Course offering number:0903-402
Course ID:
610
Applied cGMPs for Pharmaceutical and Allied Industries
March 23-25, 2009
Burlingame, CA
Who Should Attend
This is an ideal course to acquire current applications of
cGMPs. It offers latitude for discussion of fundamental as
well as evolving regulatory initiatives and other complex
issues. The course is distinguished for benefit to domestic as
well as non-US enterprises, including the following:
Positions
Analysts, Directors, Engineers, Executives, Investigators,
Internal Auditors, Managers, Operators, QA/QC, Research,
Supervisors, and Trainers
Industries
Academia, Biogeneric, Biological, Biopharmaceutical,
Combination Product Manufacturers, Consultants, Contract
Manufacturing, Dietary Supplements, Health Care, Legal,
All Pharmaceutical Aspects, Regulatory and Many Others…
Description
This course takes you through Current Good Manufacturing
Practice (cGMP) in the pharmaceutical and allied industries.
Topics covered include legal requirement for cGMP in the
Federal Food, Drug and Cosmetic Act and related
regulations. It addresses practical aspects of personnel,
facilities, equipment, components, manufacturing, laboratory,
packaging, labeling and QA/QC and provides an excellent
forum for training personnel in cGMPs. The faculty consists
of individuals with long and distinguished experience in the
field. Throughout this course, the relevance of FDA
inspections commonly surfaces. There is special emphasis on
discussing procedures and practices of the regulatory agency
to help firms comprehend management of FDA relationships.
Other Courses of Interest
Auditing for cGMP Compliance
Jun 18 2009, Amsterdam, The Netherlands
Conducting Effective Quality Audits
Mar 24 2009, Amsterdam, The Netherlands
cGMP for Pharmaceutical Production Supervisors
May 05 2009, New Brunswick, NJ
Documentation Management and Control
Feb 23 2009, New Brunswick, NJ
Documentation Management and Control
Mar 30 2009, Amsterdam, The Netherlands
Documentation Management and Control
Jul 13 2009, Burlingame, CA
Preparing for and Surviving an FDA Inspection
Aug 10 2009, New Brunswick, NJ
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
Jun 16 2009, Amsterdam, The Netherlands
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