21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Reduce the Occurrence of 483s

Duration: 90 Minutes
This webinar will discuss developing procedures for meeting Part 11 and Annex 11 requirements; Standard Operating Procedure for systems development and maintenance; Standard Operating Procedures for step-by-step activities; measure quality and demonstrate compliance to 21 Part 11 and Annex 11; and produce quality records.
21 CFR Part 11 and Annex 11 Compliance
Product ID: 501053

During the last several years, the FDA has increased its emphasis on Quality. At the same time New Technologies are changing the way many things are done in the Pharmaceutical, Medical Device industries. This has increased the importance and use of 21 CFR Part 11 and Annex 11. It is vital that the industries keep their procedures and practices up to date.

Areas Covered
  • The role of the various documentation
  • The role of SOPs in the preparation and management of that documentation
  • The organization of processes and sub-processes that require SOPs
  • How to prepare necessary systems development SOPs
  • The content and format of those SOPs
  • The responsibilities of the various stakeholders
Why Should you Attend
This course will put you in a position to better comply to 21 Part 11 and Annex 11 Requirements. It will also make it possible to demonstrate compliance.

Objectives of the Presentation
  • How to organize the development and support of computer systems
  • How to develop SOPs that can help this task
  • The development of training modules to support the SOPs
  • The production of "products" that document systems requirements, design, testing, and others
  • How to apply change control
  • Who are and what are the roles of the various stakeholders?
Who can Benefit
  • Quality Assurance Staff
  • Auditors
  • Subject Managers
  • IT Staff
  • Regulatory Affairs
$375
Recorded Session for one participant
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  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Richard Chamberlain's experience includes consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation. He has also managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.

Apart from these Mr Chamberlain has 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 Quality Management and Compliance to Regulations. He is also familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs.
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