Annex 15 – Qualification and Validation
Course duration: Allow 1.5 to 2 hours to complete this course.
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EU Annex 21: Importation of Medicinal Products
Course duration: Allow 1.5 to 2 hours to complete this course.
Annex 2A ATMP Manufacturing
Course duration: Allow 4 to 5 hours to complete this course.
PIC/s Annex 2A for ATMPs – GMP Regulation Updates
This article provides an introduction to the PIC/S Annex 2A updates in Version 15 in relation to Good Manufacturing Practice (GMP) requirements for Advanced Therapy Medical Products (ATMPs). PIC/s guidance on ATMPs and biological medicines: what changed in PIC/S Version 15? GMP requirements for the production of ATMPs (in Annex 2A) are now in a…
PIC/S Annex 2B Biological Products for Human Use
GMP regulations (PIC/S guidelines) for Biologicals manufacturing were covered in the PE009-14 PIC/s (Annex 2: Manufacture of Biological Products for Human Use). However, PIC/S Annex 2 was changed in PIC/s Version 15 (now Version 16). The original PIC/S Annex 2 was divided into 2 separate Annexes, Annex 2A (ATMPs) and Annex 2B, covering Biological products….
Annex 2B – Manufacture of Biological Substances & Medicinal Products for Human Use
Course duration: Allow 1.5 to 2 hours to complete this training course.
Note: This course currently covers GMP requirements in PIC/S Annex 2B which are applicable to the manufacture of biological substances and medicines as per PIC/S publications PE 009-15 & PE 009-16 (2022).
Validation Training
Validation Training for Life Sciences & Pharmaceutical Industry Professionals Personnel involved in qualification, validation & verification activities should be appropriately qualified, trained and experienced to fulfil their responsibilities. In this article, we’ll review online Qualification & Validation Training Courses including Certificate GMP courses from onlinegmptraining.com, and Pharmaceutical Manufacturing Fundamentals training, which is suitable for validation…
GMP eLearning – Top 5 Induction Programs
What are the Top 5 GMP eLearning induction programs in the life sciences industry? If you manage Induction Programs for your new employees, it’s likely you need to get them up to speed within a rapid time frame. It’s often difficult to devote uninterrupted time to training new employees. Finding Managers with time available to…
Changes to PIC/S GMP
What updates or changes to PIC/S GMP Guidance do you need to understand; and what is the latest version of PIC/S GMP Guidance and PIC/S Annexes?
GACP & GMP for Herbal Medicine Manufacturing
Introduction to compliance with GACP, GMP and Medicinal Cannabis Industry Regulations | Industry-specific courses (Medicinal Cannabis Industry Education Compliance Topics). PIC/S GMP Annex 07 for Herbal Medicine Manufacturing compliance requirements Are you needing to train your employees, contractors, warehouse personnel or suppliers in PIC/S GMP (Good Manufacturing Practice)? If your team needs to understand the…
Medicinal Cannabis Industry GMP Compliance (bundle)
Course duration: Allow 10 hours to 15 hours to complete all 8 courses in this training bundle.
Induction Validation
Course duration: Allow from 8 to 12 hours to complete all 6 courses in this online Validation training bundle.*
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