ISPE Professionals Testimonials

Home >> ISPE Community >> Volunteers >> ISPE Professionals Testimonials

Volunteers

Winnie Cappucci, Assoc Director IT Systems Compliance NA, Bayer HealthCare

Before GAMP computerized systems compliance was fragmented and undisciplined. Every organizational unit within every company was in effect defining their own approach to computerized systems compliance. Even within a company these definitions often

conflicted with or contradicted each other. This wasted a lot of a company’s time and money. It also created difficulties during regulatory inspections, and in our relationships with our suppliers because of this lack of consistency within the industry or from the consultants we worked with. GAMP changed this picture dramatically by bringing industry, suppliers, consultants and regulatory authorities together on an international level to develop a pragmatic approach to computerized systems compliance.

“When I moved into a global role in a multi-national company 15 years ago, one of my tasks was to work with an international team to develop a standardized approach to computerized systems compliance for the corporation. Several members of this team, including myself, were members of the international GAMP community. The fact that GAMP guidance was very practical and was developed internationally made it easy for the team to say that GAMP would be the foundation of our standardized approach. This allowed us to develop and gain approval our compliance program efficiently. It was also a huge selling point when we rolled this approach out within the company.

“These advantages are still true 15 years later. I have worked for a different multi-national company for the last 4 years and once again was part of a global team to develop a standardized approach to computerized systems compliance for the corporation. These same factors listed above caused the team to make GAMP the foundation of our program for computerized systems compliance.

“Additionally, working within the GAMP community has given me the opportunity partner with thought leaders from both industry and the regulatory authorities in the field of computerized systems compliance.”

A sample of positions held where GAMP played a critical part:

Quality and Compliance Specialist
Develop and implement Bayer's global standards for computer systems compliance.
Part of the core team that led the development of GAMP® 5, published in 2008.
GAMP America Steering Committee
GAMP Editorial Board
Chair of the GAMP Council
Co-Chair of the GAMP Outsourcing SIG.

Randy Perez, Executive Expert, IT Risk Management and Compliance, Novartis

“Since becoming involved in CSV in 1995 I have served with volunteer groups that were instrumental in defining the way computer validation was done, first with PhRMA, then after that group was eliminated briefly with PDA, and finally settling into GAMP when the Americas regional group was formed in 2000.

“Of these associations GAMP has far and away been both the most successful and the most rewarding. It has enabled me the opportunity to develop a powerful network of the top minds in the field, both in industry and regulatory agencies. It has afforded the opportunity to be a contributor to several GAMP publications, most recently GAMP 5. I like to think that I have been able to help to shape a process for regulatory compliance that over the years has become both leaner and more effective. That's a rare combination to achieve, and is one of which I feel justifiably proud.

“I would be remiss if I failed to mention the wonderful friendships that have developed with my GAMP colleagues. Although my many commitments to ISPE require a tremendous amount of work whenever I am at a conference, the opportunity to spend time with these friends is a highlight for me that is icing on the cake.”

Positions held where GAMP played a critical part:

For Novartis:

Senior Scientist in Chemical Development
Senior Scientist for Chemical Manufacturing Technical Support
Head of Computer Validation
Executive Expert IT Risk Management and compliance.

For ISPE:

GAMP Americas SC 2000-date
GAMP Council 2002-date
Chairman of GAMP Americas 2002-2007
International Board of Directors 2005-date
Secretary 2008
Treasurer 2009
Knowledge Mgt TT 2009

Guy Wingate, VP & Compliance Officer for Global Manufacturing and Supply, GlaxoSmithKline

“I joined ISPE back in the early 1990s when I was a junior engineer who had somehow got mixed up with a new thing called computer validation that no one seemed to know much about. At this time computer validation was a high profile regulatory issue but there was no consensus on a standard way to fulfil regulatory expectations. It was real headache especially if you were challenged to spend the minimum amount to guarantee regulatory inspection success. I can remember making a presentation on computer validation at an ISPE conference held in Stuttgart and being most impressed by the practical nature of ISPE members such as Tony Margetts - I knew straight away that I wanted to be a part of this organisation. Little could I have imaging then how involved I would become,…

“My first interactions with GAMP were as an industry reviewer when its first draft guidance for validating computer systems was launched back in 1994. It was an exciting time collaborating with regulators and members of other companies to define standard new ways of working. Two years later I founded with the support of the UK MHRA regulatory authority (Tony Trill) an organisation called the Supplier Forum to complement GAMP which ay that time was more focused on pharmaceutical manufacturers as members (the two organisations were merged into one about eight years ago). By this time I was a team manager in the engineering function of a major chemical manufacturer called ICI which had been spun off to create a separate company which is now part of ABB. A year later I was invited to join the GAMP Steering Committee by its then chair David Selby and the year after that I was hired by GlaxoWellcome to establish a new UK computer validation group to address some serious computer validation issues found by the FDA. Soon afterwards an Industry Board was created in GAMP to ensure we focused on key topics of biggest benefit to industry and I chaired this group. The management of a multi-site team, the strategic thinking for corporate policy and master planning complemented the leadership role I was now taking on with GAMP which included development of the fourth edition of GAMP Guide (GAMP4). The coming years were a time of great personal growth and satisfaction of what was achieved through team working.

