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
March 19-20, 2009*
EAS Consulting Group - Training Facility
1940 Duke Street, Suite 200
Alexandria, VA 22314
*Held in conjunction with: Dietary Supplement GMP Seminar, a 2-day seminar held on March 17-18, 2009
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.
WHO SHOULD ATTEND?
- Laboratory analysts performing component, in-process material, finished product, and stability testing
- Laboratory supervisors and managers
Quality assurance/quality control managers, supervisors, and auditors of in-house and contract laboratories
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)
- Introduction and Objectives
- Laboratory Regulatory Compliance: Understanding the Key Control Elements
- Testing Ingredients and Products: Specifications, Testing Schemes, Certificates of Analysis, Supplier Qualification
- Lab Physical Facility and CGMPs
- Lab Personnel: Analyst Training/Qualification Programs; Staffing
- Ensuring and Demonstrating Analytical Instrument and Computer Software Performance
- Representative and Reserve Samples; Sampling Plans
- Reference Standards, Reagents, Solutions
- Expiration Dating: Developing a Credible Stability Testing Program
- Work Session I: Case Studies (Ends 4:30 pm)
Day 2 – (Starts 8:00 am)
- Laboratory Documentation: A Key to Good Science and CGMP Compliance
- Analytical Methods: Development, Validation, Transfer, Change
- Contracting of Laboratory Services: Regulatory Implications and Other Considerations
- Written Procedures, Change Control, QC Oversight
- Conducting Material Reviews
- Work Session II: Case Studies
- Final Questions, Evaluations, Wrap-Up (Ends 3:15 pm)
SEMINAR HANDOUTS
- Participant’s Manual (with copies of all seminar slides)
- Pocket Guide: 21 CFR Part 111
REGISTRATION INFORMATION
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.
AREA HOTELS
The seminar is being held within an easy walk of the King Street Metro Stop (a 7 minute ride from Reagan National Airport) in historic Old Town Alexandria, VA. There are many hotels and restaurants to select from. Hotels in the immediate area include:
Westin Alexandria
400 Courthouse Square
Alexandria, VA 22314
703-253-8600
New hotel (opened October 2007) within 1 block of EAS headquarters.
Old Town/King Street Hampton Inn
1616 King Street
Alexandria, VA 22314
703-299-9900
One block from King Street Metro; two blocks from EAS headquarters.
Ask for “EAS Consulting” preferred rate - $189.
Embassy Suites Alexandra – Old Town
1900 Diagonal Road
Alexandria, VA 22314
703-684-5900
Directly across the street from the King Street Metro stop/EAS headquarters.
Hilton Alexandria Old Town
1767 King Street
Alexandria, VA 22314
703-837-0440
Directly across the street from the King Street Metro stop; one block from EAS headquarters.
Residence Inn by Marriott
1456 Duke Street
Alexandria, VA 22314
703-548-5474
Four blocks from the King Street Metro stop; three blocks from EAS headquarters.
Courtyard by Marriott
2700 Eisenhower Ave.
Alexandria, VA 22314
703-329-2323
Two blocks from Eisenhower Metro stop (one stop from EAS headquarters at King Street) or long walk.
Holiday Inn – Eisenhower Metro
2460 Eisenhower Avenue
Alexandria, VA 22314
One block from Eisenhower Metro stop (one stop from EAS headquarters at King Street) or long walk.
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 Ed Steele at 703-684-4408 esteele@easconsultinggroup.com
