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  FDA cGMP Inspections & Emerging Compliance Issues for Dietary Supplements Teleseminar

February 23, 2012

Representatives from the Food and Drug Administration (FDA) have recently indicated that the most important issue for the dietary supplement industry is to comply with current good manufacturing practice (cGMP), and suppliers are challenged by having to come into compliance with a new rule that is essentially based on a drug GMP.
 
The American Herbal Products Association (AHPA) maintains the largest repository of inspection data from actual Form FDA 483s or "Inspectional Observations," establishment inspection reports (EIRs), and other sources and has created a detailed analysis of where FDA inspectors focus their attention during these inspections.


Presenters and Topics:


Anthony Young, Kleinfeld, Kaplan & Becker
Anthony Young has extensive expertise in all matters relating to the administration of the Federal Food, Drug, and Cosmetic Act and related laws. He represents food, drug, and dietary supplement product and ingredient manufacturers, developers, and distributors. Mr. Young has represented various trade associations before FDA, and he currently serves as general counsel to the American Herbal Products Association (AHPA). Mr. Young presented information on the following topics:

  • Inspection preparedness and what to expect during a cGMP inspection
  • Manufacturer vs. contract manufacturer vs. supplier vs. brand marketer: What are the differences and what aspects of the cGMP are you responsible for during an inspection?
  • Using and understanding available guidance

Marian Boardley, Marian Boardley Consulting

Marian Boardley is an independent consultant who manages cGMP projects for dietary supplement manufacturers and distributors. Ms. Boardley is also currently a senior consultant with FDA Compliance Group LLC. She advises several clients in the food, drug, and dietary supplement industries in cGMPs and legal compliance. She regularly trains staff to be ready for FDA inspections and also writes standard operating procedures in good manufacturing practices. Ms. Boardley recently spent over two years managing cGMP compliance and the botanical identity program for a Utah-based dietary supplement company. Ms. Boardley presented information on the following topics:

  • FDA Warning Letters and 483s: What they teach and how to respond, including general compliance stragegies for small-, mid-, and large-sized businesses

Merle Zimmermann, Ph.D., AHPA Information Analyst

Dr. Merle Zimmermann has been spearheading the collection and analysis of information on FDA inspections and related documentation for AHPA and is initimately familar with 21 CFR 111. A graduate of the University of Maryland with a doctorate in analytical chemistry, Dr. Zimmermann has been an invaluable addition to the AHPA staff and will be providing a detailed analysis of the FDA inspections. Dr. Zimmermann presented infomartion on the following topic:

  • Detailed analysis of recent FDA inspection reports, including a summary of the collection process, review of data, primary observations, and detailed examples.

Materials in this packet include:

  • Teleseminar presentation files
  • Teleseminar audio file

 

Member Price: $220.00

Non-Member Price: $520.00

 

 

 


  cGMP Compliance Series Teleseminar: Variances

November 1, 2011

Customer complaints, product returns, out-of-specification lab results, calibration failures, manufacturing deviations … all of these are serious issues no business in the dietary supplement industry wants to face. But variances--an exception or departure from approved protocol--occur and have to be prepared for and managed under dietary supplement cGMP. The cGMPs apply to all domestic and foreign companies that manufacture, package, label, or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distribution in the United States.

Under FDA regulations for cGMPs, variances must be detected, investigated, documented, explained, and addressed. With the right guidance, information, and tools, the process is much easier.

 

This AHPA educational teleseminar and accompanying standard operating procedure (SOP) templates (more than 30 are included) will assist dietary supplement marketers, manufacturers, distributors, and suppliers with a thorough understanding of the following key variance issues:

  • FDA regulations and how they apply to your business
  • A review of variance issues with practical guidance on how to address them from a panel of industry cGMP experts. Topics include:
    • Customer complaints and product returns
    • Out-of-specification investigations
    • Corrective and preventative actions
    • Product recalls
    • Reportable foods, recordkeeping, and SOPs

Materials in this packet include:

  • Teleseminar presentation files
  • Teleseminar audio file
  • More than 30 fully customizable examples of SOP reports and log forms, including:
    • Unplanned Events
    • Calibration Failures
    • Nonconforming Materials
    • Planned Deviations
    • Production Failure
    • Corrective & Preventative Actions
    • Out-of-specification Investigations
    • Customer Complaints
    • Returned Goods
    • Reportable Foods
    • Recall Procedure

 

