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Online GMP Courses: GMP training

  • This course includes17 hours on-demand streaming.
  • Access on all mobile and Computer Devices
  • 1 year on demand access
  • Certificate of completion with 17 RAC credits

Our GMP training online courses enable instant access to Good Manufacturing Practice (GMP) Certificate Courses for GMP education programs. With a large variety of GMP education topics, complete with Certificates for your GMP personnel training records, GMP training (online) is a great addition to your internal Industry Training & Development programs.

Available 24/7 via the internet, and taking just 1 to 4 hours each, these eLearning modules are perfect for busy professionals who work in the life sciences sector (e.g., the pharmaceutical industry, medical device manufacturing industry, or veterinary medicines sectors).

How to Earn Your GMP Certification?

Becoming a attendee is easy.

  • Enrol: Register for the complete 17 hrs course program. You will receive an email with instructions on accessing the courses.
  • Earn: Once you have fulfilled all the program requirements, you will receive a certificate recognizing your achievement.
Training #1 GMP master class – get it right to avoid compliance issues (12 hrs)


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)


  • 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:


  • Auditing API facilities
  • Typical audit agenda
  • ICH Area differences

Finished Products

  • Auditing finished product facilities
  • Typical audit agenda
  • ICH Area differences


Sterile products


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