Webinar on GCP/GLP/GMP : Comparison and Understanding of FDA's 3 Major Regulations
- Start Date:
- Tuesday, 10 May, 2016
- End Date:
- Tuesday, 10 May, 2016 2:00pm
- Internal Medicine, Physical Medicine, Business Practice, Health & Nutrition
Description :Various firms are subject to various relevant and applicable federal regulations including, but not limited to, Good Laboratory Practice (GLP), Current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP).It is important for the industry to accurately understand the requirements under Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP).This seminar is intended to help industry get better familiar with the GLP, GCP and cGMP requirements from regulatory, practical and compliance perspectives.
The speaker will walk you through regulatory and compliance requirements governing GLP, cGMP and GCP.Areas Covered in the Session :Applicable Laws and RegulationsFDA Guidance and StandardsMajor MisconceptionOverview of each regulation - GCP, GLP, GMPHow each regulation is the sameHow each regulation differsRegulations and Requirements for Good Laboratory PracticeRegulations and Requirements for Good Clinical PracticeRegulations for Current Good Manufacturing PracticeSpeaker's PASS-IT Recommendations: Best PracticesWho Will Benefit:CEOsVPsCompliance OfficersAttorneysRegulatory AffairsClinical AffairsQuality AssuranceResearch & DevelopmentLab PersonnelConsultantsContractors/Subcontractors Anyone who require a general understanding of the FDA's 3 major regulations
5939 Candlebrook Ct,
ON L5V 2V5,
Conference organized by Compliance Trainings
This new 2-day Seminar on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance.
- 861, Peripheral Road, Koramangala, Bangalore