Computerised Systems Validation – GAMP 5 Training Course
This computerised systems validation training course covers the essential principles on how to use a risk-based approach in Computerised Systems Validation (CSV). Whilst course started out being heavily focused as a GAMP 5 Training Course the scope and application has been broadened.
This course offers a high level compliance review of the broad, ever changing GMP requirements, i.e. new PIC/S Version 13, Annex 11, and the US FDA and EU Data Integrity guidances to list some. It is designed for busy professionals 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 the course will help your 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 (GAMP®5) guidance, the waterfall, IEC 62304, , EU & PIC/S PE 009 version 13, 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
After completing this Computer Systems Validation / GAMP® 5 based Training Course, participants will:
- have a through 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 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 is conducted at the end of the course.
This Computer Systems Validation and GAMP 5 Training Course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.
Who should attend?
- Validation Professionals
- Quality Assurance personnel
- Operations or Manufacturing personnel
- IT personnel
AUD $450.00 + 10% GST
Prices are per person and include morning tea, lunch and afternoon tea (excluded for Virtual Training).
Register for Computerised Systems Validation – GAMP 5 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.
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