Annex 15 – Qualification and Validation

Description

Online GMP Training topic: Regulatory compliance with PIC/s Annex 15 – Qualification and Validation.

Comply with PIC/S Annex 15 – Qualification and Validation

What does PIC/S Annex 15 cover?

• PIC/S Annex 15 covers regulatory compliance requirements (cGMP requirements) for the validation of GMP facilities, systems, and processes.
• This module is suitable for validation, engineering and quality personnel who work within GMP facilities.

This PIC/S Annex 15 (GMP training presentation) covers:

• Organisation and planning of validation activities
• The Validation Master Plan
• Validation Terms and Definitions
• Requirement for documented cleaning validation
• The basic V model for the validation life cycle

GMP Certificate Course for Annex 15 – Qualification & Validation

• This interactive e-Learning module provides the participant with an understanding of the GMP regulations relating to validation and qualification.
• After the successful completion of this online GMP training course, learners can save and print a personalised GMP Training Course Certificate (the GMP training certificate meets regulatory GMP requirements and should be kept in each attendees personnel training record file).

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. If purchasing more than one course, consider the training bundle options (GMP training program packages).

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 into 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 64 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.