoro very brutally and very effectively. I knew something was up given that the entire school went into lockdown and all the fighters from Class 77-B were geared to fight Kanade to the death, and Kanade is such a pansy of a fighter that Sonia beat the living shit out of here, and Syo was taken down by the QC, and we all know how terrifying Syo is. But once the bodies started to drop, I knew that the first time that Hajime would reset on purpose was coming up and there were so many questions. Who set Kanade up for this? Someone had to be helping her…. but who and why? Juu could have let her out but he couldn’t have supplied Kanade with her tools and intel (more on that later) so it has to be someone else.

Within the darkness of this timeline there is of course your heroes. There are those like Peko who got a lucky shot on Kanade which set a chain line of events leading to Kanade’s death, Mikako who made Kanade’s injuries worse and Kokoro who stabbed Kanade in the eye. But those small victories led to total loses as even if Peko didn’t die, she would be crippled for life and moreover she failed to protect her classmates from Kanade’s wrath, and Mikako lost her mother, just as she started to finally connect with her. You may have noticed that I haven’t mentioned two names yet, and that’s because they deserve their own paragraphs, I am of course referring to Nikei and Hibiki.

I’m gonna start with the next person who attacks Kanade and that is of course our Journalist boy here. To say this day has been terrible to him would be a massive understatement as one minute he is suffering an energy crash from downing one too many Red Bulls and having lewd thoughts, to running faster than if he happened to be in Mexico (Seriously, if you happen to be a journalist just don’t go to Mexico) to Hope’s Peak and thanks to Ankle Effects, arriving alongside Hajime to a bloodbath. There’s his constant refusal to accept that Iroha is killed, even though we as the audience knew that given Iroha tried to stop Kanade as soon as she arrived at Hope’s Peak and that Kanade was seen by Sonia and co chopping up security guards, the likelihood of her survival was next to none. This carries on from the conversation Nikei had with Yoruko in the previous Arc where he still believes he is dangerous and that he doesn’t see the other Voids as friends or equals, but rather he took the role as leader because he wanted to have power for once in his life, something he alluded to in the Void Theatre during Chapter 5. However, his reaction to Iroha’s unknown safety, and eventually the truth that Kanade really did butcher the poor painter, proves otherwise. While Nikei’s relationship with his fellow Voids canonically won’t get revealed until LINIQ decides to get around to doing the Onmake mode, in which one of the stories in that is going to be about Void pre Mikado- with someone, most likely Nikei, being the POV character, here the fact his first thoughts upon finding out his ‘little sister’ is dead is to disregard the no-killing rule and just beat Kanade to death, proves that he does care about his fellow Voids, but is in several layers of denial. Out of all the Voids, Nikei is easily the most guarded and paranoid of the lot, and while the others have loosened up around Hajime and co, Nikei still has a lot of inner demons he has to deal with before he could truly open up to the rest of the QC. And Kanade chopping his right hand off, doesn’t help matters though I do give Nikei credit that unlike in the OG timeline, where upon his right hand been blown up by his exploding gun, he just broke down crying, here, he tries to carry on the fight regardless, or he would have had the other person I need to talk about didn’t show up. This is pretty important to establish that while most of the Voids now are pretty far removed from their canon selves and are unlikely to regress back in that, Nikei is still closely tied with his bastard canon self and more work needs to be done for him to detach from that.

But moving on from someone who needs to get some work done, let’s move onto someone who has seen the natural conclusion of their character development, Hibiki! Ever since Hajime and Chiaki rescued Hibiki from her twisted sister (*rim shot*) back in July, she has been making a ton of progress, firstly coming to terms with what Kanade did and her true nature, developing friendly healthy relationships with Class 77-B, the QC and of course a romantic relationship with Hajime. It seemed kind of cliché for Hibiki to fall for Hajime but then again a) Danganronpa can be cliché at times and B) As a Danganronpa Protagonist Hajime cannot turn off his swag. Then there is her officially joining the QC, learning how to fight and being a complete and utter badarse and a caring lover when needed as she confronted Hajime back when he died the second time. We all knew it was only a matter of time when Hibiki had to confront her sister and when Kanade broke into the school, we saw fully, how much Hibiki has grown in the past 3 months. The old Hibiki would have curled up in a corner terrified, crying and probably going into the Puppet State. Here though, Hibiki’s FIRST THOUGHTS upon finding out that Kanade is more dangerous now is to done some armour and get some weapons, and face her sister head on with no hesitation. All without going into the Puppet State at least once, which probably means that its more or less gone now. Kanade tried to talk her sister out of fighting her, but Hikibi isn’t buying Kanade’s insurance anymore and a fight breaks out. If this ever gets animated or becomes a visual novel, I would love to see the Hibiki vs Kanade fight animated as its brilliant, its epic and it’s just so satisfying to see Kanade getting the living snot beaten out of her. You could argue that Nikei’s mauling of Kanade was like that but there, Nikei was more or less in grief due to Iroha’s death and the whole thing was as painful to watch as the final fight in Captain America: Civil War, not saying what because spoilers ahoy. Here though is a glorious battle, as Hibiki gets to deliver justice onto her demonic sister and it is SO SO satisfying, given that a reset happens shortly afterwards.

