Ensuring Regulatory Compliance of GMP Laboratories
April 23, 2019
This one-day intensive program will discuss FDA’s current Good Manufacturing Practice (GMP) requirements for Research and Development and Quality Control Laboratories. The course will cover GMP regulations for physical, analytical, and microbiological laboratories including analyst training and qualification; the labs’ physical facility and environment; instrument qualification, calibration and maintenance programs; laboratory sample control processes; the management of standards and chemicals; the management of data; and overall laboratory documentation. The development, verification, validation, control, and use of test methods as well as transfer thereof will also be discussed. An entire session will be dedicated to the performance of thorough, timely, unbiased, well-documented, and scientifically sound Out-of-Specification (OOS) investigations since this is one of the most critical laboratories quality systems. Tips regarding establishing quality agreements with clients and handling the FDA during an inspection will also be provided.
FDA issues of concern will be highlighted throughout the program with emphasis placed on recent FDA regulatory or administrative actions. All of this will allow participants to gain an understanding of the importance of laboratory GMPs and how to meet FDA’s requirements.
Dates and Location
April 23, 2019
Hilton Garden Inn Denver Downtown
1400 Welton St.
Denver, CO 80202
Group Rate, two or more from the same firm – 10% per person (GROUP10)
Federal/State Government Employees – 10% per person (GOV10)
Registrants with Promotion codes - Limit one Promotion code per transaction
- Training manual with the slide presentation
Tara Lin Couch, Ph.D., Senior Director, Dietary Supplement and Tobacco Services
Dr. Couch is a Ph.D. Analytical / Organic Chemist with over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She possesses exceptional analytical abilities as demonstrated also by her B.S. in Mathematics. She has served as the Study Director on numerous EPA and clinical studies as well as directed the Quality Control department at a pharmaceutical and dietary supplement manufacturing facility. The latter entailed directing all aspects of the quality control analytical and microbiological laboratories including management of the company Stability Program and Quarantine Area operations. Dr. Couch also provided scientific expertise and technical support for new product development, product reformulations, and on-going production challenges. She served as the scientific head of a Strength and Purity Verification Testing Program committee, which provided full label claim testing on dietary supplements to meet all Dietary Supplement Health and Education Act (DSHEA) regulations and expectations of the FDA. Her talents were also utilized to evaluate and set raw material and finished product specifications and prepare product summaries (white papers) for dietary supplement products.
As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical and compliant with all FDA regulations. She is an experienced speaker having presented numerous scientific and regulatory compliance lectures around the country, conducted in-house and external Dietary Supplement GMP trainings, and taught entry level to graduate level chemistry courses and laboratories at several academic institutions.
Who Should Attend?
This program would benefit individuals involved in the Regulatory Affairs, Quality Control/Quality Assurance, Manufacturing, Research & Development, Validation/Qualification, laboratory analysts, supervisors, and managers. It will be of particular interest to those charged with implementing, validating and maintaining laboratory compliance programs.
Minimum Registration Policy
- Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel within 45 days of the training and refund the registration fee in full.
- Cancellations received before 46 days prior to the training event 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 notice is given to EAS in advance.
For More Information
- Contact Amy Scanlin at (571) 447-5508 or email@example.com