GLP (FDA-FIFRA) Regulations – Roles and Responsibilities in a GLP Facility

This 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: Quality, Quality Systems
  • Global Scenario, Harmonization, ICH
  • Requirements of Quality Systems
  • Genesis of FDA GLP
  • Basic Definitions and Tenets of the GLP’s
  • Management
  • Study Director
  • QAU Roles & Responsibilities
  • Testing Facility: Definition and Requirement
  • Equipment: Various Equipment, Devices and Instruments
  • Protocol and Study Conduct
  • Study Conduct: Test Systems, Test in Control Articles
  • Systems and Procedures: Qualification and Validation
  • Computer Systems: Risk Assessment, ERES, Validation
  • Records: Storage and Retrieval: Archiving
  • Retention, Requirements
  • Implementation of GLP in a Testing Facility: Documentation, SOPs Case Studies and Group Exercise
  • References, Web Addresses, Sources
  • Comparisons: FDA/FIFRA GLP’s
  • Enforcement Actions: Disqualification and Suspension
  • From Abstract doc.
  • Conclusion

Who Should Attend:

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

FDB2192

Dr. Shib Mookherjea

Dr. Shib Mookherjea, is the Principal of ValQual International, Inc. (www.valqlaintl.com) and is a globally acclaimed Speaker and Consultant. He has extensive experience in R&D, Validation and Compliance Issues for Pharma, Biotech and Medical Device Industries; Quality Assurance, Quality Management and Quality Control in Pharma and Medical Device.

He is an SME in the areas of Methods Development and Validation of Analytical Methods, QA / Conformity Assessment in the Analytical Laboratory, as well as Analytical Development; Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ); Laboratory (Methods, Systems, Equipment Qualification), and Drug / Devices Development. He offers Consulting / Advisory on various aspects of cGMP /GLP/ISO 13485, ISO 9001, CAPA. He also conducts various audits for GMP & GLP (FDA/OECD); ISO 17025; Pharmaceutical Development (ICH Q6, Q7A, Q8). He has conducted GLP Studies (FDA/FIFRA) and has conducted hundreds of training sessions, workshops and short courses in diversified forums (for both public and in-house companies) covering various aspects of Quality / QA / Validation for Compliance to cGMP/GLP/WHO/EMEA/ICH etc. over the last 30 plus years, both in the continental U.S. and abroad.

He is an SME in the areas of Methods Development and Validation of Analytical Methods, QA / Conformity Assessment in the Analytical Laboratory, as well as Analytical Development; Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ); Laboratory (Methods, Systems, Equipment Qualification), and Drug / Devices Development. He offers Consulting / Advisory on various aspects of cGMP /GLP/ISO 13485, ISO 9001, CAPA. He also conducts various audits for GMP & GLP (FDA/OECD); ISO 17025; Pharmaceutical Development (ICH Q6, Q7A, Q8). He has conducted GLP Studies (FDA/FIFRA) and has conducted hundreds of training sessions, workshops and short courses in diversified forums (for both public and in-house companies) covering various aspects of Quality / QA / Validation for Compliance to cGMP/GLP/WHO/EMEA/ICH etc. over the last 30 plus years, both in the continental U.S. and abroad.

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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