And sadly, with that, we come to easily the weakest part of not only this part of the arc, but the arc overall, Yasuke’s multiverse theory. It could be written better, and even the Mod agrees that the way it was presented shouldn’t have been the way it worse, that having Umeko throw some ideas at Hajime and him coming to the conclusion that they might have been living in a multiverse be better narrative then Yasuke be like ‘Oh hey I am suddenly an expert on Time Travel now’. It would make Hajime breaking his no kill rule that much more impactful as he doesn’t have the excuses of not only Nikei’s who was currently going through a mental breakdown, and in the current plot where Yasuke more or less planted the seed of doubt in Hajime’s mind. Yasuke still has a role to play in this arc but during the Massacre timeline, I feel like he could have been removed entirely from the plot and not only would it have made no difference, but then most readers wouldn’t be complaining about it as much as Yasuke being a general A-hole wouldn’t tick them off. I’m not saying ‘THIS IS AS BAD AS ONCOMING STORM’ as that Arc was just a giant clusterfuck of a mess, and aside from this one part, the arc is very strong overall, but I will give criticism when due. I’m not mentioning my thoughts on Yasuke as a whole here because he’s more relevant in other parts of the Arc. However, Hajime killing Kanade and himself at the same time is brilliant and seeing Kanade begging for her life as Hajime throws her out of the window is so satisfying given not only all the crap she has been dealing up until that point, but also because in SDAR2, she was 100% fulfilled with the events at that point and given it was HIBIKI who was begging for her life then, let’s just say karma is a bigger bitch then Kanade is.

And that concludes the Massacre part of the Arc as Hajime kills himself and Kanade at the same time and he goes back to just before Nikei started to have indecent thoughts. No time to look at the 3rd page of the national newspapers’ boy, we got a serial killer to stop! And with that I’m stopping here as the Massacre part is finished. But this review is far from over, this is just here because otherwise my, the Mod’s and everyone else’s brains won’t be able to process all of this. Stay tuned for part 2 when we cover Kanade’s capture, a scrum debate among the QC and a bold move by the Mod which I do wish will come up more! Until then, Adios! - Review Anon

//Part 1 of 3

//Finally get to submit these

[divinikey]

the timeline in which they had a person in their life when they needed one the most.

MEME. ; under read more because it became Long.

wherein layla heartfilia lives, lucy has wanderlust, jude heartfilia is a better businessman and everyone is collectively happier.

in this timeline---layla heartfilia has the aquarius key. layla heartfilia survives and the dragons comes through the gate and she has fulfilled her destiny. many heartfilia women knew the tale and since she was a child, this task was of utmost importance. in fact, until she met jude, she did not know if she even wanted to have children: her own mothers and their mothers etc; had burdened every daughter with the task of saving all of humanity through their celestial spirit magic.

but, then she met jude. and the idea of a family became something less burdensome, something that did not have the same connotations as what her own family was. and so: lucy heartfilia was born. in x777, layla did her duty with her keys and the stage was set.

in x777 layla released all her keys from her contract and was officially free of her own family’s destiny. she hugged her daughter tight and lucy made a friend that in another life, was an enemy: brandish. layla never died so grammi was never murdered by zoledo.

in x778, lucy expressed the wish to want to be a mage and use magic. layla, tactful as well as fearful, had her tutored for light magic through various books. of course, after teaching her the basics of all magic: the One Magic. she did not want her daughter to touch celestial spirit magic--the old burden still very fresh. so, caster magic it was.

in x779, lucy started to use magic, as well as brandish and the two would often play fight whenever grammi brought brandish over. nothing extreme, more just practicing spells. lucy was always a bright child and her writing had become even better and layla and jude could not be more proud of their daughter.

