Monday, 12th March 2012, 1.30 pm, Rochestown Park Hotel, Cork
The Ireland Section of the ISA have organised a seminar on PAT/QbD with a tie into to the new guidance on Process Validation. It is scheduled for 13.30 Monday 12 March 2012 at the Rochestown Park Hotel in Cork.
The seminar is aimed at Process and Automation engineers, Quality Assurance and Process Development people. The seminar is a half day event.
After the preliminary introductions Gert Mølgaard— NNE Pharmaplan will address
“FDA’s new Process Validation: Continued Process Verification in a PAT
Gert Moelgaard is Vice President for Strategic Development in NNE Pharmaplan. He has been working in the pharmaceutical industry since 1982 and has experience in a number of major engineering, automation and validation projects within pharmaceutical manufacturing.
He has made contributions in international conferences on automation, GAMP (Good Automated Manufacturing Practice), process validation, PAT, manufacturing excellence and Quality by Design.
He has contributed to several books and technical guidelines. He is a past chairman of ISPE (International Society for Pharmaceutical Engineering) and has been very closely involved in ISPE’s cooperation with industry and regulators, especially on the PAT initiative and other related science- and risk based activities within the new Quality by Design paradigm of pharmaceutical manufacturing.
He is currently involved in the training of FDA’s field investigators on the new FDA Guideline on process validation from 2011.
Next Prof. Brian Glennon — University College Dublin, will discuss “Novel PAT methods for Process Design and Optimisation”
Professor Glennon is from the UCD School of Chemical and Bioprocess Engineering and is currently Deputy Director of the Solid State Pharmaceutical Cluster, and SFI-funded collaboration between academic institutions in Ireland and 8 major pharmaceutical companies. He is also Principal Investigator on the Enterprise Ireland funded Industry-Led Research Programme on “Bioprocess Applications of Process Analytical Technology”.
He is co-founder of APC Ltd, which delivers specialist process engineering solutions to the international pharmaceutical industry for the efficient design and optimisation of pharmaceutical processes.
Brian Nolan, MSD will talk on “The Challenges of turning a PAT Concept into a reliable Process Control System.”
Brian Nolan is the Automation Manager at MSD in Swords, Dublin (previously Organon) for the last 12 years. MSD in Swords manufactures and packages hormonal tablets, creams, sterile injectibiles and medical devices. MSD in Swords have recently been audited by the FDA for the approval of a new drug product developed using PAT and Quality by Design concepts.
Brian qualified as an Electrical/Electronic Engineer in 1988 from Dublin Institute of Technology.
Prior to joining MSD Swords Brian worked in Glanbia Food Ingredients, Ballyragget.
Brian is a member of the ISPE’s GAMP Special Interest Group on Validation of Process Control Systems and also the ISPE UK/Irl PAT Special Interest Group.
Dave Gibson, GlaxoSmithKline will conclude the seminar with a presentation “Innovation in Pharmaceutical Manufacturing—Next Generation Investments”
David Gibson is currently Head of the Innovation & Sustainability Centre of Excellence within the Global Manufacturing and Supply division of GlaxoSmithKline. This entrepreneurial group identifies business opportunities to implement innovative technologies, novel processes and new ways of working that will radically decrease manufacturing costs, drive sales growth and deliver greener products. Using “Open Innovation”, this group collaborates across industry and academia to identify innovative technologies or business models that can bring about this transformational change.
Previously David worked with Wyeth Pharmaceuticals (acquired by Pfizer) where he had roles of increasing seniority in Product Development and Manufacturing. This culminated in David defining and leading the initiative to integrate late stage development and manufacturing across the Wyeth pharmaceutical business.
The seminar will terminate with a question and answer session.
Places may be booked on the ISA Ireland website.