Towards a new Quality Culture
25 years anniversary seminar “Towards a new Quality Culture”
With this theme we aim to inform the Seminar participants about global developments to reliably supply patients with affordable and good quality medicine. The rate of product lots accepted for release to the market in pharma is low when compared to other industries. The number of incidents of, sometimes life-saving, medicine not being available to the patient is increasing. This despite the large costs and effort of pharmaceutical companies to assurance of product quality. ISPE-NL has found several speakers to present to you developments and approaches that aim to improve performance indicating a trend towards a new quality culture.
- Main program and Young Professionals program
- Time reserved for networking with drinks and food
- Cost ISPE members € 90 ( non members € 180; Young Professionals € 65; members NIA, VCCN, NVZA € 135)
- Optional diner (€ 30)
Download our event flyer here
|13.30 -13.45||Welcome||René Nanninga (Chair ISPE Netherlands Affiliate)|
|13.45 -14.15||ISPE’s answer to trends in Pharma||Thomas Zimmer (VP European Operations of ISPE)|
|Prior to joining ISPE, Dr. Thomas Zimmer (Pharmacist) was Senior Vice President at Boehringer Ingelheim. In his 32 years with the company, he gained experience in development, production, quality and supply chain operations. Since 2013 Thomas is VP European Operations of ISPE.||ISPE in Europe, representing 4600 members out of nearly 20 000 members, plays a very important role in the new ISPE global strategy. Thomas Zimmer, will outline the main elements of this European strategy: what are the main topics, what is the content impacting the future of pharmaceutical production? How can companies prepare themselves? What is the role of the engineering function in this context? One major element are our European Conferences, now being established since 2014; a platform for all stakeholders in the pharmaceutical operations value chain. A Q&A session will follow the key note of Thomas. Please prepare your questions!|
|14.15 -15.00||Lean en Quality||Hans van der Zalm (QA manager DSM Sinochem)|
|Hans van der Zalm started working at Gist Brocades as laboratory technician in 1983. In this company, being amongst the first to isolate penicillin during WWII and ever since operating processes for penicillins and cephalosporins, his interest in GMPs as well as in quality controls and systems was aroused.
During his over 32 years career, he held a variety of Quality related functions like Quality Assurance Advisor, and - after takeover by DSM - Corporate GMP auditor and QA manager in multiple international manufacturing projects. Nowadays he is Quality Manager with DSM Sinochem Pharmaceuticals.
|Hans will give an inspiring example on how lean concepts have aided much in establishing an effective quality organization. His slogan is “know your own process”, which relates to both manufacturing and analytical processes. Not only ‘content’ wise but also in terms of information and work flows. He’ll guide us on applying simple approaches and from the “what” to the “how” in order to gain sufficient confidence in establishing “the
appropriate level of control”. Also he’ll touch upon behavior regarding compliance, continuous improvement and leadership on “first time right”. Hans will endeavor to demonstrate that achieving a compliance culture includes adopting the latter as a second nature, if not a habit, by all persons working in a pharmaceutical manufacturing organization, in other words: Having this “in the blood and in the brain”.