in x780, lucy and brandish wrote to each other often with brandish and her mother travelling. lucy missed her friend dearly and layla would make more effort in having her daughter feel less alone. in this timeline, lucy never felt neglected or unwanted: she felt loved and cherished. she was a bit more spoiled in this timeline, but still had a heart of gold and would often look for places where she wanted the heartfilia clan’s money to help aid. the orphan crisis from war, hungry people, the homeless crisis. all of it with good solutions that layla would read over before signing.

in x781, lucy’s light magic has been blossoming. layla and jude make the decision to seek a competent light magic user to fully tutor their daughter. nothing but the best for the daughter of the heartfilia konzern. even if the legality is covered in shades of gray they reach out to ivan dreyar, who was known to be intelligent and one of the very best who was independent. he agrees and lucy heartfilia meets ivan dreyar. in this year, lucy writes often to brandish about how smart her tutor is but also how much he expects of her which is a lot. lucy, always the optimist and hardworking, reaches each and every one of his goals.

in x782, brandish and grammi come back and ivan immediately has her battle brandish. the fight ends with a tie and ivan says the next time, lucy will win. lucy and brandish are still good friends and they spend a lot of time exchanging stories. lucy gets a taste of wanderlust from hearing of grammi and brandish’s travels. layla and jude watch their only daughter with pride as she becomes a stronger mage. layla attempts to reintroduce ivan in what conversations with adults are like and encourages him to speak and have a relationship with his son and mother. lucy also uses her magic in public for the first time. she also meets her first professional mages at a chairty event Gone Wrong when dark mages try to steal the money. she meets the strauss siblings of fairy tail and becomes enamored with them all (to ivan’s displeasure). the three of them keep up a correspondence with her from there on.

in x783, lucy’s wanderlust caught up to her and she wants to travel to a different part of fiore, at the very least. without her parents and ivan (who, at this point, is something of a third parent). her parents agree only after hiring mages to accompany her, should anything go wrong as she is a rich heiress. the mages they hire? the strauss siblings, who take this instead of an s-class quest since this one both pays more and they get to travel with lucy. ivan quietly broods as layla pours him some tea and jude asks him for his opinion on a business partner. there’s a reason why lucy thinks of him as a third parent. lucy meets her tutor’s son, laxus, when he visits. laxus is something of a jerk and lucy kicks him after ten minutes of meeting him. this makes laxus laugh and the two become friends as laxus and ivan restart their own familial relationship.

in x784, brandish and grammi return yet again and the two have missed each other a lot. lucy tells brandish of her crush on mira and brandish offers to confess to mirajane for lucy, to which lucy finally beats her in a battle. brandish and lucy both attend magnolia’s fantasia parade and lucy meets other ft members and also threatens makarov dreyar (to the amusement of both ivan and laxus. and to her parent’s quiet approval.). at the end of the summer of that year, key people from fairy tail dissappear and lucy regrets never telling mirajane how she felt about her. she and ivan both grieve and she comes out to ivan first, who then informs her that her parents would love her no matter what at this point, and lucy comes out to them. as always, ivan is right.

in x785, lucy heartfilia at 18 can finally go places without any supervision from her parents, her ivan, or people hired by her parents. she uses this time to travel around and have her own adventures as an independent mage (who does Not accept any cash from people). she writes home often, but does not return there. strangely, ivan is still there. she ends up meeting people from guilds: she runs into lamia scale’s team lyon and enjoys them all and trades stories with them. she pays for dinner. she meets some quatro cerberus members and parties with them and is hungover for two days after partying it up with DJ Hook Wizard Puppy. DJHWP is also responsible for hooking her up with a mage from MH, Viviana Webb.

in x786, Lucy stays closer to one place for the first time since travelling, but she has not joined a guild, nor has she returned home yet. ivan is still living at the Heartfilia compound. after ten months of dating, her and viviana webb break up on amicable terms. lucy once more, begins her travels and goes to iceberg. there, she meets a lot of different people and becomes more academically inclined here and goes to a higher learning facility, to ivan’s immense joy.

in x787, lucy runs into sherry blendy of lamia scale while they are both in iceberg. lucy and sherry hang out when sherry is not doing official business and both spend some time together. lucy gives sherry an open invitation to her apartment in iceberg. she also develops the tiniest of crushes on the Tragically Straight sherry blendy, but she does not regret it at all. it has been a decade since layla was freed of her ancestor’s destiny and she tells ivan the circumstances after two years of being in a relationship with him. ivan looks more into both the disappearances of tenrou, rumors of dragon sightings and dragon slayers. 

