Implementing 21 CFR Part 11 - What is Computer Systems Validation and how to Implement it
This system validation webinar training by the expert speaker will cover the Computer Systems Validation Regulations and then cover how a company complies with those regulations when they implement a computer system.
Why Should You Attend
The requirements of FDA CFR Part 11 apply to the implementation and use of computer systems that are used to manage information that is to be submitted to the Agency (FDA).
By validating the systems you are assuring that they are functioning properly and are not posing a risk to patients or others. When a submission is made to FDA it is likely that the FDA will do an inspection and they will review the process validation documentation and procedures.
Areas Covered in this Webinar
This computer system validation course will cover the procedures that are to be followed and discuss all of the documentation that is to be prepared to meet the requirements of this regulation. Typically a System Development Life Cycle (SDLC) will be used to identify the Tasks to be performed, Those responsible for the tasks including those that are Responsible for the contents, the Deliverables that are to be produced that establish the Documented Evidence that the Computer System is working as intended.
Be able to develop a Validation Plan
Contribute to the development of Specifications
Follow Programming Standards, if programming
Build and execute Test cases
Install and operate the Systems
Develop Ussr documentation
Contribute to Change Control
Who Will Benefit
IT Staff implementing and supporting these computer systems
Users of the computer systems
Quality Assurance Staff faced with auditing computer systems
Vendors of these “Regulated “computer systems
Richard Chamberlain is the President, Executive Consultant Services, LLC Consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning and Computer Systems Validation. Managed large-scale clinical projects including development and validation of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs. Taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems. Assisted in the development and validation of numerous computerized systems in all GxP environments. Assisted with the development of all varieties of Standard Operating Procedures and other required documentation for compliance to regulations. Familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs. Experience responding to FDA Inspections, 483s, and Warning Letters Use of tools such as Gap Analyses, Risk Management, and Quality Management.