Good Manufacturing Practices (GMP)
Accredited Good Manufacturing Practices (GMP) trainings designed for life sciences. Get your individual GMP certification now!
Duration – 17 Hours | Instructor-led Interactive Training
Below courses are included in GMP Online Courses for Professionals and Beginners
Good Manufacturing Practices (GMP) Training Bundle
Accredited Good Manufacturing Practices (GMP) trainings designed for life sciences. Get your individual GMP certification now !
🌐 Flexible GMP Training – Learn Anytime, Anywhere
Our online GMP training courses provide instant access to industry-relevant Good Manufacturing Practice (GMP) certification programs, designed to support both individual professionals and corporate training needs.
With a wide range of GMP topics, each course is structured to strengthen your compliance knowledge, inspection readiness, and practical application, while also supporting your organization’s training and development initiatives.
⏱️ Designed for Busy Life Sciences Professionals
These self-paced eLearning modules are available 24/7 and can be completed in short, manageable sessions (1–4 hours each), making them ideal for professionals working in:
- Pharmaceutical Industry
- Biotech & Life Sciences
- Medical Device Manufacturing
- Veterinary Medicines
👉 Learn at your own pace—without disrupting your work schedule.
🎓 How to Earn Your GMP Certification
Getting certified is simple:
Step 1: Enroll
Register for the complete 17-hour GMP training program. You will receive an email with access instructions.
Step 2: Complete the Training
Go through all modules at your convenience within the access period.
Step 3: Get Certified
Receive your Certificate of Completion with 17 Continuing Education Credits upon successful completion.
📦 What’s Included in the GMP Training Bundle
- ✔️ 17 Hours of On-Demand Training Content
- ✔️ 4 Comprehensive GMP Courses
- ✔️ 1-Year Unlimited Access
- ✔️ Accessible on Mobile & Desktop Devices
- ✔️ Industry-Recognized Certificate (17 Continuing Education Credits)
🚀 Why This Training Works
- Practical, real-world GMP application
- Focus on FDA inspection readiness & compliance
- Flexible learning format for working professionals
- Ideal for both individuals and corporate teams
Training #1 GMP master class – get it right to avoid compliance issues (12 hrs)
Agenda
GMPs – Government Regulations
- What are the regulations governing Good Manufacturing Practices?
- Your responsibilities
- Pertinent GMP topics as per the code of Federal Regulations
- Quality Management
- Personnel
- Premises and equipment
- Documentation
- Production
- Quality Assurance
- Materials management
- Production and in-process controls
- Packaging and labeling
- Storage and distribution
- Laboratory controls
- Validation
- Change control
- Rejection and re-use of material
- Complaints and recalls
- Supplier controls
GMP Inspections
- Preparing for a GMP Inspection
- The consequences of not being ready
- The specific areas that are inspected during a GMP inspection
FDA Inspection Tips and Recommendations
- The FDA Inspection – how is it structured and conducted
- Responding and organizing for the FDA Inspection
- Importance of truthfulness
- Importance of knowledgeability and confidence
- FDA Tricks to elicit information
- Arguing and challenging
- Behavior during the inspection
- Importance and role of documentation
- Effective communication skills
- Being deceptive
- Opinion versus fact
- Phrases never to say
- Handling adverse findings during the inspection
Training #2 GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations (1.5 hrs)
Agenda
- FDA Guidance and Standards
- Major Misconception
- Overview of each regulation – GCP, GLP, GMP
- How each regulation is the same
- How each regulation differs
- FDA’s interpretation of each regulation
- Regulations and Requirements for each
Training #3 cGMP Training on FDA Inspections
Session 1:
U.S., EU, and Japan GMPs - Status of Harmonization& Future Trends
- Current status of harmonization of GMP requirements
- Future Trends
Where Inconsistencies Become a Problem: WHO, ICH, Countries
- Discrepancies in global expectations
- Alignment issues
Key Chapter Reviews
- ICH GMP organization
- Category reviews
Compliance with ICH Guidelines for GMPs
- Understanding and Insight into Healthcare Authority expectations
- How GMP requirements/inspections can differ from a single ICH Standard
- How regulators (from 3 regions) will assess/enforce compliance with Q7
Session 2:
APIs
- Auditing API facilities
- Typical audit agenda
- ICH Area differences
Finished Products
- Auditing finished product facilities
- Typical audit agenda
- ICH Area differences
Excipients
Sterile products
Biologics
Clinical Packaging
Session 3:
Area GMP Inspections
- Differences in how GMP inspections are conducted.
- Areas of GMP inspection focus by area
- Modifying your self-inspection systems to customized area concerns.
Outsourcing Management Regional Perspective on:
- Contract Manufacturing
- Contract packaging.
- 3rd Party Contract testing
Auditing Your Facilities for Global Considerations
- Importance of pre-audits to regional GMP focus.
- How to focus your internal audits on a US, EU, and Japan compliance system
Training #4 GMPs for MICROBIOLOGISTS — The Manufacturing Environment Webinar
To Gain an overall review of cGMP and those sections of 21 CFR 211 that impact microbiology within the Manufacturing environment
- Review USP, 21 CFR 211, EP, Canadian, ISO and various FDA Guidances that impact microbiological issues throughout the cGMP environment for the microbiologist within manufacturing/QC operations
- Determine how to control numbers/species of microorganisms within the manufacturing environment with disinfectants and antiseptics USP<1072>
- Review how to control water systems (PW/WFI) within a manufacturing environment
- Study how OOT, OOS and CAPAs impact all aspects of the microbiological environment
- Review various Case Studies that involve Form FDA 483s and Warning Letters
