|
Seminer Sunumlarý Development
and Basic Concepts of GMP Requirements Dr.
Andreas Brutsche, Novartis Pharma Stein AG, Stein, Switzerland Regulatory
and Legal Basis for Good Manufacturing Practices Dr.
Jürgen Mählitz, Preparation and
Management of International Inspections (FDA, PIC, EMEA) Dr.
Andreas Brutsche, Novartis Pharma Stein AG, Stein, Switzerland Regulatory
Inspection for GMP Compliance, Major Inspection Findings Dr. Jürgen Mählitz, GMP Upgrade
Projects to Achieve FDA Approvalibility Dr. Andreas Brutsche, Novartis Pharma Stein AG,
Stein, Switzerland GMP Inspection
of Pharmaceutical Plants: Case Studies Dr.
Michael Pfeiffer, Boehringer Ingelheim Pharma GmbH & Co. KG, An Excellent Quality Assurance System is A
Key Dr.
Michael Pfeiffer, Boehringer Ingelheim Pharma GmbH & Co. KG, Deviation and Out of Specification Handling Dr. Jürgen Mählitz, GMPs for the 21st
Century - The Risk Based Approach: A New Initiative from the FDA Dr. Andreas Brutsche, Novartis Pharma
Stein AG, Stein, Switzerland Compliance
to Good Laboratory Practices Dr. Michael Pfeiffer, Boehringer
Ingelheim Pharma GmbH &
Co. KG, Qualification
/ Validation Requirements for Product Launch / Transfer Dr.
Andreas Brutsche, Novartis Pharma Stein AG, Stein, Switzerland |