Implementing Validation and Qualification - Annex 15 and FDA Requirements

Duration: 60 Minutes
In this webinar, we will cover the role Annex 15plays in Validation and Qualification. We will discuss other related documents that provide for other aspects of what Annex 15 is covering including FDA requirements. The subject of Validation applies to chemical processes, manufacturing processes, computer processes, product approval processes and others. The tools used for validating these processes are quality management, project management, risk management and product life cycles.
Validation and Qualification
Product ID: 501423
The changes to Annex 15 are significant and represent an updated understanding of the lifecycle approach to qualification and validation by the EU in comparison to the original release in 2001. Various sections have been modified and added, resulting in a new framework that establishes process knowledge and risk assessment as the foundation for a successful qualification and validation effort.

Objectives of the Presentation
  • How to organize the Development and Support the processes used
  • How to include Quality in the processes
  • How to develop written procedures that can help this task
  • The development of Training Modules to support the SOPs
  • The production of "Products" that document the processes
  • How to apply Change Control
  • Who are and what are the roles of the various Stakeholders?
Why Should you Attend
With the increased use of new technologies, most of these processes are undergoing changes that must be recognized and managed to maintain the Quality and Integrity of the products produced by these processes. Some of these changes represent new practices that require new approaches to the regulatory requirements. Often these new technologies are changing as they are implemented and the changes must be managed in an accurate and timely fashion.

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
  • How to use Quality Management and Risk Management
  • The content and format of SOPs
  • How to comply with these changes
  • The role that each person plays in quality
  • The responsibilities of the various stakeholders
Who can Benefit
  • Quality Assurance Professionals
  • Computer Application and IT Infrastructure Staff
  • Project Managers who manage the use of the Processes
  • Operation managers and staff
  • Auditors
  • Compliance Professionals
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants
Topic Background
During the last several years, the FDA and EU have increased their emphasis on Quality. At the same time New Technologies and new Regulations 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 and Annex 15. The new Annex 15 on Validation and Qualification replaces the existing version from 2001. It has been significantly updated to be in line with other modern guidance's such as ICH Q8/9/10/11 and has components from Quality by Design, Risk Assessment and Quality Systems. So every company marketing APIs and drugs to Europe and to other PIC/S member countries should comply. It is vital that the industries keep their procedures and practices up to date.
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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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