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

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

Recorded Nov. 30 and Dec. 14

This two-part webinar provides an update on the elements of current Good Manufacturing Practice (cGMP) regulations (21 CFR 111) that have been the primary focus of recent FDA inspections. Experts also provide strategies to respond to an FDA  483 in order to avoid a warning letter.

CA Prop 65: Regulatory, Compliance and Litigation Developments

An overview of the clear and reasonable warning regulation, including recent changes and amendments

Recorded July 25, 2017 -- Member cost: $199. Nonmember cost: $399.

NDI Notification Practical: How to Submit an NDI Notification Without Objection

Webinar will teach you how to successfully traverse the NDI notification process and avoid common pitfalls that can result in FDA objections

Recorded May 9, 2017 - Member cost: $199. Nonmember cost: $399.

Webinar Recording: Claims substantiation

Ensuring your dietary supplement claims are truthful, substantiated and will help sell your product

Recorded March 28, 2017 - Member cost: $199. Nonmember cost: $399.

Free Webinar: Considerations for Transitioning Perennial Production to Organic

Webinar is aimed at perennial fruit producers, but concepts may be applicable to perennial medicinal plant crop production

April 4, 2017 3:00 pm ET -- Duration: 1 hour

How to Become Compliant with FSMA’s FSVP

The Food Safety Modernization Act’s (FSMA) rule on Foreign Supplier Verification Program (FSVP) for importers impacts most AHPA members in some way

Recorded Feb. 28, 2017. Member cost: $199. Nonmember cost: $399.

FSMA Direct Impacts to Most AHPA Members

Regulatory experts provide a road map to FSMA understanding requirements and compliance

Webinar recorded Dec. 15, 2016. Member cost: $199. Nonmember cost: $499.

FDA Inspections, Warning Letters and Emerging cGMP Compliance Issues

Learn the elements of 21 CFR 111 / current Good Manufacturing Practice (cGMP) regulations that FDA inspections have been focusing on recently

Webinar recorded Dec. 13, 2016. Member cost: $199. Nonmember cost: $499.

California Prop 65 Webinar: A Status Update

Companies selling products in California should understand recent and developing Prop 65 changes

Recorded November 16, 2016. Member cost: $220. Nonmember cost: $520.

Free AHPA Webinar Examines Revised NDI Draft Guidance

Herbal industry experts provide analysis of 2016 Draft Guidance for New Dietary Ingredients (NDIs)

Recorded August 30, 2016. Member cost: Free. Nonmember cost: $99

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