Pharmalex Bulgaria and the Bulgarian Association of Qualified Persons would like to invite you to:
Essentials of Computer Systems Validation
2-3 OCTOBER 2019
Hotel Grami, 79G Alexander Malinov Blvd., Sofia, Bulgaria
The current GMP regulations and guidelines (ICH Q9, GAMP®5, EU GMP Guide Annex 11 “Computerised Systems“) focus more and more on the topic of computer validation, data integrity and cloud computing, but not providing practical guidance on how to implement them in real life. The Qualiﬁed Persons, Responsible Pharmacists, Quality Assurance and IT specialists have a lot of obligations related to computer validation, CS risk management, computer supplier approval, data integrity and audit trails. Therefore, it is the aim of this course to provide you with practice-oriented guidance in performing these tasks.
The aim of this two-day seminar is to provide a review of current EU regulation related to computer system validation, to give a proactive advice on to implement all requirements in the real life in an effective and GMP compliant way. Several interactive workshops will be provided throughout the two days which will enable delegates to understand and discuss the concepts in more detail, and to be able to apply what they have learned.
This seminar is designed for Qualiﬁed Persons and Responsible Pharmacists, Quality Assurance Experts, Production Engineers and IT specialists involved in computer validation activities.
Early Bird Ticket
Available until 02 August 2019
Bulgarian QP Association member
1050 BGN per person
Two or more delegates from one organization
The seminar fee is payable in advance and includes training documentation, lunches and
Dr Schumacher studied Pharmacy and Chemistry at the University of Heidelberg, Germany. After his thesis at the Max-Planck-Institute for Medicinal Research he joined ASTA Medica Frankfurt in Oncology research where he filed a number of patents for novel anticancer agents. After several project assignments he entered Quality Assurance, heading the GMP compliance international department. There he escorted numerous FDA inspections and managed the internal GMP audit function. He also assumed the QP accountability for contract manufacturing.
In 2001 Dr Schumacher joined F. Hoffmann-La Roche Ltd in Basel as Head of the Informatics Quality department with subsequent promotion to Vice Director. In 2010 he was assigned to the Head of Computer System Quality in Technical Operations. From 2015 he was leading the global Data Integrity initiative until his retirement in August 2016. From 2002 until 2009 he was lecturing as associate professor at the University of Bonn, Pharmacy Faculty, Regulatory Affairs.
In the last 25 years Dr Schumacher has trained numerous individuals in seminars, conferences and inhouse training courses in general GMPs, computer validation, risk management and data integrity. Participants always like his ability to pinpoint the essentials and his pragmatism to ﬁnd the best possibilities for solutions to meet the regulatory expectations. In August 2016, he started working as a freelance consultant.