May 02 - 03, 2024 | US Eastern Time: 9 AM to 2 PM | Central Europe Time: 3 PM to 8 PM
Ensuring compliance with FDA regulations is crucial for companies operating in industries such as pharmaceuticals, biologics, medical devices, foods, and cosmetics. The FDA conducts inspections and oversees quality control (QC) laboratories to evaluate compliance status, and non-compliance can result in serious consequences such as regulatory actions, hefty fines, and even criminal charges.
This course offers comprehensive training on the essential requirements for all QC laboratories subject to FDA inspection. Participants will learn about recent trends in FDA inspection reports and enforcement actions, as well as relevant regulations and guidelines. Quality control and quality assurance personnel will also learn how to monitor industry practices to stay up-to-date with FDA requirements, including cGMPs and GLPs. Enroll in this course to ensure your QC laboratory is compliant and avoid costly consequences.
|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 (9 AM to 2 PM)Understanding FDA law and regulations for QC laboratories
What is adulteration?
Documentation and record-keeping requirements
DAY 2 (9 AM to 2 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.