Member Price: $220.00

Non-Member Price: $520.00

 

 

 


  cGMP Compliance Series: Adverse Event Reporting: Strategies for Compliance

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, which goes into effect December 2007 and requires dietary supplement manufacturers to file serious adverse event reports (AERs) with the Food and Drug Administration. In addition to reviewing the regulation and FDA’s guidance document, AHPA provides practical documents and insights from these expert speakers:

  • Anthony Young, Esq, of Kleinfeld, Kaplan & Becker LLP, and AHPA’s General Counsel — reviews your legal obligations under the new law, the Dietary Supplement and Nonprescription Drug Consumer Protection Act. In addition to reviewing FDA’s guidance document, he will also describe how the law differentiates a serious AER from an AER and a customer complaint and explain required reports and recordkeeping requirements.
  • Michael McGuffin,AHPA’s President — focuses on how companies should communicate with their customers and how to use the current MedWatch form.  He will also discuss the information needed to create a complete record of each report and add his insights into the FDA guidance.
  • Tieraona Low Dog, MD, Director of Education for the Program in Integrative Medicine at the University of Arizona, Clinical Assistant Professor in the Department of Medicine and a Clinical Lecturer for the University of Arizona College of Pharmacy —explains important considerations when recording adverse event history, including how to focus on the clinical course of the reported event, medical history, recording concomitant use of other medical products and other relevant medical information.

Questions they answer include:

  • How do we communicate AER information to our contracted manufacturer? Who should take those calls? Who should follow up afterwards?
  • Can we handle this task in-house, or do we need to contract someone?
  • Which MedWatch form should we use? None of them are really for dietary supplement or OTC products.
  • We don’t have doctors on staff, so how (and who) decides if an AER is serious?
  • How much should we follow-up after an adverse event is reported? 
  • Do we have to show our AER files to FDA during inspections? 
  • How can we get accurate information, and how much of their medical history is important?
  • What should we tell our health food store and practitioner clients? 

Support documents to help your company comply with the law include:

  • “AER vs. Customer Complaint” — a decision-making flow chart
  • Mandatory MedWatch form and facsimile MedWatch form
  • “Quick Glance Advice about Mandatory Reporting”
  • AHPA’s instructive form for recording information concerning an adverse event associated with dietary supplement product use


Member Price: $220.00

Non-Member Price: $520.00 

 

 


  cGMP Compliance: Botanical Identity & Herb Quality

September 28, 2006

How you handle botanical ingredient identity and quality is key to the products you’re manufacturing. Designed for companies that want to evaluate their ingredient identity and quality assurance systems, and prepare for new demands expected to be in FDA’s dietary supplement GMP rule. The materials from this AHPA educational tele-seminar will help you understand FDA’s proposed rules and how industry responded — giving you both the maximum and minimum expected standards that are on the horizon. Making Good Manufacturing Practice a part of your process sooner, rather than later, will ease the burden of compliance when final cGMP rules are issued.

What you’ll learn from these experts:

  • Lynda Hammons,Vice-present of Quality and Regulatory Affairs at Nature’s Sunshine Products — gives practical advice on setting and using standards, how to set ingredient specifications and select vendors, and shares a practical Raw Materials Testing Criteria Flow Chart
  • Sidney Sudberg, DC, LAc, RH (AHG), Director of Alkemists Pharmaceuticals, Inc. — explains Good Laboratory Practice, quality control, various analytical techniques for ingredient characterization and standardization, and case studies.
  • Roy Upton, RH (AHG), Executive Director of the American Herbal Pharmacopoeia, Vice-president of the American Herbalists Guild — reviews the legal requirements and expectations, and details physical tests (macroscopic characterization, microscopy), chemical tests (HPTLC, HPLC, FTIR, NIR), methods validation, documentation, sampling

Materials in this packet include:

  • A practical Raw Materials Testing Criteria Flow Chart
  • Course Outline, Speakers’ Presentations & Bios
  • Transcript, including answers to questions posed by attendees
  • Audio file

 

Member Price: $220.00

Non-Member Price: $520.00

 

 

 


  cGMP Compliance Series: Good Manufacturing Practices: The Final Rule

July 12, 2007

If you’ve started to read the new good manufacturing practice rules (cGMPs) for dietary supplements, you’ve already got questions. Chances are, AHPA has already answered them in this educational event that will help you learn exactly what you need to know about the new cGMPs, including the necessary processes and procedures to comply when they go into effect.

