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Importance of Quality as Work Culture in Food & Pharmaceuticals Manufacturing

Good manufacturing practices, developed in the past 20 years, have introduced new hygienic rules that limit contamination by pathogenic and spoilage bacteria. Consumers are more aware of the quality and storage of meat and of the safety measures taken during its preparation. However, several criteria other than eating quality play an important role in meat acceptability, e.g., price of meat, attitudes and knowledge of consumers towards meat, and convenience in preparing meat. “It’s difficult to find anyone who says food safety is not important, but people don’t always realize that when you do good for food safety, you do good for the business,” Hernandez said. … “A strong food safety program and discipline provide benefits that go well beyond food safety.”

These are the key factor of Food Safety Standards:

Food Safety is Good for Business

Impact on Businesses & Study

Hazard Analysis & Critical Control Point

GMP In Food Industry

Food Safety Is Good For Business: For food safety professionals, the first order of the job is to think about the safety and quality of the product. But, said US Foods Senior Vice President of Food Safety and Quality Jorge Hernandez, “Food safety, and the systems that provide for an infrastructure of safe food products, is often seen more as a cost of doing business rather than a source of positive impact to the business.Impact on Business & Study:  These requirements impact business sector like food processors in every country as consumers are demanding better safety and quality.Hazard Analysis & Critical Control Point: HACCP is used at all stages of food production, from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.GMP in Food Industry: GMPs describe the methods, equipment, facilities, and controls for producing processed food to produce high quality and safe products and are generally specified in regulations.Pharmaceutical Manufacturing CompaniesTo monitor compliance of pharmaceutical companies with cGMP regulations, the FDA routinely performs facility inspections and reviews publically generated product reports. Companies not in compliance with cGMPs are issued a warning and may become subject to regulatory actions. Although the

FDA

cannot force a company to recall a drug when compliance is not met, violations can be legally addressed and a court order can be granted allowing the seizure and disposal of drugs. However, patient health is still at risk when these pharmaceutical products are not immediately removed from the market.Conclusion:In response to these outbreaks, both the enforcement of and the quality control regulations that pharmaceutical companies currently operate under must be scrutinized and updated. In contrast, compounding pharmaceutical companies are minimally regulated, do not require drug approval, and are not legally required to report the production of an adulterated parenteral drug. Additionally, many of these compounding companies regularly operate outside the boundaries of the FDCA by functioning inappropriately as a drug manufacturer.

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FDA's New Inspection Policy and Strategic Regulatory Updates 2018

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment.

In this webinar expert speaker, Carolyn Troiano will discuss the key challenges that are presented during computer system validation and how to overcome them to avoid some of the most common problems that are identified during FDA inspections.

Session Highlights:

Learn how to document Computer System Validation (CSV) efforts to meet FDA compliance

Learn the most common pitfalls and challenges encountered when preparing documentation for FDA review

Learn about the best practices for documenting CSV efforts in alignment with the System Development Life Cycle (SDLC) methodology

Learn about CSV and what is required for FDA compliance

Learn about industry best practices related to compliance and computer system validation

Understand strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11

Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process

Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state

Learn how to gain information about trends invalidation, as the industry progresses and new best practices emerge

Understand some of the industry best practices to apply when following the CSV process according to the SDLC methodology

Why You Should Attend:

In this webinar attendees will understand the specific ways to document your computer system validation work to ensure it meets FDA requirements and can pass an inspection. There are specific requirements that must be followed in order for the Agency to consider the documentation valid, and without following these, there is a great risk of FDA invalidating work.

Who Should Attend:

QC/QA Managers

QC/QA Analysts

Analytical Chemists

Compliance Managers, Laboratory Managers

Manufacturing Managers, Manufacturing Supervisors

Supply Chain Specialists

Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance, and audit

Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Auditors engaged in the internal inspection of labeling records and practices

Ask your question directly from our expert during the Q&A session following the live event.

