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Monoclonal Antibodies and Therapeutic Proteins: Designing GLP Compliant Nonclinical Programs to Meet FDA Expectations

Instructor: Steven S Kuwahara
Product ID: 700871
  • Duration: 60 Min

recorded version

$249.00
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2008

Training CD

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Read Frequently Asked Questions

This presentation will cover the GLP requirements for animal studies, and the methods that laboratories employ to comply with the regulations.

Description

This webinar will be directed at personnel who must conduct or review the performance of non-clinical laboratory studies related to safety. GLP studies apply to animal studies that are required in all regulated areas.

During the development of monoclonal antibodies and therapeutic proteins, it is important to establish the safety of the products by animal testing before proceeding with clinical trials that involve humans. Animals will also be employed to determine early estimates of pharmacokinetic parameters and the effective dose. These studies must be conducted using the Good Laboratory Practice (GLP) standards and regulations that are described in 21 CFR 58. This presentation will cover the GLP requirements for animal studies, and the methods that laboratories employ to comply with the regulations.

Areas Covered in the seminar:

  • Discussion of the regulations that apply to laboratory studies using animals to demonstrate safety.
  • Laboratory organization requirements based on 21 CFR 58.
  • Preparing the study protocol.
  • Physical organization of the laboratory and requirements for animal handling.
  • Activities of the study director.
  • Activities of the quality assurance unit.
  • Preparing the final study report.
  • Institutional Animal Care and Use Committee.

Who will benefit:

This webinar will be directed at personnel who must conduct or review the performance of non-clinical laboratory studies related to safety. GLP studies apply to animal studies that are required in all regulated areas. The employees who will benefit include:

  • Test facility employees who must conduct non-clinical studies
  • Supervisors and auditors who must review non-clinical laboratory studies
  • Regulatory personnel who must prepare submissions based on non-clinical laboratory studies
  • QA and QC personnel who must deal with contract testing laboratories that perform non-clinical studies
  • Regulatory affairs personnel dealing with early stage products
  • Consultants

Instructor Profile:

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. He has performed audits of contract testing laboratories and performed evaluations of R & D laboratories and GLP testing laboratories.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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