OCTOBER 12 - 13 | KELLY THOMAS
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.
This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).
|SEMINAR OBJECTIVES||WHO SHOULD ATTEND|
|Senior directors, managers, supervisors and those who have responsibility for ensuring that QC laboratory operations and practices comply with current good manufacturing practices and good laboratory practices.|
- Quality Assurance Personnel
- Quality Control Personnel
- Research and Development Personnel
- Regulatory Affairs Personnel
- Project Managers
- Manufacturing Managers
- Validation Engineers
- Internal Auditing Personnel
- Microbiology Personnel
DAY 1 (10 AM to 3 PM)Understanding FDA law and regulations for QC laboratories
What is adulteration?
Documentation and record-keeping requirements
DAY 2 (10 AM to 3 PM)Documentation (contd.)
Stability (shelf-life) studies
Management and Control
Management and control of laboratory instruments
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.