Quality Audits

The Center for Professional Advancement
Amsterdam, Netherlands

Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced

Course Description:

'' Government regulations have both explicit and implicit requirements for an internal audit function in the pharmaceutical and related industries. Auditing is a powerful management tool in establishing how effectively a company controls the quality of its products and ensures compliance. The first four days of the course will deal primarily with auditing techniques which are applicable to any industry or function. Specific examples will cover auditing of certain aspects of operations for compliance with GMP, GCP and GLP. An FDA viewpoint on auditing/inspecting will be presented. The optional fifth day will deal with flowcharting techniques and methodology for writing standard operating procedures using the playscript style. The course will consist of lectures, discussions, exercises, workshops and a roleplaying session involving a simulated compliance audit. The course is not designed for in-depth presentation of regulatory issues, which are covered by other courses offered by CfPA.

This overview course is for those who have recently been involved or expect to be involved in external or internal audits. The program will benefit individuals in the pharmaceutical and related industries such as cosmetics, food, medical devices, diagnostics, biotechnology as well as vendors, suppliers and contract organizations. The course can be of interest to professionals in a variety of functions such as:

QA/QC
R&D
Regulatory
Materials Management
Packaging
Laboratory
Production
Toxicology
Clinical Research
Purchasing
...''

Phone:+31/20/638.28.06

School Address:

Corporate Office
Box 7077, 44 West Ferris Street
East Brunswick, NJ USA 08816-7077
Phone: (732)238-1600
Fax: (732)238-9113
Email info@cfpa.com

Europe Office
Oudezijds Voorburgwal 316A, 1012 GM
Amsterdam, The Netherlands
Phone +31/20/638.28.06
Fax +31/20/620.21.36
Email amsterdam@cfpa.com



Jobs & Resumes: Amsterdam
Houses & Roommates: Amsterdam

Process Plant Start-Up
Preparation, Packaging and Labeling of Clinical Trial Materials
Cost Effective Quality-by-Design and Critical-to-Quality Tools for PAT
Conception, Design and Implementation of Plant Safety Systems
Pilot Plant and Scale-up Studies
Atomization, Sprays and Atomizers
Introduction to Skin Aging
LAL Testing: Drugs, Medical Devices and Biopharmaceuticals
Root Cause Investigation for CAPA
cGMP for Pharmaceutical Production Supervisors
Applied Process Engineering
Documentation Management and Control
Equipment Qualification in a Nutshell
Skin Product Development
International Patent Law
Near Infra-Red Spectroscopy
Analytical Methods Validation for FDA Compliance

Notice: The course description on this page was captured from the Internet as historical reference or submitted by visitors. It was archived statically and not updated from day to day.
 

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