“GAMP celebrated its 10^th birthday in 2001 and we had a big party to say thank you to all the contributors who had participated over the years. It was a great event and that same year with Paul D’Eramo and Randy Perez we launched GAMP Americas, re-badged the UK/European Steering Committee as GAMP Europe, and created a new governance group that we called GAMP Council. By now I was Director of Global Computer Validation at GlaxoSmithKline (GSK) with the merger of GlaxoWellcome and SmithKline Beecham. Subsequent years saw a tremendous growth in the GAMP organisation with new national affiliate groups being established – a growth that continues today – a numerous GAMP publications come to fruition. I led the development of GAMP5 and the Good Practice Guide on Electronic Records and Signatures. The latter was a real breakthrough following the ISPE White Paper I helped develop influence FDA expectations towards taking a risk-based approach. It is appropriate here to acknowledge some of the unsung GAMP heros who over the years have put in a huge amount of effort reviewing and editing documents to make them ready for publications (Sion Wyn, Colin Jones, Gail Evans, Chris Clark to name but a few).

“In terms of my personal career, I took the opportunity in 2005 to broaden my experience, which up to this point has been focused on computer compliance, and take on a role with the longest job title I have ever had looking after QA Technology Strategy, Quality Management Systems and Knowledge Management. A key achievement from my time in this role was taking the company Quality Management System (QMS) which covered all GMP operations to the next level of maturity, comprising a fundamental review and revision to implement new quality insights. My career was moving me away from GAMP but I continued to have a strong personal interest and I led the task team who developed the fifth edition of the GAMP Guide (GAMP5). Not long afterwards I took on the role of Site Quality Director for one of the largest and most complex manufacturing sites in the GSK network. No longer the theory of corporate quality, but living it on the front line of manufacturing. This too was a very busy period of my career with the introduction of the first biopharmaceutical product and vaccine to be manufactured at the site. At ISPE I broadened out too taking on co-chair role for new guidance being developed applying ICH Q9/ASTM E2500 to Commissioning and Qualification, and then being elected in 1998 to my great delight to become a member of the International Board of Directors.

“I am currently VP & Compliance Officer for Global Manufacturing and Supply at GSK. It is another big change with new challenges and development opportunities. I have handed over chairmanship of GAMP to Winnie Cappucci supported by Chris Reid and Kevin Martin who I know will lead it to even greater success. My career has been driven by wanting to make a difference, and ISPE has enabled me to meet new people with a similar outlook and work together on common goals. As I reflect back it is clear that I would not have been so fortunate in my career progression without the development opportunities I have found through ISPE membership. One thing I know for sure is that when my children ask me what I do at work I will have plenty to tell them about great people, friendships and the things we achieved together.”

A sample of positions held where GAMP played a critical part:

1992 – My first computer compliance presentation for ISPE at Stuttgart
1996 – Founding Chair of new Supplier Forum as sister group to GAMP Forum
1997 – Joined GAMP Steering Committee
1999 – Joined Glaxo Welcome and UK Computer Validation Manager
1999 – Chair of newly formed GAMP Industry Board
2000 – GAMP Europe established and GAMP Americas launched, Led task team producing GAMP4 Guide
2001 – GAMP celebrates 10 year anniversary (Head of MHRA in attendance with Bob Best), Appointed Director Global Computer Validation for newly merged GlaxoSmithKline, and first Chair of GAMP Council
2005 – Led task team producing ISPE Guidance on Electronic Record & Signatures, Appointed Quality Director for QA Technology Strategy and Quality Management System
2006 – Appointed Site Quality Director for major GSK steriles manufacturing site
2007 – Led task team producing GAMP5 Guide
2008 – Elected to ISPE International Board of Directors, co-chair of ISPE Task Team developing new guidance for applying ICH Q9/ASTM E2500 to Commissioning & Qualification
2010 – Appointed VP & Compliance Officer for Global Manufacturing & Supply at GSK

Sion Wyn, Owner, Conformity Ltd.

“GAMP has been absolutely central to my professional life for nearly two decades now. It is without a doubt the leading source of discussion, solutions, and guidance on computer system compliance and validation in life sciences. GAMP defines the topic area, and has been hugely effective in transforming practice for the better. The focus is – as it should be – on product quality and patient safety.

“GAMP COP members are a friendly and caring – and powerful - group of dedicated professionals who are really excited about sharing knowledge, experience, and best practices. They have a real dedication to solving real-world problems and to getting the job done. Pragmatic, professional and passionate are words that best sum up the GAMP COP.

“I’m grateful for the improved quality and extent of life that modern pharmaceutical has provided some of people dearest to me, and I’m very proud to belong to a community that is committed to encouraging innovation and technical advances in this field.”