For Australian and New Zealand Manufacturers PIC/S Version 13 is due this year, aside from significant changes in Part 1, there are also significant changes in Annex 11, Computers Systems and Annex 15, Qualification and Validation. We plan to help you get ready now for the pending change.
Following on from the highly successful PIC/S Version 13 training PharmOut offered around the country to over 300 participants, we would like to make you aware of two new updated courses:
Computerised Systems Validation Training Course – Annex 11
Regulatory expectations and oversight on Computer Systems have changed radically with PIC/S, UK MHRA, US FDA, as well as the WHO all issuing Data Integrity Guidances. For example the 21 CFR Part 11 does not mention risk at all, hard to believe, obviously the subsequent guidance(s) do.
Thankfully there are tried and tested methodologies like the waterfall and V models and as well as GAMP®5 and IEEE / IEC 62304.
To help get you ready, we are offering a one day computerised systems validation training course covers the essential principles on how to use a risk-based approach in Computerised Systems Validation (CSV) but first, we need to know which systems are GxP and then the GxP critical touch points.
This course offers a high-level compliance review of the ever-changing GMP requirements, i.e. new PIC/S Version 13, Annex 11, and the US FDA and EU Data Integrity guidances to list some.
It is designed for busy professionals seeking training in a practical and cost-effective validation approach in the pharmaceutical, medical device, and veterinary industries.
By following a practical 3 step approach the course will help your compliance,
- Understanding the predicate rules, i.e. the GMP requirements,
- Embracing a risk-based approach,
- Then with establishing an excellent understanding of various CSV methodologies including those in the ISPE Good Automated Manufacturing Practice (GAMP®5) guidance, the waterfall, IEC 62304, EU & PIC/S PE 009 version 13, Annex 11 and the US FDA CFR Part 11 Electronic Records: Electronic Systems.
Included in the course is a practical 5-minute session on how to validate Spreadsheets, an essential tool in the modern pharmaceutical professionals armoury, a kind of everything you ever wanted to know, but were too afraid to ask.
Process Validation Training Course – Annex 15
This one-day Process Validation Training Course is designed to cover all the requirements of PIC/S version 13, Annex 15 and will also provide an overview of the latest concepts and guidance documents for Process Validation (including 2011 FDA guidance and 2015 EU guidance) as issued by the EU in 2015 and the US FDA Process validation issued in 2011. The course will provide practical insights into how “modern process validation” is carried out and how to avoid common and costly mistakes.
The US FDA and EMA have different approaches to Process Validation, understanding these approaches will provide your team with the best opportunity to develop and implement your own compliant process validation approaches, and of course manufacture and deliver safe products.
Upon completion of this Process Validation Training Course participants will;
- Understand how to set a risk-based process validation strategy and build into your documentation validation efficiency
- Clearly understand the expectations and how to comply with the US FDA three stage approach to Process Validation
- Clearly understand the expectations and how to comply with the PIC/S and EU approach to Process Validation, i.e. Annex 15 Qualification and Validation
- Understand the concepts of Continued Process Verification and Continuous Process Validation
- Understand how to establish and implement control strategies to maintain the validated state.
This highly popular one-day PIC/S Part 1 – Training Course is designed to highlight the pending changes between version 8 and version 13, provides a gap analysis tracking tool and many other practical GMP tips.
Want even more?
On the 24th and 25th July 2017 PharmOut will be hosting our 7th National Validation Forum, with a stellar cast of GMP rock stars and some engineers.
This remains the only annual event exclusively focused on supporting Australian Engineers and Architects on the design and construction of facilities, of course, there is a GMP and Validation track too.
This year we will follow this with 3, two-day Master Classes covering Validation, Computer Systems, and Sterile Manufacturing, that is Annex 15, 11 and 1.