Computer Systems Validation – GAMP 5 Training Course (Includes GAMP 5 second edition updates)
This computer systems validation training course covers the essential principles on how to use a risk-based approach in Computerised Systems Validation (CSV) and now includes GAMP 5 second edition, including the new chapters on Artificial Intelligence, Machine Learning, and Blockchain) as well as recent developments, i.e. FDA’s draft Computer Software Assurance (CSA) Guideline, and of course the PIC/S Data Integrity guidance PI041. Aside from shifts in regulations, there have been significant technological shifts too, as part of Pharma 4.0TM, we have Software as a Medical Device (SaMD) and Software in a Medical Device. The computer systems validation course will cover both medical device and medicine regulations and recent challenges posed by emerging technologies like IoTs.
Whilst this course started out being heavily focused as a GAMP5 Training Course, the scope and application have since been broadened. Due to the update of GAMP5 second edition, the course will include the latest principles as well the updated draft ICH Q9, the FDA’s draft Computer Software Assurance Guidance.
This course offers a high-level compliance review of the broad, ever-changing GMP requirements, i.e. PIC/S guidelines, Annex 11, and the US FDA and EU Data Integrity guidance’s (as examples) and will touch on device regulations, such as ISO13485, IEC62304, ISO14971, and comparable FDA requirements, CFR 820. It is designed for busy pharmaceutical or medical device professional seeking training on a practical and cost-effective validation approach in the pharmaceutical, medical device and veterinary industries.
By following a practical 3 step approach, this course will help ensure compliance.
- Understanding the predicate rules, i.e. the GMP requirements,
- Embracing a risk-based approach,
- Then, with an excellent understanding of various CSV methodologies including those in the ISPE Good Automated Manufacturing Practice (ISPE GAMP5) guidance, the waterfall, IEC 62304, EU & PIC/S guidance, Annex 11, and the US FDA CFR Part 11 Electronic Records: Electronic Systems.
ISPE, GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems states:
There are major business benefits in having a defined process that delivers systems that are fit for intended use, on time, and within budget. Systems that are well defined and specified are easier to support and maintain, resulting in less downtime and lower maintenance costs.
What you will learn in this Computer Systems Validation/GAMP5 training course
After completing this Computer Systems Validation / GAMP5 based training Course, participants will:
- gain a thorough understanding of the GMPs and the impact of recent Data Integrity issues
- understand Electronic Records and Electronic Signatures (ERES) and a complete understanding of the EU, PIC/S PE 009 Annex 11 and US FDA CFR Part 11 compliance
- data integrity drivers and how that is impacting on CSV approaches,
- be able to use the ISPE GAMP 5 risk-based approach to reduce qualification and validation costs
- know how to write and structure a User Requirements Specification, Functional Specification and Design Specification using the risk-based approach
- know what a design review/qualification is and when it is used
- know how the validation v-model applies to GxP computerised systems
- be able to plan scalable validation processes according to patient safety, product quality and data integrity priorities
- know how to direct computerised validation projects
- understand the major life cycle phases of computerized systems, from concept to retirement
- understand software categorization and the qualification and validation efforts required for various computerised systems
- understand the decision process: selecting off the shelf, customised or totally novel computerised systems
- understand computerised system validation from a regulator’s perspective
- be able to identify key validation deliverables
- know how to leverage supplier involvement to reduce duplication, commonly found in the ISPE GAMP 5 approach.
Participants will receive a workbook with will contain a copy of the presentation(s), relevant notes and workshop materials. A certificate of completion will be issued to participants who successfully complete the assessment.
A written assessment (and/or online assessment) is conducted at the end of the course.
This Computer Systems Validation and GAMP5 Training Course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.
Who should attend this CSV and GAMP5 training course?
- Validation Professionals
- Quality Assurance personnel
- Operations or Manufacturing personnel
- IT personnel
AUD$500.00 + 10% GST Full Day Virtual Training
AUD$550.00 + 10% GST Full Day Classroom Training
Prices are per person. Currently offered via ZOOM (live-streamed).
When conducted in person (pending lockdowns), may include morning tea, lunch and afternoon tea (excluded for Virtual/live-streamed training sessions).
Register for Computerised Systems Validation – GAMP5 Training Course below:
If you need any assistance, would like a quote for personalised group training or just have a general training question don’t hesitate to contact us at one of our offices around the world.
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