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PHSS Annual Members Conference in association with UCL Q3P
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PHSS Annual Members Conference in association with UCL Q3P

Impact of changes in GMP regulations & ISO standard revisions.

When: 11/09/2015
Where: UCL School of Pharmacy
29 – 39 Brunswick Square
London WC1N 1AX
United Kingdom
Contact: Tamsin Marshall
+44 1793 824254

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This important PHSS – UCL Q3P conference considers the impact of GMP regulation changes, including Annex 1, 15, 16 and EU GMP (Orange guide) chapters 3, 5, 8 together with ISO 14644 – 1 and 2 revisions.

The industry and healthcare (pharmacies) involved in manufacture of both Sterile and non-sterile products that need to conform to GMP, are more challenged than ever in an environment with changing regulatory requirements based on science and risk.

The anticipated revision to Annex 1, manufacture of sterile medicinal products, is expected to be significant in impact on the industry so it is really important to follow and keep up to date with any changes.

Conversely regulations need to keep in-line with new product types, unique manufacturing challenges often requiring a balance between GMP and containment for contamination and cross contamination control, new technologies and complementary good manufacturing practice.

Following the opening key note presentation from Andrew Hopkins, MHRA Senior inspector and EMA Annex 1 working group, leader a discussion panel of society and association groups involved in recommendations for update will discuss key points considered for Annex 1 revision and the potential impact to the industry.

The discussion panel will include representatives from the PHSS, PDA, A3P, ISPE, R3 Nordic and ECA annex 1 working groups.
It is important to keep connected with these revisions and developments so this conference is not one to miss.

The Conference is free of charge to all PHSS members, non-members simply need to join the PHSS at a nominal fee providing access to the conference and many other membership advantages.

09:00 - 09:15
Welcome from PHSS Chairman and UCP Q3P Course Director
James Drinkwater and Khalid Sheikh

09:15 - 10:00
Revision of Annex 1 Manufacture of sterile medicinal products – a GMP inspector’s point of view.
Andrew Hopkins MHRA Senior Inspector

10:00 - 11:00
Panel Discussion – Annex 1 revision.
Discussion panel: MHRA, PHSS, A3P, PDA, ISPE, R3 Nordic and ECA.

11:00 - 11:45
Coffee and Viewing Exhibitions

11:45 - 12:30
Data Integrity:
Considering non-conformances, challenges, requirements and impact on product/ batch release.

Di Morris: GSK Global auditor,
Ex-MHRA senior inspector.

12:30 - 13:30
Lunch and Networking

13:30 - 14:15
Stream 1:
Changes and their impact in revisions of EU GMP Regulations: Orange Guide; chapters 3, 5, 8 and annex 15: Qualification and validation.
Malcolm Holmes: Consultant/ Freelance GMP/ PHSS regulatory update author.

13:30 - 14:15
Stream 2:
Annex 16: Certification of a Qualified person and batch release.
The impact of the revision and new requirements.


14:15 - 14:45
Coffee and Viewing Exhibitions

14:45 - 15:30
Stream 3:
ISO 14644 (part 1 & 2) revision update.
Key points about the revisions and potential impact on GMP qualification and operations.

Gordon Farquharson: GMP Consultant; Critical systems

14:45 - 15:30
Stream 4:
Impact of regulations in filling multiple products in the same facility, considering aseptic processing of non-hazardous product, cytotoxic products and biologically hazardous products, including live virus.

James Drinkwater: F Ziel Head of Aseptic processing technologies and GMP compliance.

Click here to download the programme

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