This online course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except for the requirement that systems be validated. Even though it draws upon medical device guidance, it is not intended to cover all the requirements of producing software that subsequently becomes part of a medical device.
This course describes the regulatory requirements and expectations for the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. Also addressing computerized systems used to:
- Automate any part of the medical device production process or any part of the device quality system.
- Manufacture, process, pack, or hold pharmaceuticals.
- Create, modify, and maintain: A collective term for the regulations known as Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices; these regulations govern the sequential steps employed in the creation, development, and manufacture of new drugs, biologics, and medical devices.
- Regulated electronic records and manage GxP-regulated electronic signatures.
- Later courses in this series present an approach to meeting these requirements and address the inspection of computerized systems.
This overview discusses the need for validation requirements to help regulate the extensive use of computerized systems in manufacturing.
- Guiding Principle
- FDA Expectations
This course addresses the following:
- CFR Part 11 - Electronic Records; Electronic Signatures
- 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
- CFR Part 820 - Quality System Regulation
- GAMP 5: GAMP Guide for Validation of Automated Systems (A Risk Based Approach to Compliant GxP Computerized Systems), ISPE March 2008
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA CDRH January 2002
- Glossary of Computerized System and Software Development Terminology, FDA ORA August 1995
- Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures, Scope and Application, FDA, August 2003 Final Guidance
- Guide to Inspection of Computerized Systems in Drug Processing, FDA ORA February 1983
- Guidance for Industry - Process Validation: General Principles and Practices, January, 2011, rev. 1
- Software Development Activities, FDA ORA July 1987
Attendance suggested for:
- Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
- Computer system vendors or consultants, engineering contractors, and validation service companies.
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