FSMA Update - Overview Three Sweeping Rules: Foreign Supplier Verification Program Rule, Third Party Auditor Accreditation Rule, Preventive Controls Rule and GMPs for Animal Food/Feed Rule

Why Should you Attend:

The proposed Foreign Supplier Verification (FSVP) rule will place a new burden on importers - importers will be responsible for identifying hazards and conducting various verification activities to ensure hazards are effectively controlled. The accreditation rule and FSVP work closely together. Only inspections completed by third-party auditors accredited under the new accreditation rule will be recognized by customs agents. The preventative controls rule for animal feed will impose the first serious regulation of the industry. The rule mandates Good Manufacturing Practices for the first time along with new preventive controls provisions.

This webinar will help importers and foreign suppliers of food and dietary supplements to understand the new rules and how to comply to import products once the rule goes into effect. The preventive control provisions are unique and unlike anything in HACCP or the preventive control rule for human food.

Learning Objectives:

During this webinar, you will learn:

• FSVP
• What is a Foreign Supplier Verification Program
• Defining a hazard analysis
• Required verification activities
• How to determine when the FSVP rule applies to the importer, foreign supplier, or customer of the importer
• How are dietary supplements regulated
• Other functions and potential impact of the rule
• Third Party Auditor Accreditation
• When auditors are required
• How auditors and accrediting institutions qualify
• Accreditation withdrawal/revocation authority
• Animal Feed
• Defining a hazard analysis
• Features of a food safety plan
• Defining a qualified individual
• Required verification activities
• Other functions and potential impact of the rule

Areas Covered in the Webinar:

• The basics of a FSVP Program, food safety plan, and accreditation for third party auditors
• What is an audit (who can conduct it, frequency, on-site, testing etc.)
• Hazard Analysis
• Verification Activities
• Impact of an outbreak
• Who bears what responsibility
• Exemptions
• Overlap with Preventative Controls and Produce Safety rules

Who Will Benefit:

• Food & beverage industry executives
• Dietary Supplement manufacturers/distributors
• Food manufacturers/distributors
• In-House Legal Counsel
• Regulatory Affairs
• Government Affairs
• Distributors and manufacturers
• Customs brokers and Importers
• FDA/Food & Drug Attorneys

Instructor Profile:

Marc C. Sanchez, represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. He also teaches as part-time adjunct professor at Northeastern University on regulatory topics including US and international food law and regulation.

With a focus on international trade, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. Marc is a frequent national speaker on FDA compliance issues affecting the food, dietary supplement, and medical device industries. He is also considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S., with interviews and contributions in the Washington Post and Huffington Post.

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