in x788, layla, jude and ivan make a visit to lucy in iceberg where she is presenting magical research she worked on at school with two professor and three students. they all are proud. lucy also learns that her tutor is dating both of her parents and all three of them are happy. later that year, DJ visits her by accident because he thought of her and missed her and she shows him what she has been working on as well as about her life here. she learns of the GMG in fiore and promises him she will go one year and cheer him on. after she graduates of course. lucy also is asked out by a fellow student, who she has been workign with and the two begin dating.

in x789, lucy and her girlfriend, gabrielle, move in together at the start of the year. well, gabrielle moves into lucy’s condo. lucy meets gabrielle’s family and brandish visits and is happy for lucy. the three of them go on a legendary bar crawl in iceberg that ends with all three of them laugh crying in the condo’s living room until they cuddle together and sleep. at the end of the summer, lucy graduates with honors with gabriella and all three of her parents are proud of her.

in x790, lucy finally attends the GMG and laughs at DJ’s shout outs to her as he is an announcer. gabrielle joins her in crocus and they make a vacation out of it. they watch as saberooth wins. sherry and viviana both tease her for supporting QC instead of lamia scale or mermaid heel and gabrielle laughs at her gf’s embarrassment. lucy is happy and her and gabrielle make it to the heartfilia compound at the conclusion of the games.

in x791, gabrielle proposes to lucy in the spring. lucy, who isnt ready for such a permanent life decision, rejects her. the two have a deep talk afterwards and once more, lucy amibably breaks up with her girlfriend. she goes back to fiore and finds out sherry is dating lyon vastia and makes her way to zinnia demanding details. in june, she returns home for a bit and ivan sits her down and explains that the GMG has something going on. he, layla and jude are going to investigate and since lucy is an adult, technically, she can join them. she does. when key fairy tail members return, both her and ivan go to magnolia and lucy is reunited with the strauss siblings as laxus and ivan are reunited with each other. during the games layla realizes that toma e. fiore went back on his word and in return, has Words with him with her husband and boyfriend watching. lucy takes photos. then, dragons come and well---it descalates from there and lucy works with the strauss siblings and DJ to help. when tatarus attacks, she is with the strauss siblings catching up and she aids in the crisis they present. she does a lot of releif work and ensuring the safety of others. her parents all give money to the destroyed home and her parents  begin to quietly investigate makarov’s movements. brandish and grammi give them grave news about the alvarex empire.

in x792, lucy spends a lot of time with the strauss siblings and finds herself around fairies a lot. she is teased a lot by laxus and the best response she has for him is that he is a mean step brother. which shuts him up easily. lucy meets more ft members and becomes instantly a fan of erza scarlet, a fellow sweet tooth. cana alberona is a fun one to drink with and lucy learns that because she did one bar crawl in iceberg did not mean that she could keep up with cana alberona. she meets lisanna’s best friend natsu and finds him simply wild but also fun to hang around with. her parents give the members of ft who were left without jobs various jobs and lucy gives some of them contacts where they can get work to keep afloat. brandish comes back from her travels without grammi. lucy helps her best friend plan a funeral that has no body.

fiore is given warning as alarez descends upon them. lucy finds herself fighting in hargeon with lamia scale with brandish by her side. ivan called in contacts of mages he used to know and it helps tip the battle in their favor. when acnologia descens upon them all, layla heartfilia’s heart almost gives out, but she along with levy mcgarden, work to make fairy sphere happen. acnologia is killed and layla, jude and ivan all hug each other. 

in x793, lucy does not live at home but she does stay in fiore. her and brandish live somewhat permanently in crocus, but the pair travel together more often than not. lucy uses her degree from iceberg and expands upon it at ivan’s behest and she does more research on ancient magics. she visits the strauss siblings a lot but soon, it becomes her and mirajane spending more and more time together. lucy does more research on transformation magic and discovers that mirajane is a prodigy at it but also: she was pushed to hard too quickly for the amount of souls. this turns into an intervention with mirajane about her magic and lucy takes it to ivan. all three of her parents present a case against makarov, aided by her step-grandmother, porlyusica stryne. in the end, fairy tail is disbanded for good by the council.

in x794, mirajane joins lucy at a conference in iceberg because lucy found out mira had never been. mira meets gabrielle and all of lucy’s friend and lucy easily translate. at the conference, the two hit it off more than expected and mirajane flirts endlessly with lucy. by the time they return to fiore, lucy moves in with mirajane where she is working for QC now, under the tutelage of Goldmine. DJ has never been happier.

lucy heartfilia grew up loved and happy. by the time she wrote her first fictional book, it is an lgbt romance between a demon and a princess. some may like to draw parallels to her life and the ones of the main protagonists, but the only character that was based off of lucy was an old hermit witch who never settled down. 

