Pharmaceutical Manufacturing Troubleshooting

Instructor: Barrett Rabinow
Product ID: 704954
  • Duration: 90 Min
In this webinar you will learn how to recognize and analyze manufacturing issues related to different dosage forms, consider general approaches for their solution, understand when to call in the cavalry, and execute rapid decision making.
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Why Should You Attend:

In this session, the presenter will review classic pharmaceutical manufacturing problems for their lessons about trouble shooting in general. Specific manufacturing issues will be analyzed to see how decisions were made and how they affected the outcomes. Different dosage forms will be covered, solid oral dosage forms as well as parenteral. Different types of problems will be considered including investigation of unwanted color, particulate matter, impurities, and reduced potency. The interactions of multiple causes resulting in several different problems will also be illustrated.

Interpersonal considerations will be addressed as well. Your role and relationship to the problem owner can determine how deeply to develop a working relationship with him/her. This can become essential to identify all aspects of a problem initially, rather than to continually encounter new, previously undivulged information as the program evolves.

If the problem becomes sufficiently strategically important, it may pay to do much more to become a recognized thought leader in the area, thus fostering closer relationships with regulatory authorities. This can mean the difference between the regulators perceiving you as part of the problem vs. part of the solution. This could affect imposed timeframes, imposition of penalties, etc.

And finally, the ostrich-like, head in the sand approach to quality will be considered: do you test a problematic process with the possibility of a new problem falling into your lap, vs. letting sleeping dogs lie? This depends upon a complex assessment of the potential safety, hence ethical, aspects of the problem as well as the corporate culture, and your expected duration in that position.

Areas Covered in the Webinar:

If you have responsibility for maintaining levels of production and quality, you need to understand how to diagnose problems that arise as well as to:

  • Determine how to strategically approach the solution to a problem: fix it in the plant or build a model?
  • Decide when to call for reinforcements; Stay in your own world or reach out?
  • Understand how to select corrective actions and test them for efficacy
  • Gain confidence by seeing how related problems were solved
  • Acquire broad perspective to understand how immediate problems can have remote causes: Expand your horizons
  • Understand the interpersonal or political aspects of problem resolution

Who Will Benefit:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production managers
  • Manufacturing engineers
  • Production engineers
  • Design engineers and managers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
Instructor Profile:
Barrett Rabinow

Barrett Rabinow
Baxter Distinguished Scientist, Baxter Healthcare

Barrett Rabinow was previously a Baxter Distinguished Scientist at Baxter Healthcare Corporation where he worked for over 39 years. He received his A.B. from Cornell University in 1968 and a Ph.D. in Chemistry in 1974 from the University of Chicago. From 1975-1976, he completed postdoctoral fellowships in electrochemistry, and in clinical chemistry at Michael Reese Hospital, Chicago. From 1976-1977, he served as Director, Clinical Chemistry Laboratory, Norwegian-American Hospital in Chicago. He then joined Baxter Healthcare Corporation in 1977. His positions of increasing responsibility led to the position of Director, Chemistry, where he oversaw chemistry, particle science, material science, polymer technology, and manufacturing troubleshooting for the parenterals solutions business. Dr. Rabinow has been active in industry task forces, organized by the Parenteral Drug Association, AdvaMed, Association for the Advancement of Medical Instrumentation, and the International Standards Organization as well as collaborative studies with USP, FDA, and NIH. For six years, he identified and evaluated new business opportunities, leading to Baxter acquisitions. He has developed lifecycle reformulations of drugs with new pharmacological characteristics in the area of nanosuspensions and stereoisomers. He led a team developing innovative lean stability testing protocols for parenteral solutions. Dr. Rabinow has numerous patents to his credit in the area of pharmaceutical formulations, nanoformulations, and biomaterials. He has authored four book chapters and over 40 articles, in the areas of physical-organic chemistry, clinical and analytical chemistry, trace metals, biomaterials, packaging, pharmaceutical science, drug delivery, pharmacokinetics, pharmacology and drug targeting.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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