|15.30-17.00||Parallel session||See Young Professionals program|
|15.30-16.15||Drug Shortages||Bryan Wright (ISPE regulatory Affairs advisor)|
|Bryan Wright, former Group Leader of the MHRA Inspectorate, performing inspections for the GMP, GDP, GCP, GPvP, and the GLP Monitoring Authority Inspectorates. Now ISPE EU Regulatory Affairs advisor. Participated in the development and writing of the ISPE Drug Shortages Survey, the Drug Shortage Prevention Plan and the ISPE Drug Shortage Gap Assessment Tool.||Drug shortages (drugs not being available to the patient) is an increasing problem worldwide. Studies have pointed out that quality problems (e.g., contamination, presence of foreign particles) are the most common cause of drug shortages. Bryan will present the main conclusions of ISPE’s Drug Shortages Survey and ISPE’s drug shortages Prevention plan, as well as presenting the ISPE Drug Shortage Gap Assessment Tool, to help manufacturers identify potential quality risk areas.|
|16.15-17.00||Building more robust products and processes||Paul Rutten (Principal McKinsey Amsterdam)|
|Paul Rutten is a Principal in McKinsey's Amsterdam office since 1998. He leads the global Quality, Compliance and Remediation Service Line and is one of the leaders of McKinsey's Global Pharmaceutical and Medical Products Operations practice. He is the sponsor of McKinsey's benchmarking initiative POBOS, and is leading the collaboration of McKinsey with ISPE on Quality Metrics. He is the lead author of the book “Flawless - from measuring failure to building quality robustness in pharma”.||In the ISPE NL workshop, Paul will highlight that having zero errors should be the one overriding objective for quality in the pharmaceutical industry. He will highlight how companies can shift their emphasis from “eternal vigilance” to “production system design,” building more robust products and processes, and aiming for performance that comes as close as possible to “flawless.” Paul has ample experience about the perceived trade-off between fulfilling GMP compliance and lean production - and will share the insights based on POBOS and the Quality metrics work. Paul is planning an interactive session - so come prepared with your most difficult questions!|
Young Professionals Program
The International Society for Pharmaceutical Engineering - Affiliate for the Netherlands (ISPE-NL) is opening up for a new generation of pharmaceutical engineers by founding a Dutch ISPE Young Professionals network. The Young Professional (YP) is someone who is within the first four years of his or her career and who wants to develop his/her skills and network. The ISPE YP workgroup within the ISPE-NL aims to help the YPs in this, by organizing meetings and workshops that will focus on developing competences (e.g. project management or technical writing). Also planned for are introductions including Q&A sessions with prominent representatives or experts from Dutch pharma or associated organizations.
The ISPE-NL would like to use her 25th anniversary event to kick-off the Young Professional network in the Netherlands. The idea is to start with a joint program with the ISPE seniors followed by a YP specific program and a network dinner. Our objective is to demonstrate that ISPE-NL has added benefit to offer to the pharmaceutical Young Professionals in our country. The YP program will start with a speaker who will elaborate on his own career within the pharmaceutical industry and discuss his own experiences concerning career development. In the second presentation we will focus on competences interesting for YPs (for example project management) and provide suggestions which YPs may or can directly apply in their work.
|15.30-16.15||Lessons learned and insights in the opportunities of large pharma companies||Roderick van der Graaf (Business Unit Manager, Mentor Medical Systems)|
|Roderick van der Graaf will share his experiences in the Pharmaceutical Industry. Over the past 8 years he has held several positions in various departments with increasing responsibility. He would like to share his learnings and give an insight in the options Pharmaceutical Engineers have in a large pharmaceutical company.||Roderick’s current position is Business Unit manager at Mentor Medical Systems in Leiden, The Netherlands. Prior to this role he has held several positions within Janssen Biologics in Leiden. Starting as Shift Supervisor in 2007, he moved to the position of project leader for a global assignment at Janssen Pharmaceutica in Beerse, Belgium. After that he increased his leadership skills as Supervisor Facilities, Maintenance & Engineering, Manager Warehouse & Distribution Center and Sr. Manager Biotech Operations CoE. In April 2015 he moved from Janssen Biologics to Mentor Medical Systems, both part of the Johnson & Johnson family of companies.|
|16.15-17.00||Personal factors to become successful in industry||Emile van Corven (Principal Consultant, Xendo)|
|Emile van Corven will share his experiences in the Pharmaceutical Industry, including the transition that young biotech companies undergo when moving from an academic environment into a pharmaceutical /industrial environment. Over the past 23 years he has held several positions in process development departments with increasing responsibility. He would like to share his experiences about the various career possibilities for biochemists/engineers, and what are important personal factors to become successful in industry.||Emile’s current position is Principal Consultant at Xendo in Leiden, The Netherlands. Prior to this role he has held several positions within Pharming in Leiden, the Dutch Regulatory Authorities in Bilthoven, Crucell & Johnson & Johnson in Leiden. After a post-doc period of 5 years at the Netherlands Cancer Institute in Amsterdam, he started as scientist process development in 1992. He moved to senior scientist and project management functions, and was heavily involved in setting up GMP manufacturing facilities for human biopharmaceuticals. At Crucell/J&J he became director process development, heading the USP, DSP and pilot plant manufacturing groups at a global level. As such he was responsible for the process development and GMP manufacturing for various biopharmaceuticals (viral vaccines, mAbs) in the pipeline. In 2014 he moved into consultancy.|
|Event Date||14-10-2015 1:00 pm|
|Event End Date||14-10-2015 9:00 pm|
|Cut off date||12-10-2015|