[jaidonschool]

PM Reflection & Contemplation

My role

PMI: Success under Resources, Scope, Time

Jaidon: Help people grow + learn PM + love others

SDN: Great conference + $

Fix problems and bring opportunities

Enforce process structure to keep momentum and progress IF a dependency group gets behind

Give fire connections / critique / mentorship to the team!

Experience: The progress is going well. Concept will need some quality refinement. We are growing a community.

Reflection:

• The setup time in the begging provided a good platform and spark for people to get to know each other as first priority.

• The team is handpicked, and has a big name behind us (heavy weight responsibility to rise up to) - so they have excitement to self organize.

• Because ATF was scattered in the beginning, reassuring friendly structure was very important to establish a positive work environment and faith in the project.

• The minimal overall timeline is good, because teams are autonomous and dependable enough to make their own sub timelines and meet the deadlines.

• Birgit is <3 <3 and encourages/enables the team inspiration - these professors are great at their jobs! We can leverage them for QC and motivation

• There may be health issues in the human structure (individual work SPEs) - but things seem better now that teams have broken up again

• With new members coming in, it’s hard to know how team dynamics might change

• While pushing further, it shouldn’t be limited to individual’s time use (more research, learning, output, experimenting). We can push by gardening the team (the plans are already VERY GRAND!)

Abstraction:

• Setting the dynamics in beginning, expectations, human structure, hand picked students, big SDN name, individual work focused SPEs, structure for belief, motivation, excitement, structure… the team’s “health” seems to be strong. We need to keep this up and not grow weary. But we can now focus on other areas.

• We seem to be hitting deadlines early, which leads me to think high quality work is important.

• We can push by involving more adjacent students (research, design for, offerings, etc.)

Experimentation:

• We could implement a “finalization process” where professionals give feedback/mentorship on deliverables.

• We can afford to do more research - This is something PM team can do - research reports!

• Bring in voice of diverse students: anthropology, art, CS, business, science, literature

• This user group is too big to do something designey - we either focus on conference being more general about student potential + create the future + PM, or we be more specific on design power for adjacent fields

• Should design better communication channels as the complexity of these teams and their needs proliferate

Personal boundaries / expectations

I can only do my best

• My learning is going STRONG, I invest 2 hours meeting, plus creating some documents and writing about my thoughts, plus reading articles/presentations + research.

• My dedication, investing open thinking, could be more systematic: use KOLB’s cycle, problem scanning and identifying, check in with prof’s what they think risks might be to anticipate problems/opportunities. I will dedicate an hour per week to open thinking about this project.

• In emergencies, I will work more than this. But until a problem arises, I’m chillin in #project-management, Sunday meetings, and lead team meetings.

• Another skill to level up is ninja communication skills (negotiation, helping, debate, etc.)

PM stress

• I am doing the best I can. I have mentorship, safe environment, dedicated contemplation time, personal expectations and boundaries. If problems arise, I can handle them, and if I can’t they must be really bad! I can just do my best, but I can’t save the world. ATF can help.

• My leadership style is calm, quiet, calculated. It is not spontaneous. It functions best when I can plan and have time to discuss with others. I am also good at inspiring and sending positive energy. My weakness is providing lamarckinian shortcuts in pressure times and judging what is desirable. I can do the thinking but can’t announce the vision (without experience).

• It’s not worth me having stress. I am setup for success, well equipped in habits, skills, and resources. It’s ok if I fail.

• I need to grow at setting limits.

Worst case plans

• If graphic design or concept is bad: critique / mentorship session to polish it up.

• If everyone quits (LOW RISK) - we make something simple and cool anyways!

• Tech fails DAY OF: we have a backup plan how we’ll deliver the talks and workshops (Zoom)

• Very few people come: They get to make friends with all of us!

• SDN gets mad it’s lame: lol it’s a prototype of what students can do

2 Friends advice

• What they think could go wrong

• What conference would be like

[biotechtimes]

Merck Life Science Careers – CMC Regulatory Specialist Job

New Post has been published on https://biotechtimes.org/2020/11/30/merck-life-science-careers-cmc-regulatory-specialist-job/

Merck Life Science Careers – CMC Regulatory Specialist Job

Merck Life Science Careers

Merck Life Science Careers – CMC Regulatory Specialist Job. Are you from a Life Science background? If yes, then there is an opportunity for you to join Merck India as a CMC Regulatory Specialist. Please check job details given below:

Job Summary

Roles are responsible for ensuring the Organization’s compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics.