Course materials include AHPA’s Annotated Final Rule on Dietary Supplement cGMP, an easy-to-read document that presents key points and comments made by FDA in the preamble to the final rule next to the relevant sections. Speakers include the head of the Food and Drug Administration (FDA) dietary supplement program that wrote the new regulations as well as respected industry professionals who were deeply involved in reviewing and commenting on the cGMPs when they were proposed in 2003. 

Speakers:

  • Vasilios H. Frankos, MS, PhD, director of Division of Dietary Supplement Programs in the FDA's Center for Food Safety and Applied Nutrition — responsible for the full implementation of the DSHEA Act of 1994, Dr. Frankos directs and coordinates policy and administrative activities within the Division. Dr. Frankos advises on policy and management issues on dietary supplement programs, new dietary ingredient safety assessments, good manufacturing practice, adverse reaction monitoring, and related activities pertaining to dietary supplements.
  • Marc Ullman, Esq, partner with the law firm of Ullman, Shapiro & Ullman — specializing in food, drug, and cosmetic law, he also provides legal services to his clients in many other areas, including litigation support and trademark/copyright matters. Mr. Ullman’s practice includes representation relating to FDA compliance — including labels, labeling, claims, good manufacturing practices, and adversarial proceedings relating to the scope of the agency’s powers under DSHEA.
  • Michael McGuffin, president of the American Herbal Products Association — Active in the supplement industry since 1975, having owned both retail and manufacturing businesses, Mr. McGuffin has been AHPA’s president since 1999. He has represented the herbal industry at state and federal hearings on herbal regulatory issues and as a member of various FDA’s Food Advisory Committee Working Group on Good Manufacturing Practices for Dietary Supplements, and the Dietary Supplements Subcommittee of the FDA’s Food Advisory Committee.
  • Event Facilitator: Tony Young, Esq, partner with the law firm of Kleinfeld, Kaplan & Becker

     

Materials include:

  • AHPA’s Annotated Final Rule on Dietary Supplement cGMP
  • Copies of the cGMP rules as published in 2003 and 2007
  • Comparison of current good manufacturing practice regulations
  • Presentations from all speakers
  • Written transcript, including answers to questions posed by attendees that were not addressed during the event for lack of time
  • Course Outline & Speakers Bios
  • NO Audio file is available for this seminar. We sincerely apologize for any inconveniences.
  •  

    Member Price: $220.00

    Non-Member Price: $520.00

     

     

 


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

July 30, 2009
For many companies who have never been through an FDA inspection these may not only be new questions but likely nerve-racking ones as well. Wouldn't you like to have more than "some idea" of the authority the FDA has during an inspection, so you know what your rights are? As of June 25, 2009, the dietary supplement cGMPs are now in effect for those companies with 20 or more employees. This means that your facility could be subject to an FDA inspection AT ANY TIME, if you fall into this category. You should know what your rights are, what authority the inspectors have, and enable your staff to better understand the process and feel confident throughout it. This seminar will be an invaluable opportunity for you and your company to gain insight and practical information in a cost effective manner (with no travel costs!).

Take advantage of the expertise of these speakers:

  • Staci Eisner, regulatory affairs, quality assurance, research and development, and facility design for ExtractsPlus/PlusPharma, Quality and Regulatory Affairs Manager, Botanica Bioscience
  • Jim Prochnow, Esq, Greenberg Traurig, Adjunct Professor of Law at the University of Denver Law School
  • Steven Shapiro, Esq, Ullman, Shapiro & Ullman, LLP
  • Robert Ullman, Esq, Ullman, Shapiro & Ullman, LLP
  • Anthony L. Young, Esq, Kleinfeld, Kaplan and Becker, LLP
  • Mary Beth Watkins, BS, MS, Director of Quality and Compliance for Botanical Laboratories, Inc.

Materials in this packet include:

  • Course Outline, Speaker Bios
  • Transcripts to the two duplicate sessions, and answers to questions posed by attendees
  • Audio file


Related materials include (can be purchased separately):

 

Member Price: $220.00

Non-Member Price: $520.00 

 

 


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

May 28, 2009

Whether your company is already required to be compliant with the GMP rules, or if you're due to be in compliance on June 25, 2009 or 2010, this seminar will benefit your company and its employees. Documents tell the true story of compliance. Without good documents and document control all of your GMP efforts may count for nothing. Learn how to create, manage and control documents for good GMP practices, inspectors, auditors and safety. Topics that will covered include: the role of the documentation manager/document control manager, general documentation practices, writing documents & SOPs - details on components and how to, record keeping strategies, worksheets vs. logbooks, document change control, training records, record retention, purging and destruction and FDA Inspections.

