3-Hr Virtual Seminar: GLP (FDA-FIFRA) Regulations: Roles and Responsibilities in a GLP Facility

Why Should You Attend:

This 3 hr 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 Webinar:

• 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
• From Abstract doc.

Highlights of Topics:

• 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: Definition, Scope, Role, Responsibilities
• Study Director: Definition, Scope, Role, Responsibilities
• QAU: Definition, Scope, Role, 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
• Conclusiion

Who Will Benefit:

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

Shib Mookherjea
Principal, Validation Quality International Inc

Dr. Shib Mookherjea is the Principal of Validation Quality 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.

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