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Marijuana Laws Update: California and Other States

Clearing the Air: Marijuana in the Workplace- How to navigate the “legalization” of marijuana and other issues of drug use and drug testing.With the probability medical marijuana may be more frequently prescribed for many recognized disabilities, employers may want to dust off their policies around drug use and impairment in the workplace. This webinar will help you to understand that what circumstances an employer may discipline an employee that appears impaired, even if the impairment is because of medical marijuana for a verified disability.In this webinar expert speaker Jennifer Raphael Komsky, will help you how to manage a positive drug test with no known indicators of impairment and issues of drug use and other testing. Will also discuss the current status of state laws legalizing marijuana in conflict with federal laws criminalizing. Provide background checks for drug convictions that are no longer illegal- When can they be conducted? What information can be obtained? What information must be provided to the applicant about the process?Session Highlights:Learn to navigate the landscape of conflicting laws about marijuana and other substancesAcquire knowledge about when and how an employer may take action against an employee suspected of using marijuana either for recreational or medical useObtain knowledge about when and how to legally conduct drug screenings/testingLearn how to avoid disability discrimination claims when an employee has a medical marijuana cardWhat drug and alcohol policies should be in place to ensure compliance with state and federal laws?Why You Should Attend:This presentation will provide guidance in coordinating the recent legalization of recreational and medical marijuana in California and other states and jurisdictions with the need to keep the workplace drug free. Being proactive and knowledgeable about the limits imposed by law on both individuals and employers will alleviate many employment problems for the duration of the employment relationship. This program is essential for anyone tasked with the recruitment, hiring or managing of employees.Who Should Attend:Business ownersManagers And SupervisorsHR GeneralistsAdministrative AssistantsHR Payroll StaffAsk your question directly from our expert during the Q&A session following the live event.

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The Role of Student Handbooks and Codes of Conduct in Education Risk Management

"Learn the Importance of the Material a School Utilizes in it Student Handbook"

In the past, handbooks aimed at students in colleges and universities have contained basic information regarding topics such as academic standing, student discipline, housing rules and campus directories. However, evolving and advancing technology has forced both students and institutions to include much more information for the protections of both groups. This webinar will allow students, administrators and faculty to understand the changes in policies and what needs to be included in today's (and tomorrow’s) student handbooks.

In this webinar expert speaker Kent Seaver, will be discussed that student handbook can work in many different ways: informative piece, reference device, and legal shield. The overall safety of your campus is not only important, but how that is achieved and perceived can be the difference between success and failure. Knowing these roles is important to all stake holders in colleges and is just reason you should attend

Session Highlights:

Understand the role of academics in handbook policy

Discuss student discipline policies in depth, including Title IX

Delve into the impact of residential and Greek life as they relate to Risk Management

Learn and analyze the impact of student organizations and activities

Discuss Best Practices to prepare employees, students and parents for college life Why You Should Attend:

In this webinar attendees will learn the importance of the material a school utilizes in it student handbook. The importance of Risk Management has never been more important, and polices such as discipline, housing, student organizations, and Title IX play a much larger role in institutional life than ever before. Every institution in the nations needs a set of guidelines that allows faculty, staff and students to have unfretted access to an instructions educational resources.

Who Should Attend:

Campus Stakeholders

Campus Administrators

Student

Residence Coordinators

Faculty Advisors

Ask your question directly from our expert during the Q&A session following the live event.

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Payroll Deduction – Mandatory Taxes, Courtesy Taxes and much more

"Payroll Deduction - Which Taxes are Mandatory, Which are a Courtesy"

In payroll we calculate the gross wages of an employee by meticulously following strict regulations on what must be or must not be counted as hours worked and taxable income. We pay the employee their net paycheck only by the payment method that is permitted.

Of course everyone knows that payroll deducts for federal and state taxes. However, how much input does the employee have concerning these deductions? This will be answered in this webinar. Which taxes are mandatory, if the IRS or the state wants payroll to collect for back taxes; how is that processed? What does payroll do if a “payday loan” deduction is received as opposed to a creditor garnishment? Which ones must we honor and why. We will discuss this during this webinar.