Course materials include:

  • Audio file of the AHPA event
  • An unedited transcript of the AHPA event

 

Member Price: $220.00

Non-Member Price: $520.00

 

 


  cGMP Compliance Series: The Quality Unit

December 14, 2006

As described in the proposed 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. The Quality Unit touches on nearly all manufacturing processes, from setting ingredient standards to ensuring they are met, qualifying third-party testing labs, packaging components and labeling, practical cost considerations and finished product quality.

This GMP compliance seminar focuses on establishing your company’s Quality Unit by outlining its responsibilities and roles, and offers practical insights from experienced experts. 

What you’ll learn from these experts to set up your company’s Quality unit efficiently and economically:

  • Warren Majerus, MS, Quality Systems Implementation, Inc., President — With nearly 30 years of experience in product development and Quality Control in food and supplement processing and analytical methods, Mr. Majerus is experienced in DSHEA- and CFR 110-based compliance auditing worldwide. He focuses on Auditor/Manufacturer/QC considerations, which include your Quality Unit’s scope of responsibility and authority, how to establish written specifications for materials and processes, and those specifications’ purpose and basis.
  • Daniel Stephens, MBA, Herb Pharm, Quality Control & Laboratory Services Manager — Involved in quality control and food safety compliance for nearly 30 years, Mr. Stephens has instituted and managed HACCP and ISO systems and audited quality assurance methods for production facilities, retail stores, storage sites and distribution centers. He shares his insights on industry/practical Considerations that the Quality Unit must address, including packaging components, raw materials, labeling, third party testing lab qualification, and finished products.
  • Anthony Young, Esq, General Counsel, American Herbal Products Association, partner with the law firm Kleinfeld, Kaplan and Becker, LLP — Practicing food, drug and environmental law since 1974, Mr. Young advises and represents domestic and foreign manufacturers with respect to compliance and defense of matters under the statutes enforced by the FDA, FTC, DEA, EPA, and more. He discusses the importance of the Quality Unit and legal liabilities.

If you haven’t started down this road, these speakers will provide solutions. And if your company already has a Quality Unit in place, these AHPA materials will help you identify new efficiencies or areas that need more resources.

Materials include:

  • The proposed cGMP regulation that clearly outlines the Quality Unit requirements
  • Presentations by Warren Majerus and Dan Stephens, with several supporting documents for each
  • Transcript, including answers to questions posed by attendees
  • Course Outline & Speakers Bios
  • Audio file

 

 

Member Price: $220.00

Non-Member Price: $520.00

 

 


  Debriefing the FDA's cGMP Implementation Seminar
October 25, 2007

In October 2007, four months after publishing the current good manufacturing practice (cGMP) regulations for dietary supplements in June, the Food and Drug Administration held a multi-media educational event for stakeholders, Overview of the Implementation of the Current Good Manufacturing Practices for Dietary Supplements Guidance for Industry. During that event, FDA gave some interesting and sometimes surprising insight into how they intend to implement the new cGMP rules. AHPA was ready the very next day with this debriefing that offers expertise to answer specific questions and dispel any confusion that arose from the FDA overview. This important event offers the insight you need to comply with the regs and stay in business! 

AHPA understands that the cGMPs will affect your business in many ways, and that some of these regulations are complicated. To ensure you have the knowledge and tools to comply, AHPA offers its expertise to answer specific questions. In order to comply and stay in business, learn from AHPA President Michael McGuffin and AHPA’s general counsel, Tony Young, Esq.

  • Both have closely scrutinized the GMPs throughout their development, understanding their practical applications and legal details and providing comments on behalf of industry to shape their final form.
  • Both have also participated in AHPA’s ongoing series of educational tele-seminars on GMPs.
  • McGuffin authored AHPA’s Annotated Final Rule on Dietary Supplement cGMP, which links key points and comments found in FDA’s lengthy preamble to the final GMP rule to each specific section of 21 CFR 111 to which it applies.

Course materials include:

  • Audio file of the AHPA event
  • An unedited transcript of the AHPA event
  • Links to FDA’s archived webcast

 


Member Price: $220.00

Non-Member Price: $520.00

 

 

 

 

 



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