Microbial Data Deviation Investigations, The Role of Deviations, Out of Specifications, CAPAs and Risk Management within Microbial Data Deviations and How the FDA and ICH Regulations and Guidances Impact Them

Live, Interactive Training Webinar

Date: Tuesday February 12, 2019
Time: 10:30am - 12:30pm ET (New York Time)
Instructor: Barry A. Friedma Ph.D. Biography>>>

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Microbial data deviation investigations come in a multiplicity of forms and may vary from the very simple to include the incubation of a plate at an incorrect temperature to attempting to determine the "root cause" of a sterility test failure. The resultant investigations and their data requirements may be very short in duration, e.g., a matter of only several to 40 – 50 hours. However, unlike chemical analytical deviations and their Out Of Specification (OOS) studies and Corrective/Preventive Action (CAPA) programs, the length of time to complete these microbiological investigation studies may extend to as many as six months based on the laboratory studies that may be required.

The objective of this live training webinar is to explore the more common microbiological aspects of data deviation investigations, and how FDA and ICH regulations and guidances impact them.

Learning Benefits:
-What are the more common microbiological data deviations.
-How do these deviations occur?
-What solutions exist for minimizing and eliminating these deviations.
-How a deviation becomes an OOS and when a CAPA may be required.
-How the process may be shortened.
-How the use of metrics may provide a “roadmap” for action.
-Why trending of deviations, OOS and CAPAs is important for both the site and during regulatory audits.
-The role of Risk Management and the relationship to microbial data deviation investigations

Webinar outline and time breakdown:

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
The Role of Deviations, Out of Specifications, CAPAs and Risk Management within the arena of Microbial Data Deviations,
FDA Considerations: -- When Deviations are required -- When Out of Specifications (OOS) are require -- When Corrective Actions/Preventive Actions (CAPAs) are required -- When Risk Management is required,
Elements of Deviations, OOS, CAPAs and Risk Management,
11:30 AM Break
11:40 AM Why trend these data,
A Review of the More Common Microbiological Deviations,
The impact of Risk Management and relationship to microbial data deviation investigations,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Auditing Professionals

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Course Number: 229

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland

Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>