In this webinar expert speaker Vicki M. Lambert, will be answered which taxes are mandatory, which are a courtesy and which ones the employee controls will be explained during this webinar. If the IRS or the state wants payroll to collect for back taxes; how is that processed?

Session Highlights:

Taxes—which are mandatory, which are a courtesy, and which ones the employee controls

Tax levies—federal and state

Creditor garnishments—how many can you honor and how often

Voluntary wage assignments for “payday loans”—when are they required to be honored

Handling fringe benefits such as health insurance or group term life

Uniforms—when the employer pays for it and when the employee furnishes it

Meals—when they become part of the employee’s wages

Shortages—the employee came up short so they have to cover that right?

Breakage—you broke it so you have to pay for it, legal or not

Overpayments—the employee was overpaid so you can just take the money back or can you?

Advanced vacation pay—the employee knows the vacation hours were advanced so we can take them back when the employee quits can’t we?

Loans to employees: what terms can be set while the employee is still active and what can be taken when the employee terminates

Employee purchases—active employees and terminated employees

Why You Should Attend:

In this webinar, Speaker will discuss what can and what cannot be deducted from an employee’s regular paycheck as well as their final one. Failure to follow the regulations pertaining to employee wage deductions can result in substantial penalties and interest. How to process voluntary and involuntary health insurance deductions. You will come to know about deductions on basis of uniforms and meals/lodging, etc.

Who Should Attend:

Payroll Professionals

Human Resources

Accounting Personnel

Business Owners

Lawmakers

Attorneys, or any individual or entity that must deal with the complexities and technicalities of ensuring compliance within the payroll process

Ask your question directly from our expert during the Q&A session following the live event.

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The Impact of New FSVP & Third Party Accreditation Rules on Your Food Business

The wait for final FSMA Rules is quickly ending and the implementation periods have begun. On November 10, 2015 the FDA published the final rules for the Foreign Supplier Verification (FSVP) and Third Party Accreditation programs and is now preparing guidance documents that extend the requirements previously published under the final rules for cGMP, Hazard Analysis and Risk-Based Preventive Controls for Human and Animal Food. Most businesses have less than one year for full implement compliance implementation. 

Since the final FSVP and 3rd Party Accreditation rules rely heavily on new rules for HARPC, Environmental Monitoring, Validation and Validation of Preventive Controls. In this webinar expert speaker John Ryan will review earlier final rules and he summarize the final FSVP and 3rd Party Accreditation rules. It is critical to begin to understand how the FDA has interwoven the FSMA  into more of a compact and focused set of rules than proposed rules might have led us to believe. 

The FDA FSMA rules are based on the ideas that risk can be reduced through preventive approaches not widely understood or followed in the food industry. Regardless of your ability to understand these new rules, the implementation period has begun. The waiting period is over. Session Highlights: Understand how the new rules will impact your business Learn how to improve control over suppliers Review basic rule requirements Prepare your business to comply with changing food safety and quality standards and audits Find out who is exempted Evaluate Food Risk and Supplier Performance Subpart G – Supply-Chain Program Validation of Preventive Controls Environmental Monitoring Requirements Hazard Analysis Review Requirements for Accreditation and Certification Bodies Begin to bring your internal food safety systems up to date Understand FSVP and 3rd Party Accreditation reporting requirements so you can protect your company. Know about conflict of interest between your company and 3rd Party Bodies Why You Should Attend: The implications of these newly published FSMA rules go far beyond what their titles imply. Based on FDA recommendations, we are presenting this critical session so that domestic and food importers and exporters can begin to protect themselves. More importantly, the Third Party Accreditation Rules need to be understood by all food industry personnel because earlier established food safety standards and audits will be changing to accommodate the new rules. Who Should Attend: Food producers, shippers, carriers and processors Food Safety Certified Auditors Food company CEOs, VP and Director Level Personnel Internal Food Safety and Quality Team Members Food Testing labs and Quality Personnel cGMP Specialists Operations personnel Ask your question directly from our expert during the Q&A session following the live event.

