Annex 15 – Qualification and Validation

Description

Online GMP Training topic: Regulatory compliance with PIC/s Annex 15 – Qualification and Validation (applicable to EU Annex 15 Qualification & Validation).

Comply with PIC/S Annex 15 – Qualification and Validation

What does PIC/S Annex 15 training cover?

• PIC/S Annex 15 covers regulatory compliance requirements (cGMP requirements) for the qualification and validation of GMP facilities, systems, utilities, and processes.
• This EU & PIC/S Annex 15 eLearning is suitable for validation contractors, pharmaceutical engineers, and quality management personnel who work in GMP facilities.

This PIC/S Annex 15 (GMP training presentation) will help you understand:

• Organisation and planning of validation activities including the Validation Master Plan (VPM)
• Common Qualification and Validation terms and definitions
• Principles of qualification and validation including validation & verification essentials
• Phases of Qualification, e.g. Design Qualification (DQ), User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
• Process Validation essentials
• Importance of Change control systems
• Requirements for ongoing monitoring of the validated status
• Requirement for documented cleaning validation
• Validation over the product life cycle
• Validation Models and sequences
• The basic V model vs ASTMA E2500 approach to validation in the pharmaceutical and life sciences sectors
• References and resources (links to ISPE, FDA guidance, EU guidance, etc.)

GMP Certificate Course for Annex 15 – Qualification & Validation

• This interactive e-Learning Annex 15 qualification and validation training course provides participants with an understanding of GMP regulations pertaining to qualification and validation requirements for facilities, equipment, utilities and processes including cleaning validation.
• After successfully completing this online GMP training course covering Annex 15 Qualification & Validation/GMP requirements, you can save and print a personalised GMP Training Course Certificate which meets regulatory GMP requirements.
• Your GMP Training certificate should be kept in your personnel training record file and be included with your CV when applying for jobs in the pharmaceutical manufacturing and life sciences industries.

Suggested courses to supplement this GMP training presentation:

• GMP Industry – Cleaning Validation requirements
• Pharmaceutical Manufacturing Fundamentals (PMF Series) including Pharmaceutical HVAC, Pharmaceutical Water Systems, Contamination Controls and Pharmaceutical/API Product Containment

For other GMP courses (online GMP training options), visit the GMP education topic pages.

GMP education purposes only.

Single-user licence. Consider the training bundle options (GMP training program packages) if purchasing more than one course.

How to complete this PIC/S Annex 15 training course for Qualification & Validation

• Scroll up to add this purchase to your basket (top of page)
• Complete your purchase (complete the checkout process)
• Then check your emails a few minutes later (including searching your filtered folders) for an email containing your GMP training course login details (which should arrive fairly quickly in your email INBOX)
• Please ensure you use your correct email address
• If you don’t see this login information email in your INBOX, search your mailbox folders for ‘onlinegmptraining’ and/or search for the words ‘course’ and/or ‘Pharmacovigilance’
• Once you locate this email, log in and begin your PIC/S Annex 15 Qualification & Validation training course (online)

You will have access to the course for 12 months from the date of purchase.

A GMP training module Certificate of Completion is available for each successfully completed GMP education topic.

There are over 70 online cGMP training courses to choose from!

• You’ll gain access immediately upon completing your online purchase of the module.
• You can complete this course in multiple sittings or complete the training all at once.

• You can download, print and/or email your GMP/cGMP Certificate of Completion after successfully completing the Final Assessment of this online training course.
• Note: A GMP/cGMP Certificate of Completion is not a statement of competence but affirms you completed the online Qualification and Validation training course related to PIC/S Annex 15 guidelines.
• This training is for education purposes only and is designed to supplement your specific onsite training, induction training and direct Supervision for pharmacovigilance and other drug safety regulation compliance in your workplace.
• Once you complete this course, please continue to refer to the current regulations that apply to your specific region and specific product type(s)/marketing authorisations.