Practical Computerized System Validation Under Scope of GAMP-05 and MHRA GMP Data Integrity

Description of the Seminar

In this seminar;

  • Explaining FDA, EU Annex 11 requirements under GAMP-05’s scope.
  • Describing Computerized Systems Validation’s requirements with case studies.
  • Creating a plan to update Computerized Systems Validation and electronic raw data management procedures and instructions.
  • Understanding expectations of Health Ministries (MoH, FDA, MHRA and EU).
  • Impact of data integrity and data management on computerized systems validation based on ICH Q9 quality risk management approach will be explained in this seminar

Aim of the Seminar

Following terms will be explained in this seminar

  • Basics of Computerized Systems’ Validation
  • EU Annex 11 Electronic Record and Electronic Signature Approach and 21 CFR Part 11
  • Comparison between GAMP 05 and EU Annex 11
  • Risk-relation between data critic and data integrity
  • Ensuring data quality and integrity in the design stage of systems
  • Data, Raw Data, Meta Data,
  • Data Integrity, Data Management, Data Life Cycle???
  • First Record, Original Record, Real Record
  • Computerized System Applications
  • Audit Trail, Data Check
  • Data Storage
    o Back-up
    o Archive
  • Data Files Format
    o Plain Text Documents
    o Relational Databases

Participant Profile

  • Computerized Systems’ Validation Personnel
  • IT Personnel (Internal or External)
  • Computerized System Owners in Production and Analytic Laboratories
  • Engineers
  • Quality Assurance and Inspection Personnel who checks Validation Data
  • GMP Software Applications Suppliers

Agenda

First Day

09:00 – 09:30 : Registration
09:30 – 10:30 : Foundations of Computerized Systems’ Validation
10:30 – 11:00 : Break
11:00 – 12:00 : FDA and EU Annex 11 laws
12:00 – 13:00 : Team Work
13:00 – 14:00 : Lunch
14:00 – 15:00 : Good Automated Manufacturing Practice (GAMP) Spelling
15:00 – 15:30 : Break
15:30 – 16:30:  Comparison between GAMP 05 and EU Annex 11
16:30 – 17:30 : Team Work

Second Day

09:00 – 10:30 : BSV Strategies
10:30 – 11:00 : Break
11:00 – 12:00 : 21 CFR Part 11
12:00 – 13:00 : Team Work
13:00 – 14:00 : Lunch
14:00 – 15:30 : MHRA GMP Data Integrity and Definitions Policy
15:30 – 16:00 : Break
16:30 – 17:30 : Data Integrity and FDA Warning Letters Concerning BSV

Instructor

Timur Kabadayı MSc, MBA

Managing Director and Consultant of Conval Group Timur Kabadayı has nearly twenty-six years of experience in pharmaceutical industry. Switching from being Maintenance Director of Eczacıbaşı Pharmaceuticals’ Lüleburgaz facility to Computerized Systems’’ Validation in Canadian corporation Apotex, he changed the course of his life and became Division Manager almost instantaneously. In 2004, he founded Conval Group. With his team, he runs CSV projects domestic and international with success. Timur Kabadayı is a Certified Mechanical Engineer, he finished his MBA in York University, Toronto.

Seminar Location and Registration

Seminar Location: Conval Grup Egitim Salonu
Kanlıca Mah. Hacı Muhittin Sok. No:35 Beykoz İstanbul

Seminar Registration:
Registration Price: 600 EU + KDV (Included in Price: Seminar documents, seminar certificate, lunch and tea/treat supply for all day)
Contact: Elvan Çimen- (0 544 290 98 13) elvan.cimen@convalgroup.com

Payment Info 
Account Name: CONVAL GRUP VALİDASYON EGİTİMİ VE DANISMANLIK TİC. LTD. STİ.
Bank: AKBANK
Branch: Gayrettepe (287)
TL IBAN: TR11 0004 6002 8788 8000 0762 87
EUR IBAN: TR92 0004 6002 8703 6000 2088 48