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Transportation Food Safety Standards for Shippers, Carriers and Receivers

While the FDA Food Safety Modernization Act (FSMA) rules for the sanitary transportation of human and animal foods require training for rail and road carrier transportation personnel, training is only the tip of the iceberg and does not certify carriers or shippers in food safety. The deadlines for large company full compliance to the sanitary transportation rules has passed and April 6, 2018 is the final deadline for all “small” carriers of “food not completely enclosed by a container”.

The company’s responsibility under FSMA is to assure that there are transportation standards established, a plan is in place to document and meet the plan, the plan is verified, and there is some proof that the sanitation and temperature controls in place work to eliminate bacterial, chemical and physical contaminants in order to prevent food from becoming adulterated during transportation processes. For most companies, the deadline for plan development and implementation has passed.

In this webinar expert speaker John Ryan will cover management, sanitation, temperature and traceability and prevention standards, procedures, some documents and sanitation and temperature controls that meet and validate sanitary food transportation rule compliance.

Session Highlights:

Understand the new FDA FSMA sanitary transportation requirements

Develop a company transportation system to satisfy the FDA and control food safety in your operation

Understand internal and external compliance requirements

Work collectively to develop a valid food transportation preventive controls plan

Know where to find all appropriate planning forms and documents

FDA FSMA Sanitary Transportation Rule Requirements

Management Standards

Sanitation Standards

Temperature and Traceability Standards

Preventive Control Standards

Documentation and Procedures

Cell Phone Supply Chain Data Collection

Why You Should Attend:

Most companies are without the guidance or information needed to get them on track to become certified and fully documented in order to prove compliance. Shippers and carriers must establish, agree on, implement and document adherence to standards that comply with the FDA’s sanitary transportation rules.

This webinar will cover food safety standards designed specifically for the perishable food transportation part of any company’s overall food safety plan. The standards were developed to fit neatly into most company’s food safety systems, are easy to understand and include a preventive component designed to answer the most critical FDA auditor question “How do you know your procedures work?”

Who Should Attend:

Food Transportation Managers

Shippers, carriers and receivers of perishable foods

CEOs, VP and Director Level Personnel in food companies impacted by FSMA

Food Safety and Quality Team Members

Quality System Personnel

Operations and compliance personnel

Documentation, data, management analysis and recall team members

Ask your question directly from our expert during the Q&A session following the live event.

Visit At https://www.edupliance.com/webinar/fda-fsma-new-sanitary-transportation-compliance

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ACA Reporting Requirements 2018

Affordable care act was signed into law by president Obama on March 23, 2010 and since then employers have been asking themselves how to comply. The law changed how companies provided benefits, calculated payroll tax and most of all the new reporting requirements that must be followed. Now the employers have had 2 filing years to get used to the ACA law, the Trump administration is looking to repeal portions of the law. This webinar with expert speaker Dayna Reum is designed to review Section 6055 and 6056 requirements and the reporting requirements, and to review what the potential changes might be and how that changes how we handle, benefits and payroll for our employees in the next months. Talks of repeal of the ACA or modifications have been all over the news as employers this webinar will discuss how to prepare in an unsure environment. Session Highlights: Up to date status on legislation and how it may impact employers What reporting may or may not look like for 2017/2018 Review of what we know today Overview of law in place and if you need to report Affect to Payroll Current law vs. what a repeal may look like Affect to Fair Labor Standards Act will a repeal affect this FLSA changes Reporting Requirements Shared Responsibility what now Other ACA Requirements Why You Should Attend: This webinar will review lessons learned from last year along with how we can make this process easier moving forward. We will also review common issues that the IRS seen and how we can avoid them. We will also discuss in brief the anticipated future of the ACA. Who Should Attend: All Payroll Professionals HR Professionals Benefits professionals Accounting and Tax Professionals Business Owner Ask your question directly from our expert during the Q&A session following the live event.

