This 21 CFR Part 11 training will address in detail the process for successfully managing, gathering, analyzing, specifying and documenting validation activities as well as appropriately implementing 21 CFR Part 11 regulations.
Why Should You Attend:
The quality of electronic systems for manufacturing, laboratory and clinical use is carefully regulated by the FDA through implementation of regulatory requirements. Technology is advancing rapidly and ensuring compliance and FDA requirements presents a challenge. The 60 minute webinar will focus on the requirements for proving validation compliance standards for the applications and computerized systems utilized in GXP industries.
This webinar will assist in identifying minimum validation requirements for quality of electronic systems and business critical applications for manufacturing, laboratory and clinical computerized systems. The importance of using successful validation protocols to reduce costs through risk analysis techniques and implantation of templates for standards will also be discussed.
Areas Covered in the Seminar:
- The importance of Regulatory Requirements and who must comply
- The FDA’s Perspective: 21 CFR Part 11 Compliance and Computer Validation
- Risk Analysis – How to Determine Which Systems Need to be Validation
- What are the Validation Requirements for:
- Different Categories of Software & Requirements for Off the Shelf Software (OTSS)
- Production Equipment
- Lab Equipment
- Procedural Requirements for Data Migration, User Requirement Specifications, Design Specifications
- Developing the Validation Master Plan
- Preparing Reports
- Validation Planning and Project Management
- Effective Testing
- Auditing
- Assessing the Impact of Software Changes and the Importance of Change Control
Who Will Benefit:
- Information Technology Managers & Professionals
- Quality Assurance Staff
- Quality Control Staff
- GMP, GCP, and GLP Professionals
- Regulatory Affair Managers & Staff
- Clinical Data Management Professionals
Instructor Profile:
Darlene (Dar) Douglas, is a Principal Researcher for Mentor Demographics and a Primary Contributor to the National Institute of Health Cancer Bioinformatic Grid (caBIG). She has a proven track record of successfully achieving timely global regulatory approvals, initiating and effectively managing clinical investigations as well as corrective active programs. Dar has also participated in the Compilation of the Parke-Davis/Pfizer Validation Master Plan (VAMPIRE). She shares unique insights gained from fifteen years experience in clinical trial conduct, validation, quality control, data management systems, post approval market surveillance, supplier management and regulatory compliance in the areas of biopharmaceuticals, medical devices and public utility/power generation industries.
