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Webinar on The FDA Good Manufacturing Practices (GMP) for Drugs and Biologics

 
  July 18, 2014  
     
 


Compliance Trainings, Canada
2014-07-24


This webinar is a must for those personnel that require an understanding of the regulation governing manufacturing operations. FDA’s regulates the manufacture of Drugs and Biologics under the Good Manufacturing Practices (GMP) regulation 21 CFR Parts 210-211.

FDA regulates the manufacture of Drugs, Biologics and Veterinary products in the USA under a regulation called the Good Manufacturing Practices (GMP) Regulation. This webinar will address the reasoning for and requirements of the GMP. Every section of the GMP (Subparts A – Subpart K) plus the Introduction in 21CFR Part 210 will be reviewed and discussed. FDA’s “umbrella” approach to the GMP will be discussed and FDA interpretations of the GMP reviewed. This webinar will provide an understanding of the intent and expectations of FDA relative to the GMP.

Areas Covered in the Session :

FDA’s GMP regulation

Understanding Parts 210-211

Understanding Subparts A-K

Understanding of the GMP regulation

FDA’s "umbrella" approach

Interatcive Q&A session

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Laboratory Personnel

Manufacturing Personnel

Legal Personnel

Auditors

Clinical Research Associates

Personnel who require a general understanding of the FDA’s GMP regulation – 21CFR Parts 210-211

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

 
 
Organized by: Compliance Trainings
Invited Speakers:

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.

 
Deadline for Abstracts: July 23, 2014
 
Registration:

For more enquiries

Compliance Trainings

5939 Candlebrook Ct, 
Mississauga, ON L5V 2V5, 
Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

To register this webinar visit

https://compliancetrainings.com/siteengine/Login.aspx 

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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