Good Laboratory Practice Regulations

$299.00

Description:

This web seminar presents an overview of FDA’s GLP regulation – 21 CFR Part 58. The FDA GLP regulation complies with all GLP requirements globally. This web seminar covers every section of the FDA GLP regulation, offers FDA interpretation and provides an understanding of nonclinical safety research on a global basis. The web attendee with obtain a foundation of knowledge about FDA, the GLP regulation and nonclinical studies.

This webinar is a must for those personnel that require an understanding of the regulations governing laboratory activities relative to nonclinical testing that support or are intended to support applications for products regulated by FDA.

Areas to be Covered:

FDA’s GLP regulations: 21 CFR Part 58
Objectives and concepts of GLP
Required GLP Studies
Responsibilities of different personnel
Data generation and evaluation
How to implement GLP’s
FDA interpretation of 21CFR Part 58

Who will Benefit:

Regulatory Affairs Personnel
Quality Personnel
Clinical Personnel
Research Personnel
Laboratory Personnel
GLP auditors
GLP study directors
Manufacturing Personnel
Legal Personnel
Auditors
Training Departments
Clinical Research Associates
Consultants
Personnel who require a general understanding of the FDA’s GLP regulation – 21 CFR Pa

Albert A. Ghignone

Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements.

He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP). In addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical Research Group and the Naval Medical Research Group. He is a member of the Regulatory Affairs Professionals Society which elected him the 1984 Professional of the Year. He has served the society as Vice President, President and Chairman of the Board of Directors.

In recent years he has filed numerous FDA drug, biologic and medical device submissions for product approval. In addition he has been involved in two of the largest clinical trials conducted, the 8,000 patient clinical trial in Africa and the 16,000 patient clinical trial in Thailand.

$299.00

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance