Avoiding Problems with FDA in Manufacturing Parenteral Products

Avoiding Problems with FDA in Manufacturing Parenteral Products - Webinar CD/Transcript

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Avoiding Problems with FDA in Manufacturing Parenteral Products: Recent FDA Enforcement and Recommended Improvements

Parenteral drug products have been under a barrage of GMP-related problems of late. From cloudy vials to glass shards in syringes to microbial contamination, parenteral manufacturing has taken a hit.

Avoiding these problems lies in understanding what the FDA expects of your manufacturing procedures and looks for during an inspection. Plus, the FDA is keen on understanding the safeguards and SOPs you have in place to assure compliance.

Ben Franklin said "an ounce of prevention is worth a pound of cure." Commissioner Hamburg might say, “an extra ounce of Parenteral GMP oversight can save lives.”

FDA says in its cGMP guidance on aseptic processing of sterile drug products that "...Manufacturers [must] have a keen awareness of the public health implications of distributing a non-sterile drug product. Poor CGMP conditions at a manufacturing facility can ultimately pose a life-threatening health risk to a patient."

Based on recent patient deaths and Class I recalls of some products made by compounding pharmacies, sterile and aseptic drug and biologic manufacturing is once again an area of public concern.

In this webinar CD and transcript, listeners will learn how to:

  • Dissect recent FDA warning letter citations to understand what the FDA’s investigators are focusing on
  • Review and analyze specific FDA 483 observations and tips and suggestions that could have avoided the violations
  • Highlight serious compliance cases and how to build a compliant culture
  • View from the trenches — how FDA inspects parenteral facilities
  • Use resources to assess cGMP systems for patient safety and FDA compliance
  • Rank the factors that might lead to an FDA warning letter
  • More suggestions for improvement — best practices that every firm should have in place
  • Pharmaceutical Companies
  • Biotech Companies
  • Contract Manufacturers
  • Combination Products Companies

Barbara Immel is one of the most listened to FDA enforcement and compliance speakers in the pharmaceutical, biologic, and medical device industry. She has 31 years of industry experience in quality assurance, regulatory compliance, and training. She serves as chairperson of the Annual FDA Inspections Summit hosted by FDAnews.  A CGMP columnist for BioPharm Magazine for more than a decade, she has published more than 50 articles in industry trade journals and is the author of the quality assurance chapter in Dekker's Encyclopedia of Pharmaceutical Technology. She has created and taught industry classes at the University of California, Berkeley; Stanford University, the University of Wisconsin at Madison, the University of Georgia, and Rochester Institute of Technology. As President and Founder of Immel Resources LLC, she provides auditing, training, corrective and preventive action, investigations, and compliance consulting for industry clients worldwide (Immel Resources celebrates its 17th anniversary this year.) Before starting Immel Resources, she worked for Syva Company, Chiron Corporation, and Syntex Corporation (now Roche). Barb is a graduate of the University of California, Santa Barbara, the Buckley School of Public Speaking, and Stanford Professional Publishing Course.