ARV

Pharmaceutical cGMP and the Approval Process - A Quality System Approach

With former US FDA director Dr. Kaiser Aziz 

December 9th-11th 2008, Murray-Edwards (New Hall) College, Cambridge, UK.

A must for anyone in pharmaceutical or combination product compliance, R&D, manufacturing or quality systems.

About Dr. Aziz

Dr. Aziz spent 29 years with the US Food and Drug Administration (FDA). His career included posts as chief clinical Chemistry, Haematology and Pathology and Director of Division of Mechanics and Materials Science at the FDA. He lectures Physicians at the United States National Institiute for Health graduate school and has written for and edited journals in the fields of Nano Medicine and Biomarkers. Dr. Aziz had a distinguished career as a regulatory scientist and manager of drug and device evaluations, approvals, standards, good manufacturing and quality system applications.

 

About the Programme 

 

Over 3 days at Murray Edwards College (New Hall), Cambridge Dr. Kaiser Aziz will provide training and share valuable insights into the US Food and Drug Administration's cGMPs for development and manufacturing.  This course covers key aspects of clinical trial design, new drug applications and the approval process. The course will include discussions on the use of biomarkers and Nano technology from a regulatory perspective. If you are involved in any aspect of pharmaceutical development or manufacture then this course is a must.  

Image of the Murray Edwards College



Click here for enquiry or call +44 (0)207 1834518
or use the fax back form on the attached brochure.

Day 1 Day 2Day 3
cGMP: Regulations, Compliance and InspectionQuality Systems, Drug Development, Regulatory Practice and ApproachClinical Research Development, New Drug Applications, Clinical Study Design
 09:00Registration
 10:00Module 1, FDA and the FD&C Act
 11:00Module 2, Regulatory Perspectives on CGMP
 13:00Module 3, 21 CFR Part 210 CGMP in Manufacturing, Processing, Packing, or Holding of Drugs (general)
 15:30Module 4, FDA Compliance and Inspectional Observations
 17:00 Close
 08:40Registration
 09:00Module 5: Quality Systems Approach
 13:00Module 6: Drug Development
 15:30Module 7: Regulatory Practices and Procedures of New Drug Development and Approvals
 17:00 Close
 08:40Registration
 09:00Module 8: Clinical Research Development
 13:00Module 9: Specific Aspects of New Drug Applications
 15:30Module 10: Good Clinical Practice and Management of the Clinical Study Design
 17:00 Close
Course
Title: Pharmaceutical cGMP and the Approval Process - A Quality System Approach
Venue: Cambridge
Start date: 09/12/08
or call
+353 (0)61 448508
info@arvexcellence.com
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