Toxic Impurities in Active Pharmaceutical Ingredients webinar

  • Instructor : Dr. Loren Gelber
  • Level : Intermediate
  • Study time : 71 minutes
  • Course ID: TF2954
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ABOUT THE COURSE

Are you confident your API manufacturing is free of trace carcinogenic impurities?
Do you know what led to the nitrosamine-triggered recalls of sartans?
Would your impurity control program hold up against current FDA and EMA expectations?


If you’re involved in API development, cleaning validation, or regulatory compliance—this session delivers the real-world insight you need to stay ahead of the next nitrosamine disaster.


WHAT WILL YOU GAIN
  • Clarity on how toxic impurities like NDMA and NMBA are formed—and how to stop them
  • Strategies to manage trace analysis and meet global regulatory expectations
  • Insights into EMA and FDA stances on nitrosamines that could affect your next filing


WHY TAKE THIS COURSE
  • Prevent your product from ending up on a recall list
  • Strengthen your cleaning and impurity control protocols
  • Equip your team to respond confidently to audits and inspections


KEY AREAS COVERED
  • NDMA, NDEA, and NMBA: Structure, properties, and regulatory thresholds
  • Trace analysis techniques for detecting toxic impurities
  • Root causes of contamination in sartan recalls
  • Mechanisms of nitrosamine formation in APIs
  • EMA vs. FDA regulatory positions and compliance implications
  • Forward-looking risks and toxic impurity concerns in modern pharma

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

Dr. LOREN GELBER

Dr. Loren Gelber has spent over four decades immersed in pharmaceutical compliance, including nearly a decade inside the FDA as a generic drug reviewer. With deep experience across both regulatory and industry sides, she’s helped countless companies navigate impurity risks and regulatory inspections with clarity and precision. If you need smart, actionable guidance on toxic impurities, she’s the expert you want leading the way.

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