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Fair Housing: Reasonable Accommodations – Assistance Animals , Disability Discrimination and more

Reasonable accommodation is one of fair housing’s “hot topics”. This typically accounts for over 50% of the fair housing complaints to HUD in the past year. Reasonable accommodations can be requested during the application process, during tenancy and during an eviction. It is important to learn the correct procedure to ask for, review and implement this important action. Reasonable accommodations are requested because of a disability of either physical or mental issues. It is important that one understand the definition of disability and when it come into play to allow a disabled person to enjoy the same quality of life as an non-disabled individual.In this webinar expert speaker Paul Flogstad will explore the misunderstandings and best practices of particular relevance to small employers when accommodating employees with disabilities in and around the workplace.Session Highlights: Definition of reasonable accommodationDefinition of disabilityWhen an accommodation is neededDeference between an accommodation and modificationUnderstanding of companion animal/ service animal issuesUnderstanding what is “reasonable”Understand fair housing issues and how they impact your propertyUnderstand the need for accommodationsUnderstand the fair housing laws about accommodationsKnow time frame for requesting and granting of accommodationsWhat properties fall under fair housing/ accommodation lawsWhy You Should Attend:This will be a real world course. It is just not textbook answers but solutions and examples of what is “real world”. Instructor has much fair housing experience and will share through actual experiences to enhance learning. This course will provide you with the ability to make the correct decision when faced with a reasonable accommodation request. Typically property owners do not want to be charged by HUD for a fair housing violation and the costs incurred by the complaint. This course will give guidance to avoid being charged in the first place.Who Should Attend: Property OwnersProperty ManagersHousing Authority StaffCompliance Staff RealtorsMaintenance staffReal Estate ProfessionalsAsk your question directly from our expert during the Q&A session following the live event.

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Employee Retention Strategies That You Need To Know

An effective employee retention program looks through the team’s point of view. It addresses concerns related to their desires, goals, appreciation for their work and assurance of being paid fairly. It also helps that they are both excited and challenged by their job.  But it also goes beyond the basics. Your efforts should actually start on a new hire’s first day on the job as the training and support you provide from that day sets the tone for the employee’s tenure and the path for job satisfaction.  

Here are the key strategies to improve your organization’s employee retention and boost employee satisfaction:

Onboarding and orientation — Every new hire should be set up for success from their very first day at the office. Job orientation is just one component of onboarding which may last a few weeks to a month. Employers must develop an onboarding process where new hires not only learn about the job but also the company culture and how they can contribute and thrive, with ongoing discussions, goals, and opportunities to address questions and issues they might face.

Employee compensation — Companies must offer attractive compensation packages to stave off poaching from other companies. This includes salaries, bonuses, paid time off, health benefits and retirement plans. 

Training and development — Professionals want the possibility for advancement in their industry. Smart managers invest in their workers’ professional development and seek opportunities for them to grow. Some companies pay for employees to attend conferences or industry events each year or provide tuition reimbursement or continuing education training. 

Mentorship programs — Pairing a new employee with a mentor helps them learn the ropes from a veteran with a wealth of resources. They can offer guidance and be a sounding board for newcomers, welcoming them into the company culture. 

Work-life balance — Burnout is a very real issue if you constantly expect long work hours from your employees. A healthy work-life balance is essential. Management should make sure to encourage staff to take vacation time, allow some flexible work and schedules, and telecommuting to improve work-life balance for their employees.

Recognition and rewards systems — Every person wants to feel appreciated for what they do. Make it a habit to thank your direct reports when they go the extra mile, whether it’s with a sincere email, a gift card or an extra day off. Set up rewards and recognition systems that incentivize great ideas and innovation. Celebrate major milestones for individuals and for the team. 

Communication and feedback — Your employees should feel comfortable in approaching you with ideas, questions, and concerns.  You are also expected to be honest and open about improvements they need to make in their own performance Make sure you connect with each staff member on a regular basis — don’t let issues build up for the annual review. 

Fostering teamwork — When people work together, they can achieve more. Foster a culture of collaboration that accommodates individuals’ working styles and lets their talents shine. Do this by clarifying team objectives, business goals and roles, and encouraging everyone to contribute ideas and solutions.

