Description:

It is important for the FDA-regulated industry to better understand applicable FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP) for drugs, biologics and medical devices including in vitro diagnostics (IVDs).
This webinar is intended to help the FDA-regulated industry get better familiar with the GLP, GCP and cGMP requirements from regulatory and compliance perspectives.
Good understanding and adequate implementation of the regulatory requirements under GLP, GCP and cGMP regulations are critical to make better, informed business and regulatory decision.  Adequate awareness can greatly help firms save a significant amount of various business resources.
In this presentation, the speaker will discuss FDA regulations including key provisions and requirements governing GCP, GLP and GMP applicable to drugs, biologics and medical devices including IVDs. 

Areas To Be Covered in this Webinar:

•    Laws and Regulations
•    Definitions
•    Good Laboratory Practice (GLP): Regulation and Important Requirements
•    Good Clinical Practice (GCP): Regulation and Important Requirements
•    Regulations for Current Good Manufacturing Practice (CGMP) for Food, Drugs, Biologics and Medical Devices
•    FDA Guidance(s) and Standard(s)
•    Best Practices When Implementing GLP, GCP and GMP: Dos and Don’ts
•    Speaker’s PASS-IT Recommendations

Who will benefit:

•    Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
•    Compliance Officers
•    Regulatory Affairs
•    Clinical Affairs
•    Quality Assurance
•    Laboratory Personnel
•    IT Professionals
•    R&D
•    Consultants
•    Contractors/Subcontractors
•    Other professionals interested in this topic