CONNECTING PHARMACEUTICAL KNOWLEDGE

Quality - Umbrella of Pharma

Quality - Umbrella of Pharma

ISPE NL Emerging Leaders community organises an event in Leiden Bio Science Park for undergraduates, recent graduates, students, young professional and emerging leaders with less than 5 years of experience in the pharmaceutical industry.

The aim of the event is to elaborate on the importance of the roles in demand within pharma: Quality Assurance (QA), Quality Engineering (QE), Quality Control (QC), Qualified Person (QP), and Responsible Person (RP). How can you educate yourself on these roles to begin with or to develop your career? QA officer: a police or an advisor? What does it mean to be compliant and which regulations are applicable? This knowledge will help participants to gain the right skills towards becoming successful QA, QE, QC, RP or QP professionals.

Event Properties

Event Date 19-Jun-2024 14.30
Capacity 45
Registered 40
Individual Price €10.00
Location Plus Ultra Leiden

Agendas

14:30 - 15:00

Welcome coffee & tea

15:00 - 15:15

ISPE Introduction

15:15 - 15:30

Quality Assurance (Geert-Jan Brouwers, Yxion)

15:35 - 15:50

Quality Control (Lineke Pelleboer, Bilthoven Biologicals)

15:55 - 16:10

Quality Engineering (Vanessa Pieters, VPieters Life Science Partner)

16:15 - 16:35

Coffee break

16:35 - 16:50

Qualified Person (Wilma Meijs, WMFA)

16:55 - 17:10

Responsible Person (Renando Goormachtigh, Yxion)

17:15 - 17:30

Q&A and closing remarks

17:30 - 19:00

Networking Drinks

Speakers

Wilma Meijs

Director of Wilma Meijs Farmaceutisch Advies BV

After obtaining her MSc in Biochemistry in 1990 and her PhD in Medicines 1996, Wilma Meijs started working in QC and QA departments in the pharmaceutical industry. Since 2008 she became QP. She has been working for companies producing small molecules and companies producing biotechnology products. Wilma will paint a picture of the regulations describing the responsibilities and duties of a QP. Furthermore, using some case studies, she will explain the daily decisions to be taken by a QP.

Geert-Jan Brouwers

Consultant QA Specialist at Yxion

After finishing his Secondary vocational education (M.L.O.), Medical Microbiology in 1992, and post M.L.O. course in 1993, he started working in QC, production, QA systems within the veterinarian pharmaceutical industry up to 2012. Thereafter he fulfilled numerous roles as QA Specialist consultant within Pharma, Food, and medical devices. Geert-Jan will paint a picture of the diversity of the role and requirements of a QA specialist within the organization, and the importance of a good cooperation with a QP/RP.

Renando Goormachtigh

Senior QA Consultant at Yxion

After graduating his Biochemistry (BSc.) study in 1988, he started in R&D and QC departments in the pharmaceutical industry. After about 10 years he switched to QA roles within GxP at different pharmaceutical and chemical companies. Since 2012 he specialized on GDP after in-depth training at ECA and co-ordinated vaccines storage and distribution, food supplements and was RP at a large Logistic Service Provider for pharmaceuticals. His presentation will contain the highlights of the role and duties of the RP within a pharmaceutical company or logistic service provider for medicines in relation to the GDP guideline, and his own experiences in practice.

Lineke Pelleboer

Director of Quality Control at Bilthoven Biologicals

Lineke Pelleboer is Director of Quality Control (interim) at Bilthoven Biologicals. She has an educational background, including a Bachelor of Applied Science in Biology and Medical Laboratory Research from Hanzehogeschool, Groningen, and studies in Food Technology. To date, she has over 15 years of experience across Research, Quality Control, Manufacturing, and Engineering, having worked in more than 20 pharmaceutical companies. Her experience allows her to navigate the challenges that arise in these fields, streamlining processes and improving organizational efficiency. At this moment Lineke is chair of ISPE NL. In her presentation at the ISPE NL Emerging Leaders half-day event, Lineke will highlight the essential role of Quality Control within the pharmaceutical landscape. She will discuss the skills needed to work in a Quality Control department, including technical expertise, attention to detail, problem-solving abilities, and effective communication.

Vanessa Pieters

Senior Consultant of VPieters Life Science Partner

Vanessa is a Senior Consultant at VPieters Life Science Partner and currently serves as Interim QC Manager for a Bio-assay department. With a background in Biotechnology, specialising in Bioprocess Technology, and over 25 years in the pharmaceutical industry, she brings extensive expertise in quality engineering. Her diverse experiences span R&D, downstream processing, QA, and QC operations which includes operational view, project management and management. Vanessa will share insights into the fundamentals of quality engineering and its role in projects involving building, construction, and equipment.

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