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Does your pharmaceutical lab have GMP and non-GMP functions?

 
  January 03, 2011  
     
 


ComplianceOnline, Online Event
2011-01-19


NOTE: Use This Promocode ( 117660 ) To Get 10% Discount. 

Why Should You Attend:

If a laboratory is dedicated either to GMP testing and validation activities or to method and procedure development and validation, then the laboratory is responsible for following the appropriate CFRs. GMP guidance’s for the pharmaceutical industry are included in 21 CFR, and for GLP guidance’s can be found in 58 CFR. However, if both types of work are being done in the same laboratory and even by the same analysts, it is critical to define boundaries. This involves not only the analysts and the laboratory management but extends to reviewers of critical documents and client education regarding the practices and policies.

Attend this webinar with your team to understand the pitfalls and risks of having GMP and GLP practices occurring in one location and strengthen the understanding of the lifecycle of a method or procedure.

Areas Covered in the Seminar:

  • CFR guidance for GMP testing of pharmaceutical products.
  • CFR guidance for GLP practices and method and procedure development.
  • The transition from a procedure in development to one used routinely.
  • Establishing boundaries.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:
  • QC functions in general
  • QC technical transfer groups
  • QC validation groups
  • Commercial testing facilities
  • Product development
  • QA reviewers who are responsible for both GMP and GLP documentation practices
 
 
Organized by: ComplianceOnline
Invited Speakers: Barbara Berglund, has been working in the pharmaceutical industry, specifically with sterile parenteral dugs, for over 10 years. Her experience includes her current role as a QC Manager as well as roles in the laboratory, project management, and clinical trial manufacturing. The QC group she manages is directly responsible for method transfer and validation activities in support of contract manufacturing clients. She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and Pharmacological and Physiological Science. She received her PMP certification in 2007 and her Green Belt certification in 2008.
 
Deadline for Abstracts: 2011-01-19
 
Registration:

Attend Live Online Training

$199.00 One Dial-in One Attendee

$899.00 Group–Max. 10 Attendees

 

 

E-mail: admin@complianceonline.com
 
   
 
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