GxP Computerised Systems

Description

Learn what’s required to comply with Computerised Systems standards in GMP environments.

GxP Computerised Systems – Regulatory Requirements

The course will provide you with a helpful cGMP training resource for GxP computerised systems. It covers GXP Computerised System regulatory compliance requirements and industry standards (including ISO standards for automated/computerised systems used in pharmaceutical manufacturing), provided in a convenient, fully-online Certificate GMP course.

Course Compatibility with GxP Industry Standards

This computerised systems course is compatible with the following life sciences industry guidance publications for computerised systems:

• ISPE (GAMP^®5) – 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

It is useful for anyone who needs an introduction/refresher course to better understand their GxP compliance responsibilities.

GxP Computerised Systems

cGMP Guidance for Industry: Requirements for Computer System Validation (CSV), Verification, and Risk Management

• This GxP compliance course is one of our many GMP training materials/online courses available in a self-paced GMP eLearning format
• It is available to complete at any time after purchase (24/7) via an internet connection and your login details (one user per licence)
• This cGMP (GxP/GMP) education topic is a follow-up to other courses, including courses that cover compliance with medical-device ISO standards)

Online GMP training & Classroom Options

• Click here for a list of face-to-face courses delivered via Zoom or via classroom style learning
• Onsite training of large groups of personnel may also be available, where feasible

Who needs GxP Computerised Systems Regulatory Compliance Training?

• Employees who are responsible for choosing, validating, testing, using, or maintaining software, hardware, and other computerised systems components in GxP/GMP environments.
• Personnel using computerised systems in GxP/GMP environments, including purchasing agents, personnel and contractors.
• Companies whose GxP computerised systems will be audited by the FDA, TGA, EMA, MHRA, and other regulatory authorities

Can anyone take this GxP/GMP online training course?

• Yes, anyone can complete this course upon purchase and registration.
• 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.

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.

GxP Computer System Responsibilities (Careers)

Individuals working in the following roles generally require compliance training for GxP Computerised Systems including PIC/S Annex 11 and ISPE GAMP^®5.

Personnel with any of the following responsibilities will benefit from taking this GxP/GMP computerised systems compliance course.

• Computer system specification development in cGMP environments
• 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

Job roles/positions for course attendees for this GxP/GMP education topic include, but are not limited to:

• 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 GAMP^®5 (2nd Edition)
  • FDA CFRs/Data Integrity
  • Sponsors/Clinical Trials guidance for computerised systems

This online GXP/GMP course is best combined with our Data Integrity training course, Supplier Qualification courses, and Batch Release training modules. Explore the online GMP special training bundles (combined training packages).

Completing this Course to gain your GxP/GMP Certificate

Successful completion of our online cGMP courses provides you with a Certificate of Completion for your personnel records and/or job application CV (your resume).

cGMP training course bundles are available.

• You can purchase this course individually and/or in a training bundle.
• Purchasing several courses at one time helps you save on your training budget.

Visit the online GMP training store or search ‘bundle’ to learn more.

• Learners will gain 12 months’ access to the fully-online course
• A downloadable Certificate of Completion is available for this education topic upon successful completion of the course (a single course purchase means one person only can complete a course per purchase); note that logins to online cGMP training courses should never be shared

GxP Regulatory Compliance Training (GMP)

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 (using a credit card to complete your cGMP training purchase.
• If you’re purchasing this course for yourself and your future career in the pharmaceutical industry, consider the customisable 4 course bundle or 6 course bundle (packages)

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Note: All course prices are in US dollars. 

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.

Pharmaceutical Industry training: GMP certificate courses

•  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.
• Review other top-ranked GMP courses and best-practice GMP training courses.

How to complete this course.

• Add the course to your basket and complete your purchase.
• One user/per licence purchase (12 months’ access).
• 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”.
• This GxP Computerised Systems regulatory compliance training is available fully online (24/7 access).

GxP Computerised Systems (Course Summary)

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.; including understanding the need to comply with ISPE GAMP^®5, PIC/S Annex 11, Data Integrity, and other relevant GMP requirements.