This web seminar presents an overview of FDA’s GLP regulation – 21 CFR Part 58. The FDA GLP regulation complies with all GLP requirements globally. This web seminar covers every section of the FDA GLP regulation, offers FDA interpretation and provides an understanding of nonclinical safety research on a global basis. The web attendee with obtain a foundation of knowledge about FDA, the GLP regulation and nonclinical studies.

This webinar is a must for those personnel that require an understanding of the regulations governing laboratory activities relative to nonclinical testing that support or are intended to support applications for products regulated by FDA.

Areas Covered in the Session :

FDA's GLP regulations: 21 CFR Part 58

Objectives and concepts of GLP

Required GLP Studies

Responsibilities of different personnel

Data generation and evaluation

How to implement GLP’s

FDA interpretation of 21CFR Part 58

Who Will Benefit:

A must attend webinar for:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Laboratory Personnel

GLP auditors

GLP study directors

Manufacturing Personnel

Legal Personnel

Auditors

Training Departments

Clinical Research Associates

Consultants

Personnel who require a general understanding of the FDA’s GLP regulation – 21 CFR Part 58

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.

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