Course Number: 211

Laboratory Quality Practices for Global Regulatory CMC Analytical Studies for Biotechnology/Biosimilar Products: R&D to GMP

Live, Interactive Training Webinar

Date: Wednesday January 16, 2019- Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Nadine M. Ritter Ph.D. Biography>>>

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During the course of product development, and in the support of commercialized products, there are numerous biotech CMC studies conducted in non-GLP/non-GMP analytical laboratories (“R&D” labs). While it is true that these R&D labs are not required to follow GxP regulatory compliance statutes, much of the data they generate are used to support critical decisions on the process and the product. With the advent of biosimilar products, the role of R&D labs in product development has expanded to include extensive analytical comparability assessment of originator vs biosimilar product candidate.

Many sections of product regulatory dossiers include analytical data obtained from R&D labs. In addition to product characterization and comparability studies, data to support QC test method selection, optimization, qualification and validation, and the establishment of product reference standards, may be generated in R&D analytical development groups. So to support the integrity, reproducibility and traceability of key CMC analytical data, some biotech R&D laboratories have adopted a ‘best-practices’ strategy for quality practices. These measures are appropriately geared to non-GxP labs to assure the reliability of their data without constraining the flexibility of the studies they must conduct.

The objectives of this live training webinar are to review the nature of R&D analytical CMC studies that are required to be reported to regulatory authorities as a part of the product dossier, illustrate the relationship among existing quality practice guides (such as ISO17025), and present elements of ‘best practices’ strategies that should be employed by R&D analytical groups who contribute data to product development or commercial product support. It will also highlight elements typically reviewed in due diligence audits of R&D labs for potential project partnering or selection of contract testing labs.

Learning Benefits:
-Provide a review of the types of analytical studies conducted in R&D labs.
-Explain the expectations for R&D data integrity and reproducibility.
-Show where the existing regulatory and industry guidances do, and do not, apply to R&D labs.
-Learn of common mistakes made in R&D laboratory operations.
- Illustrate the basic ‘best practice’ operational elements that should be employed in R&D labs .

Webinar outline and time breakdown:

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Examine the R&D analytical studies required in product dossiers,
Compare the current regulatory and industry guidances on lab quality practices,
Illustrate the regulatory risk and the business risk of R&D data integrity,
11:30 AM Break
11:40 AM Illustrate the basic Best Practice principles for R&D laboratories,
Present examples of common mistakes in R&D analytical data,
Discuss practical issues on how to implement R&D Lab Quality Practices,
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
  • Regulatory Affairs Scientists
  • Contract Laboratory Personnel
  • Project Managers (clinical and commercial products)

Registration Form ►


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>>>

 

 
The objectives of this live training webinar are to review the nature of R&D analytical CMC studies that are required to be reported to regulatory authorities as a part of the product dossier, illustrate the relationship among existing quality practice guides (such as ISO17025), and present elements of ‘best practices’ strategies that should be employed by R&D analytical groups who contribute data to product development or commercial product support. It will also highlight elements typically reviewed in due diligence audits of R&D labs for potential project partnering or selection of contract testing labs.

System Requirements:

All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.

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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