Documentation Management and Control

The Center for Professional Advancement
East Brunswick, New Jersey, United States

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

Course Description:

'' FDA regulations such as Good Manufacturing Practice (GMP) for drugs and medical devices, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), as well as quality system standards like ISO 9000, require that documentation, such as standard operating procedures, plans and various types of records, be in place. These regulations, however, do not provide any guidelines to the industry on how to set up and manage documentation systems. It is, therefore, left to companies to design and set up their own internal documentation systems.

This course provides hands-on methodology and techniques on how to identify what systems require documentary coverage; how to flowchart operations to identify what type of documentation is required; and how to set up, implement and manage the maintenance of such documentation systems to ensure continuous compliance. Types of documentation addressed include: quality manuals, policy manuals, standard operating procedures, work instructions, forms, records, logs, protocols, etc. The course also covers areas related to computer validation documentation, such as validation protocols and 21 CFR Part 11¡ªElectronic Records and Signatures. Emphasis is placed on controls that need to be in place to ensure proper manipulation of documentary systems.

The course consists of lectures, discussions and interactive workshops with classroom presentations.
...''

Phone:(732)238-1600

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: East Brunswick
Houses & Roommates: East Brunswick

Starch: Chemistry, Properties and Applications
Food Extrusion Technology
Complaint Procedures for Medical Devices
Microencapsulation and Particle Coating
Nanotechnology
ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies
Project Management
Risk Analysis & Human Factors Engineering
Gums and Hydrocolloids
Microencapsulation and Particle Coating
Analytical Methods Validation for FDA Compliance
Drug Product Stability and Shelf-Life
Microbiological Control and Validation
Process Validation for the Pharmaceutical and Medical Device Industry
Non-Clinical Drug Safety Evaluation and Drug Development
ADME: Absorption, Distribution, Metabolism and Elimination
Root Cause Investigation for CAPA
Complaint Procedures for Medical Devices
Early Stage Clinical Studies for Drugs and Devices

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