Includes jobs which are not directly specialized in one of the other defined Regulatory Affairs job families or which are fully responsible for the whole functional area.

Job Title – CMC Regulatory Specialist

Job Location – Electronic city Bangalore

Job Requisition ID: 212490

Career Level: D – Professional (4-9 years)

Working time model: full-time

IMPACT: Impacts the results of own team with own contributions.

COMPLEXITY: Performs routine assignments using existing procedures OR works autonomously within established procedures and practices that require knowledge of concepts and procedures within a job discipline OR specialized technical expertise within an analytical/scientific method or operational process.

ACCOUNTABILITY/ INDEPENDENCE: Accountable for the quality of own work. Receives instruction, guidance and direction from more senior-level roles.

EXPERIENCE: Typically graduate background with little professional experience. Non-graduate jobholders require a substantial amount of professional experience and additional qualifications that also provides exposure to fundamental theories, principles and concepts.

EXPERIENCE: Typically reports to a Manager role, Project Manager role for a defined period of time based on organizational set-up (there is not necessarily a difference in role level between a manager and its direct reports – same level or lower level reporting is possible, provided job scope and responsibilities are clearly distinct); typically no direct reports.

Accountability/Interdependence

Provide end-to-end support for Annual Reports and Renewals for all products. Update and review CMC specific documentation, incl. coordination with countries to compile local CMC variations.

Impact

Ensure the provision of high-quality CMC dossiers that meet company’s and health authorities’ requirements. Enable representatives from all major disciplines involved to reach agreement on the CMC dossier and strategy

Complexity

The position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced CMC personnel

Education

Masters in a Life Science / Pharma or a related discipline.

Work Experience

5-6 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 3 years of Global CMC regulatory experience

Job-specific Competencies & Skills

Management and Planning: Ability to execute assigned tasks with support from team lead/mentor. Adherence to agreed timelines and proactive communication of any potential risk to the same. Provide high quality deliverables as per Organization standards, “right first time”. Solid knowledge of Organization systems and databases (APT, Trackers, RIMS/Veeva, EDMS). Familiar with Organization´s organization and able to identify relevant contributors and stakeholders within the organization as per project. Project management and documentation skills, proactive communication approach. Ability to provide standard presentation with minimal guidance and support.

Communication and Collaboration: Excellent written and spoken English language. Demonstrates proficiency in day-to-day business communication. Demonstrates proficiency in compiling and delivering presentations to a target group of people within the own area of specialization/ project environment. Consistently takes an active role in networking activities within own area of specialization/ project environment. Focuses on facts and quality of work rather than origin of ideas (does not follow cultural stereotypes). Recognizes other’s point of view and makes sure that everyone is listened to and understood. Pursues active networking across disciplines/ areas, projects.

Systems and Applications: User has advanced skills with all standard MS office and business applications (word, excel, power point, MS project, outlook, skype, SharePoint). User has contributor level of experience with RIMS and EDMS RA application. Upon completion of a dedicated training, user can perform routine/ standard activities within the RA systems with no supervision required. The output of the user will usually undergo standard QC/spot check procedure.

Regulatory Expertise: Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally. Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoA’s etc.) as well as legalization framework. Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request.

Pharma business acumen: Have a good understanding on how business operates and makes smart decisions trying to see the big picture without losing view of the details. Ability to understand and support the life cycle management of regulatory CMC activities Experience in management of regulatory CMC documentation, including variations. Experience with regulatory CMC life-cycle management activities. Practical experience in one of the following areas for biotech or chemical molecules: manufacturing process development, transfers, validation or analytical development and quality management. Awareness of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries.

Apply Online

[electronicproductdevelopment]

New Post has been published on Quality, Manufacturing & Product Development in China

New Post has been published on http://quality-manufacturing.org/setup-factory-production-line-manufacture-china-costs/

Manufacture setup in China: A short list of typical associated cost

Thinking about opening a manufacturing or a production line on your own in China instead of sub-contracting to someone already established locally ? Here is a short list of all the expenses you will have to deal with and a few stuffs you will need to take in consideration when doing so.

This article relate to what I have experienced and saw here in China when setting up and performing manufacturing and production management.

# Facilities cost

If you plan to manufacture then you will need space for your production line, for your warehouse, for your workers. You have to know that in China, most of the time, leasing contracts are usually established for 3 years, require a deposit refundable only if you respect your lease terms. Sometimes, the lendlord will not have setup electricity line and socket in the space you want to rent (sometimes the previous tenant would have removed them voluntarily to save penny!), so you will need to pay for this setup yourself. Unbelievable right ? Sometimes you will need to rework the floor (potentially dirty), walls or windows (as most of time building isolation in China is not of very high quality, if they don't close well, you better fix them to avoid spending too much on air con or heater if you set up one on the long term).

