FDA Regulations for Pharmaceutical Current Good Manufacturing Practice (cGMP) webinar

  • Instructor : Dr. Loren Gelber
  • Level : Intermediate
  • Study time : 105 minutes
  • Course ID: TF2951
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ABOUT THE COURSE

Are your manufacturing practices fully aligned with current FDA cGMP expectations?
Do you know which cGMP missteps most commonly lead to Warning Letters?
Is your team getting the right level of training to stay compliant year after year?


This training isn’t just a regulatory checklist—it’s your chance to build real-world clarity around cGMP expectations using FDA case examples that show you what to do, and what to never do.


WHAT WILL YOU GAIN
  • Working knowledge of every core section of the FDA cGMP regulations
  • Lessons drawn directly from Warning Letters and inspection outcomes
  • Insight you can use for both onboarding and annual GMP refresher training


WHY TAKE THIS COURSE
  • Get every team member—new or experienced—up to speed on cGMP
  • Train with examples drawn from real FDA enforcement cases
  • Strengthen internal compliance culture and reduce audit risk


KEY AREAS COVERED
  • Foundational overview of Current Good Manufacturing Practice (cGMP)
  • Detailed walkthrough of each section of FDA’s cGMP regulation
  • Real-life examples from FDA Warning Letters and 483 observations
  • Common GMP violations and what they reveal about gaps in training
  • Strategies to ensure compliance across manufacturing and packaging
  • Best practices for onboarding and annual GMP refresher programs

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

Dr. LOREN GELBER

With 40+ years in pharma compliance and a decade at the FDA, Dr. Loren Gelber brings unmatched clarity to cGMP regulations. Her background spans drug review, inspections, and consulting across the industry—making her the ideal guide for anyone serious about getting GMP right. From new hires to seasoned professionals, she’s trained them all—and knows exactly where most go wrong.

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