Who doesn’t want their business or product manufacturing unit to function with great performance? What if you could be the star manager of these units?
This 4 Half-day long GMP training will equip you to increase your efficiency and strengthen your skills for a stellar career in the industry. Whether you want to level up your designation or become an entrepreneur, the credibility of a GMP course will only add stars to your portfolio.
Course Overview
For any professional working in the laboratory, it is essential to know the basic regulations and code of conduct. Good manufacturing practices comprise these regulations associated with every aspect at an operational level.
The GMP training stretched over 4 Half days is curated in a beginner-friendly format. Here are some takeaways from the GMP training for employees:
- Basic regulatory norms and their benefits
- GMP in the pharmaceutical industry
- Makes the candidate familiar with technical terms and their relevance
- Training for QC labs
- Clarification on techniques to adhere to the regulations
- Norms related to design and utilities
- Good laboratory practices including equipment and instrumentation norms
Furthermore, a detailed list of topics discussed in the GMP training for the pharmaceutical industry includes:
- 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
- Pharmaceutical’s 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
To further clarify the relevance of GMP training for employees, here is a list of benefits you can get from this course:
- R&D Associates and Research Scholars: Helps you understand the basic laboratory norms and pass the quality inspection with the best ratings.
- Technical Experts in Operations: Makes you thorough with production facility protocols, equipment, tools, and machines. This guarantees better execution of technical knowledge by adhering to standard norms.
- Contract Laboratories: Empowers lab technicians with the knowledge of handling and storage of raw materials, sanitation and hygiene, quality control, and structuring of the lab.
- Regulatory affairs personnel: Gives you a standard manual to audit or investigate the laboratories and production units. Furthermore, allows you to conduct a thorough inspection at reputed laboratories.
