Quality Management, GMP and Regulations - Impact on Food, Seafood and Nutritional Supplements
Jeff Morgan, Principal Consultant, JWM Associates, LLC
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||Course "Quality Management, GMP and Regulations - Impact on Food, Seafood and Nutritional Supplements" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Developing, manufacturing and maintaining a food or nutritional supplement product in the market is a complex and challenging task. At every step of the process, there is the potential that regulatory requirements will become barriers to the marketplace or in continuing services.
While news reports discuss the diminishing funds for many government programs, it seems that the FDA remains unaffected. In fact, FDA Warning Letters continue to rise in number, indicating that the need for compliance to the regulations is more important than ever. While it may be human nature to take on a "big brother is out to get us" attitude, the fact remains that the recipients of these enforcement actions have simply had deficiencies in their quality systems and processes.
The ripple effect has extended to websites that make health claims for products that have not been properly managed in today's regulatory environment. And it is important to note that the FDA need not send an investigator to the place of business. A few key taps can begin a web review that can effectively shut down a burgeoning web business.
While food processing inspections have been steady and ongoing, nutritional supplement manufacturers are now getting FDA’s attention. An area that previously flew under the radar, the nutritional or dietary supplement industry has regulations similar to that of medical device and pharmaceutical companies, which are much more complex than food regulations. However, unlike the device and pharma regulations, dietary supplements' regulations are presented by the FDA in a reader-friendly Q and A format in addition to the stiffly-penned regulations. As a result of increased scrutiny, Warning Letters to dietary supplement manufacturers have steadily increased over the past three to five years.
Upon completing this course participants will:
- Understand the importance of food and nutritional supplement GMPs in protecting the public
- See the impact of poor GMP performance
- Become a HACCP subject matter expert
- Understand the impact on product quality and on business success
- Know how facility design affects product quality
- Understand the dos and don’ts of product promotion, websites and social media
- Learn about GMP validation – when is it required?
- Understand how cleaning agents work and the best way to choose a cleaning agent
- See the impact of proper documentation and record keeping
- Understand why cleanliness is the key to success
Who Will Benefit:
This course is designed for people tasked with maintaining and improving compliance to 21 CFR part 110 and 111 standards for food and nutritional supplement manufacturers. The following personnel will benefit from the course:
- Start-up food and nutritional supplement companies
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Food and nutritional supplement production supervisors
- Process owners
|Day One (8:30 AM – 4:30 PM)
||Day Two (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- What are quality and Quality Management System (QMS)
- Why is QMS important
- What dose it take to institute a QMS
- Related regulations
- Food and juice
- Special requirements for seafood
- Nutritional supplements
- Health considerations for consumers
- Recent FDA inspection trends
- How this affects a business in the end
- Why implement a formal QMS?
- Cost of implementation is less than cost of continually addressing problems
- Investing in your product/service/company as a matter of pride
- Quality ≠ Perfection; Quality = Responsibility
- Steps to successful quality
- Questions and Answers
- Review session I and session II goals
- Rats, bugs and GMP – cleanliness and sanitation
- Participant exercise
- Government oversight and enforcement
- Assessing when things can go wrong and learning to prevent problems
- Common infractions and what they mean to the business
- How to properly respond to government findings
- Statistics on FDA enforcement
- The cost of non-compliance
- Questions and Answers
Meet Your Instructor
Principal Consultant, JWM Associates, LLC
Jeff Morgan has over 30 years of combined experience in medical device consulting, development of medical devices and clinical laboratory management. His expertise includes quality systems (FDA QSR, ISO 9001 and ISO 13485) consulting and auditing, CLIA compliance consulting services and FDA submissions assistance for food, nutritional supplements and medical devices. Jeff also provides consultation in the areas of SOP development and technical writing, management of technology transfer and scale-up, validation protocol development, and in-vitro diagnostics research and development assistance.
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