Webinar On Good Laboratory Practice Regulations

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Good Laboratory Practice Regulations
Product Id
FDB1225
Food, Drugs Biologics
Category
Scheduled On
Wednesday, July 9, 2014 at 1300 Hrs
Duration
120 Minutes
Speaker
Albert A. Ghignone
To register for this webinar please visit
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• Webinar Description

This web seminar presents an overview of FDAs
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.

Area Covered in 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 GLPs

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• Data generation and evaluation
• How to implement GLPs
• 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 FDAs GLP regulation 21 CFR Part 58

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.
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