GMP Training Overview
In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect for manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP requirements
Learning Objectives
The Good Manufacturing Practice Certificate Program provides a comprehensive overview on the best practices regarding the management of manufacturing and quality control testing for pharmaceutical products.
The Live Online Training is designed for people who have no or little knowledge of GMP.
- You get to know the most important pharmaceutical regulations and their importance.
- You get a basic overview of GMP requirements in pharmaceutical production.
- 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.
Course Content
- An Introduction to Good Manufacturing Practice (GMP),
- CFR Title 21, Parts 58, 210, 211 Overview
- GMP in the Warehouse,
- Quality Control Laboratory Design
- Microbiology in the Workplace,
- Cleaning and Sanitation,
- Good Documentation Practices - GMP Laboratory
- Documentation and Record Keeping, Stability & Training
- Contamination Control,
- Production Controls,
- Packaging Controls,
- Quality Assurance and Quality Control
- Pharmaceuticals Corrective Actions and Preventative Actions (CAPAs).
- The Regulatory Inspection
- Deviations / Non-conformances
- OOS / OOT
- How to write an effective investigation
Course Provider
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. 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.
Who Should Attend
This GMP Course will be valuable to all individuals working within or managing a GMP laboratory that supports either the R&D development of a new drug product or the testing and control of commercial drug products released to the market. Obtaining the certification would be beneficial to professionals in:
- Research and Development
- Quality Control
- Quality Assurance
- Technical Operations
- Contract Laboratories
- Regulatory affairs personnel as well as individuals who are responsible for the review or audit of such laboratory data and reports should likewise consider the value of this comprehensive certification in their positions.