Rarely and not easily you will find manufacturing surface below 500 or 1000 sqm. Rent per sqm highly depends on the area where your spacing is located of course. Most of time if you are located in the downtown you will have to pay a very high price per sqm (take note than in Shenzhen the city doesn’t allow so much anymore manufacturing activity in the downtown area for city planning reason).

Of course when selecting the area where you plan to setup your activity, you have to take in consideration a certain number of aspects which might not be a problem or a constraint in the west. Just think about power supply for example: power shut off in summer when an all an area is pulling on air con heavily may bring some power cut off. This will affect your production efficiency because a power cut off will make your manufacturing line not running for several hours if not days the time that power come back to normal.

Think about internet connection quality too.Unusual things in the west, but in China, most of time your landlord will rent you an amount of X square mater but you have to expect to pay for 1.3 times this X value if not 1.4 times as they most of time consider the common parts such as public corridor, toilet or even lift space to be included in the rent and shared by all tenant on a single floor of a manufacturing plant. This  also apply for bills related to electricity and management fees of the building.

Hence, it is important to choose properly and carefully the location where you set up your production line. And believe me, but finding the right place can take ages. Here the market for those kind of facilities is extremly dynamic. Typically you visit a place at the morning, and you have to give your decision extremly quickly as the afternoon the same day someone may have taken your space.  

Too close to the city and the price for the rent will be very expensive. Too far from the city, you will have difficulties to find or retain some qualified workers and you may even need to supply them a dormitory room which would inflate your cost. Power cut and internet issue are also more frequent far from the cities in rural area.

When considering the space you need, you will have to evaluate properly the surface you need. Too small and you can not operate properly, too much space and you will waste money paying for unused space. Try to use the less space possible while being capable to perform your activity,  and try to stay lean as much as possible during your manufacturing activity. I quite often visit manufacturers who rent much more space than what they need because just they are not properly organized. Taking too much space can actually bring your company to a dirty financial situation quickly particularly if you are just starting.

Of course you need to be careful to have enough space to manipulate, store and perform all the operations and processes needed for manufacturing your product.

To optimize this point, the production line organization should be highly considered before renting. Not only do you need to consider your process and it required space, but you also have to consider the building room layout and make sure your line could accomodate properly in it configuration. Sometimes, it present some constraints such as width limitation, a column in the middle of a room or any other type of constraints such as reserved air extraction area. Yet, there are two advantages you can think of: in China you can easily make some changes in your room at relatively low cost.

What i usually do is to establish a production line simulation by drawing layout, local inventory store, space for workers, part spacing before to make sure enough space are available. I also use lean manufacturing toolset as it can help to decide how to organize a production line at best . U shape or any other configuration based on the floor space availability and configuration). 

# Human Ressources cost

Of course, if you have a manufacturing line, then you also need people. Living cost in China increased a lot in the last 10 years and particularly in those big cities like Shenzhen, so salaries have also increased a lot (but the skills didn’t increase at all). A basic worker cost easily minimum 4000 CNY per month, a basic QC easily 7000 CNY, a production manager easily 10000-12000 CNY. You have to provide them with job safety, sometimes even an accommodation, and of course pay their social insurance. This doesn’t include the cost of your time to recruit them, handle with administrative tasks such as pay roll handling.

If you take young people, you will probably face a potential instability (they jump very easily from companies to companies) without respecting their contract prior notice agreement, and you still have to pay them in this case as the law protect them more than it protects the employer. So, recruiting older workers will probably be better as they are more stable, but usually also slower to work. Recruiting and retaining good people in China while paying fairly but not overpriced is the biggest challenge in China. This is true for workers but also for other type of job. I regularly see some chinese engineer requesting very high salary not because their skills but because their age and the time they have worked in X positions. Sometimes, the salary they require versus the performance they supply make that you could hire a foreigner for cheaper (at equal productivity comparison).

The best technic is to test, test, and re-test people before recruitment and during probatory period, then to establish a clear career plan with some milestones they will have to reach to increase they salary. This technic is well adapted for engineer for example, but less for workers. I know most of them will consider "I have X years experience in A so my salary should be Y », but for me the salary increase should rather be indexed on their skills and result first, not based on a timeline. For workers, the best is to add a bonus on performance. Please note, I don’t say paying them per piece. I never pay workers per piece because it push them to go faster and faster usually leading to more problem such as more defects. It is better to pay worker per month, per day or per hour.

