Computerized Systems - Annex 11 Revision, Data Integrity and the Quality System

Computerized Systems – Annex 11 Revision, Data Integrity and the Quality SystemInteractive Workshop

Expert Lecturer: Ms. Karen Taylor (Ginsbury)

Categories: Quality

SKU: 25808

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The classroom has been filled, online participation via Zoom only Annex 11 Computerized Systems is being updated. A 32 point, five page concept paper has been issued for comment. Of 32 points raised, NONE is addressed in the existing 5 page annex. Based on other GMP chapter / annex revisions, we can expect from 60 – 80 pages...Continue reading

The classroom has been filled, online participation via Zoom only

Annex 11 Computerized Systems is being updated. A 32 point, five page concept paper has been issued for comment. Of 32 points raised, NONE is addressed in the existing 5 page annex. Based on other GMP chapter / annex revisions, we can expect from 60 – 80 pages of detailed requirements for computerised systems in a GMP environment. There are many Data Integrity guides. 483 findings, warning letters appear at an alarming rate with the same findings over and over. The objective of this workshop is to understand what is really needed for the installation, qualification and lifecycle control of computerised system, including in-built Data Integrity safeguards.

Course Instructor
This course will be presented Karen Ginsbury, CEO of PCI Pharmaceutical Consulting Israel Ltd. Karen has over 30 years’ experience in the pharmaceutical industry and has worked closely with:

Virtual companies and multi-nationals to develop flexible but compliant quality systems for the manufacture and control of IMPs
API and finished pharmaceutical manufacturers to set-up, maintain and improve their GMP compliant quality systems
Outsourced operations setting up and implementing quality systems which meet the needs of the Contract Giver and Contract Acceptor

In this course she will bring you her experience and case studies to help understand how a effective management of computerised systems from design through lifecycle use, can overcome data integrity issues and cause a real improvement in the control of GxP critical data.

Date: 27 October, 2025

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Course location: Hybrid: Kiryat Weizmann Ness Ziona or ZOOM

Duration: 1-Day Course

Hours: 09:00 - 17:00

Credits: 1

Course Language: עברית

Course price: 1,950 NIS + VAT

Early registration discount until 19 October, 2025:
1,755 NIS + VAT.

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Issues to be covered

PIC/s Concept Paper on revision of Annex 11 What awaits industry in future inspections?
Inspection / Audit findings and Warning letters We all have this problem…
Brief review of Regulatory Guidance:
- WHO Data Integrity Guideline
- FDA Guidance: Data Integrity Q&A 2018
- MHRA Data Integrity Guidance
- PIC/s: Data Integrity in Regulated GMP/GDP Environments
- EMA Q&A on Data Integrity
- WHO Good Data and Record Management Practices
Interactive Group Activity: develop checklist for oversight of computerised system service providers
Quality Unit role vs rest of management
Effective Internal Audits for Data Governance

Who should attend

This course is suitable for:
Executive management in virtual companies obtaining data from outsourced operations. Anyone working in the pharmaceutical industry including Company General Managers, Managing Directors, VPs, QPs, Quality Assurance, Quality Control and other quality professionals, Operations Managers, production managers, Research and Development, persons working in technology transfer, personnel working in pharmaceutical Active substance and finished product manufacture as well as distributors, brokers, wholesale dealers and anyone involved in the manufacture of starting materials, Active Substances, finished pharmaceuticals or involved in the handling, processing or sale or administration of any of these. Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course very useful as will regulatory personnel.

Benefits to the Participants

Participants will come away from this course understanding:

What is a GMP-impact computerised system
Data integrity issues from recent 483 and warning letters what is a real problem and what is background noise?
How data integrity lapses happen
How to work with and effectively oversee computerised systems service providers: what does YOUR company need to do?
How to integrate automated / digital and digitized solutions to reduce dependence on humans and eliminate human error

About The Lecturer

Karen Taylor (Ginsbury)

B.Pharm, M.Sc, MRPharmS, has over twenty five years of experience