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GMP Compliance for Quality Control and Laboratory Operations Course Description
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 is not a clickbait!
Our 2 Half-days 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.
Read on to know the topics we cover in our GMP training for employees!
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.
Our GMP training stretched over 2 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 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
If you are curious to know how this training is relevant to you, the following section will include the details.
Who will benefit from the course?
GMP training by World Compliance Seminars is designed to suit students and professionals at all levels. Even if you are an undergraduate looking for GMP certification online, our GMP course is the solution.
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.
People Also Ask
Q1 Are there types in GMP?
Yes. GMP training covers two types of GMPs i.e. general GMP and specific GMP (product specific). The former is all about general handling, hygiene, and safety of the procedures. On the other hand, the latter covers specific manufacturing protocols for the products.
Q2 Why is GMP training essential for brands and reputed companies?
A GMP course allows professionals to maintain consistency in the quality of the products. Furthermore, the training ensures you deliver high-quality, safe, and suitable protocols for the manufacturing of the goods. These are essential for setting up new production units and help in creating SOPs for the same.
Q3 Does GMP training help in finding loopholes in the process?
Yes. Having a sound knowledge of GMP allows you to strengthen overall management, track data, eliminate risks and errors, and reduce the frequency of non-standard products.
This live training Seminar includes the following for each registered attendee:
- A copy of the presentation slides by download
- A certificate of participation for attendee training records
- Q/A Session
- Free Handouts on FDA Inspection
How to Attend:
All WCS Seminar live training programs audio and visuals are delivered via Go to Seminar with a basic system requirement of a computer with internet access. You do not require a Go to Seminar account to join WCS Seminar live training courses, participants receive an email invitation that provides the access you need to join the meeting.
Know Your Faculty
Kelly Thomas, Head Of Quality Assurance (USA)
Highly experienced Quality Assurance / Quality Control / Regulatory Compliance leader with experience in API, biologics / biotech, both aseptic and terminally sterilized manufacturing processes, medical devices, drug / device combination products, and all pharmaceutical dosages (Sterile Injectable, OSD, Controlled Substances, Aerosols).
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.
