GMP for QC Laboratory Compliance
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.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect of manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP requirements.
The Good Manufacturing Practice Program provides a comprehensive overview of the best practices regarding the management of manufacturing and quality control testing for pharmaceutical products.
- You get to know the most important pharmaceutical regulations and their importance
- You get a basic overview of GMP requirements in pharmaceutical production, and
- You become familiar with technical terms from the field of GMP and their meaning
- Understand the regulatory requirements governing GMP-compliant QC Labs
- Understand how to apply those requirements
- Understand the regulatory expectations regarding laboratory design and utilities
- Understand the regulatory expectations regarding laboratory equipment/instrumentation
Who Should Attend
- Analytical Development
- Quality Assurance
- Quality Control
- Regulatory Affairs