Ensuring Regulatory Compliance of Dietary Supplement Laboratories

FDA’s Final Rule on Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements places significant emphasis and responsibilities on the dietary supplement laboratory and QC personnel. The laboratory is a cornerstone for ensuring the quality of products marketed by dietary supplement manufacturers. FDA focuses on laboratory controls during inspections to ensure that analytical results are credible and the laboratory is CGMP compliant. FDA trend data over the past several years shows that deficiencies in laboratory controls are consistently one of the most frequently cited observations during inspections of pharmaceutical companies.

This two day course will provide you with the knowledge and skills for evaluating, auditing, managing, and improving the CGMP compliance of your in-house and/or contract laboratory. You will gain knowledge for identifying and closing CGMP gaps and implementing the 15 key laboratory quality systems. You will be provided with examples of lab CGMP deficiencies from FDA-483 drug citations and recommendations for practices and procedures to ensure and demonstrate CGMP compliance with the Final Rule.

DATE AND LOCATION

October 8-9, 2009 Canceled

EAS Consulting Group - Training Facility
1940 Duke Street, Suite 200
Alexandria, VA 22314

IN-HOUSE SEMINARS

EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost effective alternative to train your employees. It also allows the program to be tailored to your particular needs.

Contact Ed Steele for a price quote. 703-684-4408

INSTRUCTOR

William Ment
William Ment has 34 years of experience in FDA field laboratories, serving as a chemist, research coordinator, laboratory management/research/quality systems coordinator, supervisor, and director. In his last position, Mr. Ment was the Laboratory Director in Baltimore, MD, where he managed a staff of over 50 professionals having responsibility for the full range of FDA field lab sample analyses and research studies. Since May 1999, he has served as a Senior Consultant for the AAC/Kendle. In 2007 he joined EAS Consulting Group as a contract consultant specializing in pharmaceutical/dietary supplement laboratory cGMP audits, method validation/New Drug Application/Drug Master File reviews, and improving QA/QC operations, structures, and quality systems management. He has also trained industry personnel on FDA’s Proposed and Final Rules for dietary supplement cGMPs at national seminars and on-site at the firm’s facility.

Robert Fish

Robert Fish has been providing independent consulting services since 2003, joining EAS Consulting Group, LLC in November 2006. Prior to that, he worked for AAC Consulting Group, Inc. (AAC) for 9 years and with the Food and Drug Administration (FDA) for 33 years. The last 6 years of FDA service he held the position of Director, Division of Field Investigations (DFI). There he was responsible for general policy and guidance for the AgencyÕs domestic and international investigation activities. He also managed the foreign inspections' operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office for 8 years and was also a Supervisory Investigator at the Nashville District Office for 8 years. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962, and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to dietary supplements, pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor.

WHO SHOULD ATTEND?

SEMINAR AGENDA

This training will provide an overview of the regulatory requirements of the Final Rule as it pertains to dietary supplement laboratories, which will be augmented with statements from the Final Rule Preamble, comparison to Proposed Rule requirements, the presenter’s own FDA and auditing experience, and application to case study scenarios. The information-rich agenda includes the following topics:

Day 1 (Starts 8:00 am)

Day 2 – (Starts 8:00 am)

SEMINAR HANDOUTS

REGISTRATION INFORMATION

REGISTRATION FORM 

REGISTRATION FEE:

Ensuring Compliance of Dietary Supplement Laboratories Seminar $1,200

DISCOUNTS:

Registrants with Promotion codes - Limit one Promotion code per transaction
Group Rate (two or more from same firm) - 10% per person
Federal/State Government Employees - 50% per person

METHOD OF PAYMENT:

Check or credit card payments are accepted.

MINIMUM REGISTRATION POLICY

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by September 22, 2009, and refund the registration fee in full.

CANCELLATION POLICY:

Cancellations received two weeks before each seminar will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as prior notice is given to EAS.

FOR MORE INFORMATION:

Contact Cathryn Sacra 703-684-4438 csacra@easconsultinggroup.com

Register Today!
Register Now