Visit At https://www.edupliance.com/blog/4/18

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How Can HR Prevent Sexual Harassment In The Workplace

Sexual harassment is a disagreeable or an unacceptable act which causes a victim to feel like exasperated, embarrassed, and terrified. It arrives in many forms such as verbal, physical, or written. It is considered to be associated with the workplace when it occurs with someone at work, or while attending work-related events. An employer or HR manager should be able to rapidly resolve any concerns related to sexual harassment irrespective of whoever is the culprit or victim. Sometimes the victim of the harassment may not be able to communicate their issues to their supervisor but it does not mean that they are accepting of such behavior. HR possesses a key responsibility to build and sustain a workplace environment that is completely clear of sexual harassment. Apart from being a legal commitment of the employer, it also makes good business sense.

It is crucial for HR to have some prevention strategies for the prevention of sexual harassment in the workplace, some of which have been discussed below:-

Follow a clear anti-harassment policy The employer should clearly mention these points in their employee handbook:

Proper definition of sexual harassment State in clear words that any kind of sexual harassment will not be tolerated or accepted within the workplace State that HR will definitely discipline or fire any employee who harass other employees Display a clear agenda for filing complaints regarding sexual harassment State that HR will properly inspect any complaint that are reported State that an employer will not admit or accept any reprisal against anyone who objects about any sexual harassment Conducting awareness training of all employees, supervisors and managers HR should execute annual training sessions for employees which would train employees on awareness about what sexual harassment is and how to prevent it. It should teach them that they have a legal right to have a work environment devoid of any form of sexual harassment and an employer should make sure that all the employees understand the procedure for filing complaints, be aware of their options in that situation and are motivated to report to their respective managers and supervisors of the incident occuring.

Monitoring the workplace HR should be proactive in observing the workplace. They should get out among the employees themselves periodically to get insight on their work environment. If they see any offensive posters or notes, an immediate action should by HR to address the negative environment. Respective supervisors and managers should make sure all communication lines to them are open.

Take all the complaints seriously Immediately investigate any and all complaints related to sexual harassment. If its a genuine complaint, HR’s actions against the perpetrator should be swift and effective.

Visit At https://www.edupliance.com/blog/post/3993

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Section 504 and ADA : Student Disability Rights

The entirety of Section 504 is comprised of one sentence: "No otherwise qualified person with a disability in the United States...shall, solely by reason of...disability, be denied the benefits of, be excluded from participating in, or be subjected to discrimination under any program or activity receiving federal financial assistance." But what does this mean in the practical context of a post-secondary education, and what is expected of schools? Since the implementation of Section 504 and, later, the ADA, courts have been busy analyzing the language and deciding student disability rights issues. In this session, Erin D. Gilsbach, Esq. examines 10 prominent court cases that provide an expansive look at the legal expectations of student disability rights at postsecondary institutions. Through this process, she breaks down the key components of nondiscrimination and provides helpful tips on what it takes for postsecondary programs to pass muster under Section 504 and the ADA. Session Highlights: Provides a brief, accurate, and convenient summary of the requirements of Section 504 and the ADA as they apply to postsecondary schools – a helpful quick overview Analyses the issue using case studies, so that the process is clear and easy to understand Provides tips and best practices for schools to ensure legal compliance and limit potential liability Why You Should Attend: This session uses key case studies to demonstrate key Section 504 and ADA concepts as well as areas of potential liability. The presenter will illustrate the significant requirements of both laws through analysis of the 10 cases, and she will provide best-practice tips to help schools minimize potential liability and effective accommodate students with disabilities. She will also discuss the 2016 changes to Section 504 and how those changes impact institutional responsibilities. Who Should Attend: This session would be valuable for both K-12 and post-secondary level employees. Post-Secondary: HR officials Deans of Students Dorm Monitors Student Activity Advisors Professors Disability Advocates Attorneys/Solicitors K-12: Superintendents and Assistant Superintendents Building-Level Administrators (Principals, Assistant Principals, etc.) Pupil Services Personnel / Deans of Students Ask your question directly from our expert during the Q&A session following the live event. Visit At https://www.edupliance.com/webinar/from-cases-to-concepts-a-discussion-of-student-disability-rights-through-the-explanation-of-10-key-cases