GAMP Forum
UK Meeting
3rd April 2014
3rd April 2014, Stevenage
Introduction
Central Engineering & Facilities Director
33 years Pharmaceutical and Medical Device experience in Engineering
International involvement in Industry initiatives primarily through the
ISPE include:
– Chair of GAMP UK
– Member of the ISPE GAMP Council and European Steering
– Permanent Member Technical Documents Committee
– Task team leader for ISPE Decommissioning Guide
Chaired group producing
Contributor and part of steering
Update
• Changes to the Steering Committee:
o Nichola Stevens and John Andrews have
joined the Steering Committee
o Please don’t feel shy to track down any
member of the Steering Committee
3rd April 2014, Stevenage
Thank you to......
• Our hosts for today’s Forum -
Special thanks to Heather Watson, GlaxoSmithKline
& Carl Stanbridge, Sodexo
for their efforts in making this possible
3rd April 2014, Stevenage
Welcome to Stevenage
• The history of Stevenage lies near the line of the
Roman road from St Albans to Baldock. Some Roman
remains were discovered during the building of the
New Town, and a hoard of 2,000 silver Roman coins
was discovered in 1986
• A little to the east of the Roman sites the first Saxon
camp was made in a clearing in the woods where the
church, manor house and the first village were later
built.
• In the Doomsday Book, the Lord of the Manor was
the Abbot of Westminster Abbey. The settlement had
moved down to the Great North Road and in 1281 it
was granted a Royal Charter to hold a weekly market
and annual fair (still held in the High Street).
• This area was the home of Sally Deard, who was the
last recorded witch to be burnt at the stake in England
in the 18th Century
3rd April 2014, Stevenage
Hosts of Future Meetings
Spring meetings in the South
Autumn meetings in the North
• Thank you to all our sponsors –
November 2014 - Waters, Wilmslow
April 2015
We are looking for a Sponsor from the South of England for the
Meeting around April time in 2015
3rd April 2014, Stevenage
House Keeping
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Facilities
Fire Alarms
Mobile phones
Refreshments
Questions
Contacts – GAMP Forum
3rd April 2014, Stevenage
Feedback
• Feedback form is
provided
• Very important that we
get feedback
• Your chance to be
heard
• Delegates to suggest
preferred topics on the
feedback forms TODAY
3rd April 2014, Stevenage
Round Table Sessions
• Sign up for today's round table (breakout)
sessions before end of lunch
• (1) Cloud include Cloud SIG update
Kathy Gniecko, GAMP Cloud SIG Lead, Hoffman-La Roche
& Thana Subramanian, Roche Products Ltd
• (2) Agile
Tony Hewer & Richard Meinesz, Medidata Solution WorldWide
& Steve Tinson, SciTech Engineering Ltd
• (3) Data Integrity
Roger Buchanan, Eli Lilly & Nichola Stevens, AstraZeneca
3rd April 2014, Stevenage
Agenda - Morning
09:00
Arrival and Refreshments
09:30
Chairman’s Welcome
Mark Foss, CooperVision
09:45
Sponsor’s Welcome
Heather Watson, GlaxoSmithKline & Carl Stanbridge, Sodexo
10:00
Case Study - Developing a Clinical Application using Agile Methodology
Tony Hewer, Medidata Solution WorldWide
10:45
Networking and Refreshments
11:15
Case Study - Spreadsheet Validation Ensuring Lab Data Integrity
Thana Subramanian, Roche Products Ltd
12:00
12:30
Regulatory Intelligence & Special Interest Group Update
Mark Foss, CooperVision and John Andrews, Integrity Solutions
Lunch and Networking
3rd April 2014, Stevenage
Agenda - Afternoon
12:30
Lunch and Networking
1:30
Round Table Sessions
(1) Cloud include Cloud SIG update - Kathy Gniecko, GAMP Cloud SIG Lead,
Hoffman-La Roche & Thana Subramanian, Roche Products Ltd
(2) Agile – Tony Hewer & Richard Meinesz, Medidata Solution WorldWide &
Steve Tinson, SciTech Engineering Ltd
(3) Data Integrity – Roger Buchanan, Eli Lilly & Nichola Stevens, AstraZeneca
2:30
Networking and Refreshments
3:00
Round Table Feedback & Discussion
3:30
Moving From Quality Control to Quality Assurance
Guy Wingate, GlaxoSmithKline
4:15
Q&A
4:30
Close
3rd April 2014, Stevenage