2014 - Webinar on GCP/GLP/GMP : Comparison of FDA’s 3 Major Regulations

These are the 3 major regulations FDA uses to regulate the Pharmaceutical/Medical Device industries in the USA. This web presentation presents an overview of FDA’s 3 major regulations ? Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Although varying slightly in different regions of the world these 3 regulations have the same basic elements and interpretations globally. Learn the requirements for each regulation, how they fit into the development process and how they are same and how they differ. Learn when to use each regulation and how FDA interprets the regulation.
Areas Covered in the Session :
? Overview of each regulation ? GCP, GLP, GMP
? How each regulation is the same
? How each regulation differs
? FDA’s interpretation of each regulation
Who Will Benefit:
? Regulatory Affairs Personnel
? Research Personnel
? Manufacturing Personnel
? Clinical Personnel
? Nonclinical Personnel
? Lab Personnel
? Quality Personnel
? Auditors
? Personnel who require a general understanding of the FDA’s 3 major regulations
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
Speaker Profile:
Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements
For more information Contact:
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