Course Description:

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.

Learning Objectives:

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

Course Outline:

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

Jeff Morgan,
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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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

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Media Partners


Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.

Local Attractions

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.

The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity

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