Course Number: 210

Current FDA and Global cGMP Compliance Requirements and Guidances for In-House and Contract Analytical QC Laboratories; Understanding the Unique Elements of cGMP Applicable to QC Analytical Testing Laboratories

Live, Interactive Training Webinar

Date: Wednesday January 29, 2020 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Nadine M. Ritter Ph.D. Biography>>>

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Good Manufacturing Practices (GMP) regulations are generally well recognized as applying to production processes and manufacturing facilities. Less obvious may be the unique elements of cGMP that are applicable to QC analytical testing laboratories, and how the ‘sliding scale’ of GMP changes for the testing laboratory during product development. In some cases, laboratories even misclassify their operations as GLP (Good Laboratory Practices) as a way to indicate early phase GMP operations.

Increasingly, FDA inspections have been finding instances of QC laboratory violations of cGMP for commercial products. Additionally, elements expected in complete validation packages for cGMP test methods have been addressed in the new draft FDA Guidance on Analytical Procedures and Methods Validation for Drugs and Biologics, which is designed to supplement ICHQ2R1 Test Method Validation. Finally, the cGMP compliance requirements for analytical testing laboratories is equally applicable to sponsor facilities as well as contract organizations, as outlined in the new draft FDA Guidance on Contract Manufacturing Arrangements for Drugs: Quality Agreements, which contains specific sections on contract testing laboratories. The objectives of this live training webinar are to review the operational compliance requirements for laboratory cGMP, and present examples of current ‘hot button’ lab audit issues. It will provide information specific to QC analytical laboratory quality practices as a component of annual training cGMP requirements, which is frequently overlooked in most cGMP training programs.

Learning Benefits:
-Provide a overview of ‘where it is written’ for laboratory cGMP requirements and lab inspections.
-Explain the practical elements of laboratory operations under cGMP practices.
-Learn the current expectations for validated methods to remain in a state of control.
- Show recent observations from warning letters of deficiencies in lab cGMPs (including contract labs).

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Present the global regulatory statutes and guidances for laboratory cGMPs,
Review the global regulatory statutes and guidances for laboratory inspections,
Show recent observations from warning letters on lab cGMP deficiencies,
11:30 AM Break
11:40 AM Explain the statutory elements of laboratory cGMPs,
Choosing the Appropriate Method, Training the Personnel,
Illustrate additional practical issues for laboratory cGMPs,
Discuss current expectations for tracking/trending of validated method performance,
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 participation for attendee training records

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

  • Quality Assurance Personnel
  • Quality Control Analysts
  • Research & Development Scientists
  • Regulatory Affairs Professionals
  • Contract Laboratory Personnel
  • Project Managers (clinical and commercial products)

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Instructor: Nadine M. Ritter Ph.D.

Dr. Ritter's professional efforts have significantly contributed to the success of over 70 national and international biotechnology and biosimilar product IND/IMP filings and BLA/MAAs for drug substance and drug products, including two break-through therapeutic products, several biosimilar products in the EU and Canada. In addition, her work has been instrumental in remediating gaps and obtaining successful resolution to BLA CRL and RTF actions, and in resolving laboratory quality problems in firms under cGMP consent decrees... Full Bio>>>



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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