3-Hours Virtual Seminar on Highlights of FDA GLP Regulations and the Roles and Responsibilities in a GLP Facility - Webinar

  • ID: 4600432
  • Webinar
  • 180 Minutes
  • NetZealous
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This 3 hour GLP virtual seminar will discuss various GLP regulations (FDA/OECD GLP's) along with highlighting roles and responsibilities of management and key personnel involved in drug development, safety & toxicity evaluation and QAU function in GLP testing facilities.

Why should you Attend: This 3 hour GLP Webinar will cover some of the major requirements, definitions and elements of the various GLP regulations, and the FDA/OECD GLP's. it will discuss the strategies to apply in effective implementation of a compliant GLP program with involvement and interactions and Case Studies and group exercise included in this highly interactive course presentation.

It also aims at scoping out the Roles and Responsibilities of the Study Director, Management ,supervisors, scientists, investigators ,Regulatory , QAU and other personnel in GLP facilities, Contract Laboratories, Research Institutes or other organizations engaged in the conduct of GLP (FDA, FIFRA, OECD, JAPAN) studies and other non-clinical studies related to Drug Development, Safety & Toxicity evaluations and QAU function in GLP testing facilities.

Comparison and differences between the FDA and OECD GLP's will also be included. Real life examples and case studies will be included in this highly interactive presentation.

Areas Covered in the Session:

Introduction: Background of GLP's
Quality System Perspectives
Organization and Personnel
QAU: Audits and Responsibilities
Facilities
Study Conduct
Protocols
Equipment and Systems
Reagents and Solutions
Test and Control Articles
QAU: Audits and Responsibilities
Final Reports
Comparisons: FDA/FIFRA GLP's
Enforcement Actions: Disqualification and Suspension
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  • Shib Mookherjea Shib Mookherjea,


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  • Study Directors
  • Managers
  • Supervisors
  • Validation Managers
  • GLP Coordinators
  • QAU Personnel
  • Lab Personnel
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