Install and use the lean manufacturing mindset to keep moral good among workers. 

Keep in mind that recruiting someone cost a lot of money via the time of ressource which is allocated for this process. It always cost less to retain someone than constantly recruiting and firing (still sometimes firing is necessary particularly for workers who are stubborn and don’t listen assignement). To retain people, try to install a good climate of camaraderie and friendliness.

# Equipment cost

If you manufacture some product you will need some items to help you with manufacturing.Those items can be machines, fixtures or tools. Those items add up to the bill and should be considered carefully. Sometimes it worth to sub contract some process requiring some expensive equipment rather than buying them.

# Utilities cost

Your production line will not run without electricity for sure and if you are in summer in the south of China, there is a high chance you may need air con potentially. Contrary to what people think, electricity in China is not that cheap. It worth mentionning that electricity cost for office and manufacturing place is twice the cost of housing electricity. Your people consume electricity via air con or fan, your machines consume electricity, your computer too. All add up very quickly.

You may also need water, this is usually cheap in China

You will probably need the Internet. Surprisingly, Internet is not cheap in China. It is even more expensive than in Europe with a quality of not so good. The infrastructure for it here are not of high quality. Strangely, you will notice that the Internet usually slow down when it is raining ! You may ask your self why. Well if you see how they set up telephone line here and how the cables are going into the sewage, you may imagine that rain may fill sewage and make a few stuff not working properly in the DSLAM area...

# Taxes

Yes, there are taxes to pay in China. First there are your human ressources which you have to pay their social insurance. This add up to the bill. Sometimes, depending on where you are located and what you are producing, you might need to pay some taxes on pollution (yes you have read well). There are taxes on companies for income.

Finally, a taxes which is not a real taxes but which can become one if you don’t pay attention to it is the VAT you pay when you usually export some goods. If you don’t get it back by claiming for taxes rebate due to the goods you export, then you might waste a lot of money. If you are in Shenzhen, the case is slightly different, but if you are in another city like Shanghai the custom authorities are very strict and any mistake you make on export claim will make you get a refusal and you will have to pay full VAT on export whereas you could have paid only a few of it.

# Safety compliance cost

If you have people in your manufacture, then safety compliance will be a concern. Think about fire extinguisher request by local fireman, special sign for exit, alarm etc… Sometimes the fire bureau will come to your place and will ask you to set up this and that threatening you to give you a fine if you don’t do it. Sometimes, they just say you don’t have it and claim for a fine straight away without warning. In some case they will find anything they can to give you a fine or claim for a bribe. The bribe issue is a common stuff in some area. Like anything it may represent a budget. I particularly made the choice to never enter into the bribe game otherwise it is just endless.

Sometimes, for safety compliance, you may need to set up some special machinery, such as air extractions. This is particularly the case for heavy soldering with lead and for painting. If you are in a special area, the local authority may require an environmental audit before you start your activity.

All those stuff add up on the bill and they have to be considered before taking the decision to set up a production line in China.

# Inventory costs

Depending on your manufacturing style and product type, you may need to store inventory. Inventory usually depreciate and fast speed. There is a risk of getting your inventory being damaged, stolen or lost. 

This inventory may then involved to contract an insurance to cover risks such as fire, flooding or thieves. 

On the top of making some cash flow being used to manage inventory, assurance cost will add up to the bill.

# Non quality cost

As you manufacture, your yield is usually not 100% so you have a bit some defectives (or sometimes a lot depending on how you manage your production process). Reworking part or product has a cost (Non Quality Cost). This cost, the manufacturer handle it, whereas usually the importer don’t directly. No quality cost not only affect physical items but also consume time of worker, consume time of managers, consume electricity due to machine runing again.

When you are on the manufacturing side servicing importer, the sight is totally different. I have been in both position, I now understand better what a manufacturer live. 

# Administrative cost

If you set up your own manufacturing, then you will need to register a company. Not only you may need to deposit a capital upfront to register the company but you will also need to pay some administrative and government fees (those vary from cities to cities), to pay an accountant monthly to handle your book keeping, and to pay an auditor to audit your accounting every year. 

# Your time cost

Yes, your time has a cost. How much does it cost ? You should know it yourself. To manage all those stuff, you will need to have an eye on everything almost all the time. You rill mostly need to be present on site all the time, at least at the beginning to set up the organization. 

With all those points, I am sure you understand it is worth to think twice before considering setting up your own manufacturing line versus sub-contracting it to someone locally based. 

Did I forget everything ? Feel free to comment.

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