ICH Q7 GMP for Active Pharmaceutical Ingredients

  • Instructor : John E. Lincoln
  • Level : Intermediate
  • Study time : 99 minutes
  • Course ID: TF3785
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ABOUT THE COURSE

Are your API practices aligned with ICH Q7 expectations?
Facing challenges with GMP documentation and system controls?
Want a sharper grip on compliance before the next inspection?


This course helps you apply ICH Q7 practically ”from plant setup to product release,” so every process meets global expectations with zero guesswork.


WHAT WILL YOU GAIN
  • Clear roadmap for implementing ICH Q7 for APIs
  • Smarter documentation and quality control strategies
  • Confidence in facing FDA or international inspections


WHY TAKE THIS COURSE
  • Make ICH Q7 work for your systems, not against them
  • Avoid regulatory gaps that often go unnoticed
  • Train your teams on the real-world implementation of GMP


KEY AREAS COVERED
  • QMS foundation: ISO 9001 & ICH Q7 overlap
  • Documentation, validation, and quality release systems
  • Physical plant, personnel, and materials control
  • Manufacturing, lab, and post-production activities
  • Handling complaints and rejected materials
  • API-specific GMP nuances across global guidelines

Quality training, expert insights, and answers that matter. Know your Expert

JOHN E. LINCOLN

John E. Lincoln has guided companies through every step of the FDA submission journey from 510(k)s and PMAs to IDE filings. He's renowned for helping teams make the right submission choice, document it thoroughly, and align with the latest regulatory shifts. His deep expertise spans software compliance, risk strategy, and navigating IRBs and De Novo provisions. As an industry author, consultant, and educator, John delivers submission clarity that saves companies time, money, and stress.

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