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

Marketing Red Flags for Dietary Supplements

Presented: October 25, 2012

This webinar focuses on a number of regulatory compliance challenges that the dietary supplement industry encounters in its efforts to navigate regulatory compliance while creating successful product marketing campaigns.

cGMP Compliance Series Teleseminar: Variances

Presented: November 1, 2011

Variances--an exception or departure from approved protocol--occur and this webinar will help you prepare for them.

FDA's NDI Guidance: What You Need to Know

Presented: July 19, 2011

A panel of experts help attendees understand the key elements of FDA's New Dietary Ingedient (NDI) draft guidance and how it will impact businesses in the supplement industry.

Living with Proposition 65: Preventative Measures & Defending Against a 60-Day Notice

Presented: October 18, 2010

As much as 30% of the national sales of dietary supplements may be to California consumers - but companies that market in that state may encounter high penalties for non-compliance with a California law known as Proposition 65. The focus of this law for the supplement class has been on the warnings required for products that may inadvertently contain small amounts of heavy metals, such as arsenic, cadmium, and mercury, and especially lead.

Guidance for Addressing FDA cGMP Inspections of Dietary Supplement Facilities

Understand your rights and obligations when FDA conducts a cGMP inspection

This Guidance for Addressing FDA Inspections of Dietary Supplement Facilities has been prepared to assist AHPA members in understanding their rights and obligations when the U.S. Food and Drug Administration conducts an inspection of a facility in which dietary supplements or ingredients are manufactured, processed, packed or held. It provides descriptions and analyses of the current federal laws that are relevant to inspection of dietary supplement facilities and suggestions of how to prepare for and conduct inspections in a manner that fully complies with these laws.

cGMP Compliance Series: How to Conduct & Manage a FDA Inspection

Presented: July 30, 2009

This webinar covers the extent of FDA's authority during an inspection, so you know your rights.

cGMP Compliance Series: Record Keeping, Document Control & How to Write SOPs

Presented: May 28, 2009

Learn how to create, manage and control documents for good GMP practices, inspectors, auditors and safety.

CGMP Compliance Series: Setting and Meeting Specifications for Contaminants in Finished Products

Presented: January 22, 2009

Under the cGMP rule, it is the responsibility of the manufacturer to identify contaminants likely or certain to be present in or on components received and to establish limits to prevent adulteration of these components.

Sustainability & Crafting Responsible "Green" Marketing

Presented: September 18, 2008

An expert panel provide practical. first-hand knowledge and answer questions about sustainability and how to walk the walk in a “greenwashed” world.

Shelf Life Statements on Dietary Supplements

Presented: May 22, 2008

The new Good Manufacturing Practice regulations for dietary supplements require that manufacturers with shelf life statements on their labels have appropriate scientific substantiation
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