2nd and 3rd October 2019

Risk Management
The Elements of Computer Validation
IT Infrastructure qualification
Validation of ERP systems
Data Integrity

BACKGROUND

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 how to implement them in the real life. The Qualifi ed 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.

LEARNING OBJECTIVES

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.

TARGET AUDIENCE

This seminar is designed for Qualified Persons and Responsible Pharmacists, Quality Assurance Experts, Production Engineers and IT specialists involved in computer validation activities.

PROGRAM

DAY ONE

Laws and Regulations for CSV
The GAMP5 approach to CSV
User Requirement Specification
Workshop: How to create a good URS
Risk Management
Tools – Which are preferable for CSV risk assessments?
Risk considerations (FRA) – complex vs. simple systems
Risk Assessment Workshop
The Elements of Computer Validation
Inventory, Validation Planning, Testing, Deviations, Reporting, Periodic Review, Change Control. Hot topics for Health Authority Inspectors and Auditors
Validation of ERP systems
Elements to consider to validate an ERP system.
Electronic Records and Electronic Signatures
21 CFR Part 11

DAY TWO

IT Infrastructure qualification
Processes and critical areas
Data Security and Data Privacy
Expectations from IT Service Providers
Cloud Computing
How to bring the Cloud in the state of control?
Data Integrity
How to integrate Data Integrity in the CSV Process
What needs to be updated in order to be compliant?
Second Person review, Audit Trail Review
Supplier Audits
Hot buttons for supplier and service provider audits
Workshop: Preparing for a System Supplier Audit
How to prepare for a Regulatory Inspection
How to present your computer systems to the regulators
Health Authority findings

SPEAKER BIOGRAPHY:

Dr Wolfgang Schumacher

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.

FEES (per person, VAT not included)

EARLYBIRD TICKET – 900 BGN (available until 02 August 2019)
REGULAR TICKET –1250 BGN
Bulgarian QP Association member – 1050 BGN
Two or more delegates from one organization – 1050 BGN/ per person
The seminar fee is payable in advance and includes training documentation, lunches and refreshments.

REGISTRATION

Via the registration form
http://bit.ly/bgqpacom

DATE

Tuesday, 02 October 2018 (9:00h -17:30h)
Registration and coffee 8:30 – 9:00h
Wednesday, 03 October 2019 (9:00h – 17:30h)

VENUE

Hotel GRAMI
1712 Sofia, #79G Alexander Malinov blvd.
www.gramihotelsofia.com
reservations@gramihotelsofia.com
Phone  +359 2 4349111; +359 885 304 200; +359 2 4349115
BGQPA has reserved a limited number of rooms in the conference hotel. Reservation should be made directly with the hotel. Early reservation is recommended.

ORGANIZATION AND CONTACT

For questions please contact us:
bulgarian_qp_association@abv.bg
www.bgqpa.com
Mob +359886594949


DOWNLOAD the brochure in pdf