On Demand: FDA Inspection Trends, cGMP Compliance Issues and Responding to an FDA 483

Upcoming Webinars

On Demand: FDA Inspection Trends, cGMP Compliance Issues and Responding to an FDA 483

Recorded Nov. 30 and Dec. 14

Published: Thursday, November 30, 2017

Event date: 12/14/2017 1:00 PM - 3:00 PM Export event

Legal experts provide an update on FDA inspections, emerging cGMP compliance issues, strategies for responding to an FDA 483 and answers to your specific questions.


Event Details

Dates and Times: 
Part 1 Recorded Nov. 30
Part 2 Recorded Dec. 14

Cost:
$199 (AHPA Members)
$399 (Non-Members)

This webinar helps businesses in the dietary supplement industry understand the elements of current Good Manufacturing Practice regulations (21 CFR 111) that have been the primary focus of recent FDA inspections. This knowledge will assist business in allocating and directing their compliance resources.

This two-part webinar provides data on recent FDA inspections, an overview of emerging compliance issues and strategies for responding to an FDA 483 in order to avoid an FDA warning letter.

Part 1 -- Recorded November 30

Veteran industry legal experts provide an insider's view of the current cGMP enforcement landscape and strategies for compliance. AHPA staff offer a detailed analysis of the association's repository of inspection data, which includes actual FDA 483 inspection reports, observation forms, and establishment inspection reports (EIRs).

A 30-minute Q&A session answers attendees specific questions.

Part 2 -- Recorded December 14

An extended Q&A session addresses attendee questions. Legal experts then provide strategies for companies to effectively respond to an FDA 483 in order to avoid getting a Warning Letter. Learn tips for conducting an FDA inspection.

Topics

  • Own label distributors and contract manufacturers: What are the differences and what aspects of the cGMP are you responsible for during an inspection?
  • Own label distributors and contract manufacturers: What are the differences and what aspects of the cGMP are you responsible for during an inspection?
  • FDA inspection practices and what can be done to prepare
  • Detailed analysis of recent FDA inspection reports
  • Effectively responding to an FDA 483 so as to avoid a Warning Letter
  • FDA inspection do's and don'ts
  • Answers to your questions during the extended Q&A session

Presenters

  • Anthony L. Young, Esq., Partner, Kleinfeld, Kaplan and Becker, LLP / AHPA General Counsel
  • Alan Feldstein, Esq., Of Counsel, Collins Gann McCloskey & Barry PLLC
  • Merle Zimmermann, Ph.D., Information Analyst, AHPA
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Webinar Recordings

Debriefing the FDA's cGMP Implementation Seminar

Presented: October 25, 2007

This debriefing provides expertise to answer specific questions and dispel any confusion that arose from the FDA overview of cGMP implementation guidance.

Serious Adverse Event Reporting (SAER): Strategies for Compliance

Presented October 16, 2007

AHPA presents strategic regulatory, medical and legal perspectives to help companies comply with the Dietary Supplement and Nonprescription Drug Consumer Protection Act

cGMP Compliance Series: Good Manufacturing Practices: The Final Rule

Presented: July 12, 2007

This educational event will help you learn exactly what you need to know about the dietary supplement cGMP requirements, including the necessary processes and procedures need to ensure compliance.

Structure/Function Claims: Crafting Smart & Lawful Marketing Info & Labels

Presented: June 28, 2007

The limits placed on what you can and cannot claim about your product are key elements of the laws that affect dietary supplements. Every marketing plan must balance what federal law allows, what is informative to consumers, and what may drive sales.

cGMP Compliance Series: The Quality Unit

Presented: December 14, 2006

As described in the cGMP rules, your company must establish a Quality Unit, an independent group with unique responsibilities and authority to manage product excellence, consumer safety, compliance, company liability.

cGMP Compliance: Botanical Identity & Herb Quality

Presented: September 28, 2006

This webinar is designed to help companies evaluate ingredient identity and quality and comply with FDA’s dietary supplement cGMP rule.

Allowable Claims and Claim Substantiation: How to Comply with the Law & Maximize your marketing

Presented: August 3, 2006

Many companies have learned the hard way that the Federal Trade Commission (FTC) does not send Warning Letters. If your claims are out of compliance, FTC is going to file a complaint.

Claims Substantiation: How to Ensure Your Dietary Supplement Product Claims are Truthful & Lega

Presented: March 3, 2006

The FDA and FTC have stepped up their enforcement activities against unlawful drug claims and unsubstantiated structure/function claims made by supplement marketers.

Federal Food Allergen Labeling & Consumer Protection Act Seminar

Presented: December 2, 2005

Targeted and instructional information to help you efficiently learn the relevant components of the law, become trained to set up a compliance program, and hear what is at stake if products do not meet the new policy.
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