Annex 15 – Qualification and Validation
Course duration: Allow 1 to 1.5 hours to complete this course.
Course duration: Allow 1 to 1.5 hours to complete this course.
Course duration: Allow 1.5 to 2 hours to complete this course.
Course duration: Allow 4 to 5 hours to complete this course.
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…
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….
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).
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…
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…
Course duration: Allow 10 hours to 15 hours to complete all 8 courses in this training bundle.
Course duration: Allow from 8 to 12 hours to complete all 6 courses in this online Validation training bundle.*
Top 10 Interview Questions in the Pharmaceutical Industry.
What are the “Top 10 GMP Certificate Courses” you need to complete in 2023 if you’re one of the following life science industry professionals? Top 10 GMP Courses You’ll Need This Year Here are the ‘Top 10 GMP Courses’ (GxP & GMP education topics) recommended for you to complete in 2023 to stay on track…
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