Attend this webinar to get a condensed overview of 21 CFR Part 11 and the key practices that deliver the best results. It will direct you to the most critical and cost-effective methods, techniques and tools available.
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.
There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.
Why Should You Attend:
You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that uses ER/ES capability, or if you are maintaining or supporting such a system.Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.
There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.
Learning Objectives:
- Learn about 21 CFR Part 11 and what is required for compliance
- Learn about industry best practices related to compliance and computer system validation
- Understand strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11
- Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
- Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
- Learn how to gain information about trends in validation, as industry progresses and new best practices emerge
- Understand some of the industry best practices to apply when following the SDLC methodology
Areas Covered in the Webinar:
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- Good 'Variable' Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
- Validation Strategy that will take into account the system risk assessment process
- FDA's 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance
- Strategic Approach to ER/ES Compliance
- Policies and Procedures to support GxP compliance with 21 CFR Part 11
- Training and Organizational Change Management best practices to help move the organization in a new direction
- Industry best practices and common pitfalls
- Recently asked question ?
- Is Adobe application falls under Part 11?
Who Will Benefit:
- (Bio)Pharmaceutical Companies
- Device manufacturers
- Manufacturers of pharmaceutical starting material
- Clinical Laboratories
- Software developers
- IT managers and system administrators
- QA managers and personnel
- Users of computer systems in FDA regulated environments
- Validation professionals
- Training department
- Documentation department
- Consultants
Course Provider
Don Hurd,
