Web seminar - How to Investigate Deviations and Failures Effectively

04/04/2012 - 12:01pm
Etc/GMT-8

 

Cost Effective and Convenient - in your office or conference room

How to Investigate Deviations and Failures Effectively

Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.

April 4, 2012
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Investigation of failures and deviations in the pharmaceutical industry is a regulatory requirement. Recording the deviations and investigating their cause is but one step to meet the regulatory requirements. Correcting the issue based on risk assessment and understanding of the science as well as ensuring that the corrective actions are implemented within the appropriate time frame is another step.

 
Follow-up of the actions to ensure they are completed effectively and the fact that no new issues have been introduced is what completes the activities. A summary report must be developed, reviewed, and approved by the quality unit. Process monitoring, Quarterly Review of all deviation reports as well as Annual Product Reviews (APR) are the tools necessary to ensure that negative trends do not develop and that the manufacturing process remains under control.
 
By participating in this seminar you will learn:

  • What the applicable regulatory requirements are
  • What constitutes a deviation/discrepancy/failure
  • What are the various types of deviation you may encounter
  • How to conduct an investigation
  • How to use risk assessment as a tool to define the appropriate corrective and preventive actions
  • How to prepare a deviation summary report
  • Why product reviews are critical

This seminar will be conducted on the telephone and is presented by Gamal Amer, Ph.D., an industry expert on this and other compliance related topics.

In this unique web seminar format, lasting just one hour, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Dr. Amer. Dr. Amer's qualifications can be found below.

The handout presentation file will be sent to you via email the day before the seminar.

 
How to Investigate Deviations and Failures Effectively

 

Part I - Risk as it Applies to Compliance

  • What is risk?
  • How to define the levels of risk
  • What events may cause, or increase the potential of risk?
  • How risk manifests itself

Part II - CAPA as a Method to Mitigate Risk

  • Learn how to identify non-conformances and deviations
  • Learn how to document a non-conformance and deviation
  • Evaluation and risk assessment of non-conformances and deviations
  • Learn what information is needed to evaluate non-conformances and deviations
  • Learn how to address non-conformances and deviations within a CAPA program
  • Learn how to investigate and determine the severity of non-conformance and deviations
  • Learn how to track and dispose of non-conformances and deviations

Part III - Questions and Answers

  • Dr. Amer will field your questions live on the phone. You will hear all questions and answers from all participants of this seminar.

 Register now!

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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the presentation handout materials the day before the seminar.

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Get the MP3 file and handout
GMP120404E - MP3 audio file and Handout materials
How to Investigate Deviations & Failures Effectively		 $397.00 Add to Cart

Instructor

Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations.

Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.

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