 Web Seminar: Understanding and Implementing the New EU Annex 11This web-seminar will discuss how to prepare Pharmaceutical companies marketing products in Europe for upcoming Annex 11 inspections. Attendes will receive 10+ best practice guides for easy implementation.
By: Labcompliance Sept. 20, 2012 - PRLog -- Why to attend:
After more than 15 years the EU has released a new version of Annex 11. It has been in effect as a regulation since July 2011 but only recently EMA started to enforce the Annex. Together with the updated EU Chapter 4 on documentation it is the EU equivalent to FDA's Part 11. It also addresses the regulatory needs of modern IT equipment and when implemented right, also has business benefits through reduced failure rates. The document is a good framework for validation and use of computer systems and handling electronic records in different regulated environments. And if Annex 11, like the previous version, becomes a PIC/S guide it will have a high impact on more than 30 countries, including USA and Canada. On the other hand the Annex leaves a lot of room for interpretation that raises lots of questions. This seminar will have the answers. During the seminar, the speaker will go through requirements and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help trouble-free implementation. Areas Covered in the Seminar: * History, status and future of the Annex 11 * Relation to other documents: GAMP5 ®, Part 11, Annex 15, PIC/S * New expanded scope of Annex 11 * Justification and documentation of risk assessment * The responsibility of the process owner and system owner * Supplier management through formal agreements * Requirements for validation throughout the lifecycle * Considerations about using automated test tools * Management of electronic records from acquisition to archiving * Definition of raw data * Adequate handling electronic signatures * Requirements for back-up, incident management and business continuity * The role of the Qualified Person for automated systems * Recommendations for implementation And for easy and instant implementation: download 10+ documents from special seminar website. They include * PowerPoint Presentation * Script * Computer System Validation Master Plan (30+ pages)Ten example * SOP: - Risk Based Validation of Computer Systems * Validation of Commercial Off-the-shelf Computer Systems * SOP: Quality assessment of Software and Computer System Suppliers * SOP: Validation of Spreadsheet Applications * SOP: Data Back-up and Restore * Change Control of Software and Computer Systems * Disaster recovery of Computer Systems * Auditing Computer Systems * Training for Computer Validation * Access Control to Computer Systems and Data * Gap analysis: Annex 11 * Worksheet: Detailed comparison: Annex 11 - Part 11Validation * Example: Identification of Network Infrastructure and Systems * Requirement Specifications for Electronic Signatures. Date: December 20, 2012 Time: 11.00 - 12.00 a.m. ET Location: Online, worldwide Who should attend * IT managers and staff * QA managers and personnel * Qualified persons * Site and operations managers * Users of regulated computer systems and records * Software Developers * Validation specialists * Regulatory affairs * Training departments * Documentation department * Consultants Weblink: http://www.labcompliance.com/ Category: Pharmaceutical, GMP, API Manufactuer, FDA, EMA, Training, Annex 11 Presenter: Dr. Ludwig Huber Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the global on-line resource for validation and (laboratory) End
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