GxP Computerised Systems
Course duration: Allow 2 to 4 hours to complete this course.
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Learn what’s required for GxP Computerised Systems in our fully-online Certificate GMP Compliance course.
GxP Computerised Systems – Regulatory Requirements
The course provides learners with a helpful resource pertaining to regulatory guidance for GxP computerised systems.
It is compatible with the following industry guidance documents for computerised systems:
- ISPE (GAMP5) – Guidance for GxP Computerised Systems
- PIC/S Annex 11 – Computerised Systems Guidance
- FDA guidance for GxP compliance – computerised systems
- EMA guidance for GxP compliance – computerised systems
GxP Computerised Systems – Industry Guidance
Computer System Validation (CSV), Verification, & Risk Management Requirements
About this GxP compliance course:
- This is one of our many GMP education topics eLearning courses available 24/7.
- It is a follow-up course to medical-device relevant ISO standards training course(s) listed previously on this page.
- Click here for a list of face-to-face courses delivered via Zoom, including CAPA (onsite training of large groups of personnel may also be available, where feasible).
Who should take this GxP Computerised Systems Regulatory Compliance Training Course
This course is suitable for a wide range of employees in the Pharmaceutical and Medical Device industries. It is also suitable for individuals who work with computers involved in Clinical Trials.
It is useful for anyone who needs an introduction/refresher course to better understand their GxP compliance responsibilities, including during:
- Computer system specification development
- Computer system design, system development & coding phases
- Configuring software
- Verifying/testing software to ensure it is fit for use & meets regulations
- Conducting Computer System Validation (CSV) activities
- Validating and maintaining computerised systems
- Ensuring Data Integrity/appropriate data governance measures
This GxP guidance applies to computerised systems used for various medicinal product business functions, including new drug development processes, manufacturing, batch traceability, storage & distribution, and other functions.
Intended course audience:
- Business owners/Sponsors & Manufacturing SMEs
- Computer systems decision-makers
- Pharmaceutical Industry IT personnel
- Quality Unit personnel
- Operations teams and Management
- Training Program Managers
- Process owners
- System owners
- Individuals needing to better understand industry guidance such as:
- PIC/S Annex 11 – Computerised Systems
- ISPE’s GAMP5 (2nd Edition)
- FDA CFRs/Data Integrity
- Sponsors/Clinical Trials guidance for computerised systems
This online GMP/GXP course is best combined with our Data Integrity training course, Supplier Qualification courses, and Batch Release training modules.
Purchasing several courses at one time helps you save on your training budget. Alternatively, you can purchase a single course, or just a few of the courses you need, to engage in ‘just in time’ learning.
- Learners will gain 12 months’ access to the fully-online course and a downloadable Certificate of Completion for this education topic.
- A single course purchase means one person (only) can complete that course.
- Computer logins to online training courses should never be shared.
Do you need to train your personnel to comply with Regulatory Compliance requirements?
- If you need to train large numbers of employees (e.g. 50 to 1000 employees, or more), contact us for a custom quote.
- You can alternatively order discounted GMP education topics/GMP training bundles.
- If you’re purchasing this course for yourself and your future career in the pharmaceutical industry, consider the customisable 4-bundle course packages.
Note: All course prices are in US dollars ($35 USD is equivalent to approximately $55 AUD).
Bundled training options let you ‘mix and match’ standard GMP compliance training courses and/or assign courses to different employees when required (enabling ‘just in time’ GMP training). All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.
About this Pharmaceutical Industry training course
- Completion of any of our online GMP courses will enable you to print your GMP topic Course Certificate’
- Some courses enable you to also earn a Credly badge for your social media channels (not all courses include a Credly badge, yet all courses give you an A4 printable Certificate of Completion for framing and for your personnel records).
- You can also attach your GxP Computerised Systems course Certificate of Completion to your CV when applying for new job openings in the pharmaceutical manufacturing or medical device sector.
How to complete this course.
- Add the course to your basket and complete your purchase.
- Remember, the course fees are listed in US Dollars.
- Check your emails (all folders) for log-in instructions approximately 5 to 10 minutes after your order is finalised.
- Be sure to search for/add the following domains to your safe sender’s list: “@onlinegmptraining.com” and @pharmout.net”.
One user/per licence purchase (12 months’ access)
- This GxP Computerised Systems regulatory compliance training course is available fully online (24/7 access).
- One learner (user) per licence.
- Course completion provides learners with a foundational understanding of the key elements of GxP requirements for all types of computer systems used in manufacturing, storage, distribution, batch tracing, etc.
Allow 2 to 3 hours to complete this eLearning training course including completing the online Final Assessment to gain your Course Certificate.