GXP – Good Practices
- In-person Course Delivery – Live Training Sessions
- Attendance for 3 Days Training
- Guided Learning Hours – 12
- Case Studies, Exercises, Q & A,
- Pre-Course Access: Pre-Event Questionnaire, Presentation Slide Deck
Course Overview
This 12 hrs online expert course covers GXP aspects for Computer System Validation (CSV) and Data Integrity (DI). The 3 Day sessions also cover the baseline for digitalization projects, digital validation, qualification of cloud computing used in the GXP environment. It contains a full session about the validation of artificial intelligence (AI), deep learning and machine learning (ML).
All applicable world-wide regulations will be introduced, including but not limited to EU GMP Annex 11 and US-FDA 21 CFR Part 11 – ERES and others. Learn about the background, effects and details regarding the current changes and extensions of the ISPE GAMP®5 – Second Edition – which was released in August 2022.
Trainer’s Profile
Markus Roemer is an independent consultant, involved in a wide range of areas including the validation of computerised systems, auditing, quality management, project management and compliance management. Since 2008, he has been working as an ISPE ambassador for the DACH affiliate.
Markus Roemer is a frequently invited speaker and trainer by organizations such as PTS (pharmaceutical training services), ISPE, European Compliance Academy and the European QP Association at more than 100 events or training. In his current position as Managing Director at comes compliance services he oversees consultancy services for IT and PQS
compliance. Mr. Roemer has written widely about computer system validation and the use of electronic systems (eDMS, EBR, ERP) and is also the author of several books on validation, IT compliance, GMP documentation and processes.
Key Takeaways
By attending this course, delegates will:
- Identify CSV and DI Requirements
- Understand validation projects and goals
- Lifecycle data and system lifecycle
- Operational understand what and how to do it – and why
- Integration use it in your daily business
- Build a landscape and roadmap to compliance
Who Should Attend
- Senior Management / CEO
- Qualified Person / Responsible Person
- Head of QA, Production and QC
- Validation and Qualification Teams
- Inspectors and Investigators
- Validation Experts
- People willing to be a game changer in the company
For participation details contact
Mithun Siddartha
+1 780 851 7197 (Canada)