Uncertainty in Laboratory Measurements within the Microbiological & Chemistry Areas Related to FDA Compliance and Review of Recent Warning Letters

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

Measurements within the R&D and Quality Control Laboratories often create issues with those involved -- whether it be the technician, supervisor or laboratory manager. These measurement issues may be extremely simple or very difficult to discern based on the newness of the assay, its complexity, the training of the personnel, etc. The FDA will often comment on a Client's difficulty to follow/ interpret an assay -- whether it be a USP/EP/JP assay or one developed by the Client.

The assays may vary based on the compendial method being followed, e.g., USP, EP, or JP or, because no method exists. Often the development of new technologies also require the development of new assays or comparable assays that achieve levels of precision, accuracy and quantitation that have not been previously achieved.

Warning Letters will be presented to document some of the various testing issues that the FDA has discovered during recent audits and include recommendations where possible.

The objective of this live training webinar will be to explore selected "Uncertainties" within the microbiological and chemistry areas related to FDA compliance, to offer various solutions to assist your organization with FDA compliance initiatives and to provide your organization guidance to maintain itself within a cGMP compliance framework.

Learning Benefits:
-Examination of Selected Chemistry and Microbiological Inconsistencies Observed within the R&D and Quality Control Laboratories.
-Issues Associated with using Compendial Methods to obtain consistency within Assays.
-Dealing with Uncertainty within Non-Compendial Assays.
-Management of Non-Compendial Assays.
-How your Incoming Raw Material Vendors may create additional Uncertainty in your Assay Testing.
-Product Acceptance Criteria and its Impact Upon Uncertainty.
-How Validation Criteria impact Accuracy, Precision, Linearity and Range.
-How to become aware of Uncertainty in an assay.
-What can be done to eliminate Uncertainty.
-How to work with your vendors to eliminate Uncertainty.
-How to explain "built-in" Uncertainty to your co-workers.
-How significant figures can be used to pass or fail an assay.
-Why chemists have such difficulty understanding microbiological quantitation.
-Review of FDA Warning Letters that incorporate Uncertainty.

Webinar outline and time breakdown:

9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Definitions,
Uncertainty in Microbiology -- General Issues Causing Uncertainty,
Uncertainty in Microbiology -- Specific Issues Causing Uncertainty Testing as a Strategy
FDA Issues with Microbial Dilutions,
10:30 AM Break
10:40 AM The Meaning of "Nil" Microorganisms,
Objectionable/Specified Microorganisms,
FDA 483s and Warning Letters,
11:30 AM 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 participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
The following individuals or disciplines will benefit from attending this Webinar:
Those who will benefit from this seminar include R&D, Validation, Regulatory Compliance, Quality Assurance, Quality Control, and Manufacturing professionals who are required to maintain standards of compliance consistent with the latest revisions of the cGMP as well as those that use contract manufacturing and contract testing facilities for their testing applications.

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>>>



Course Number: 235

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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