Quality from Start to Finish: “Do you know what you don’t know?”

Join us for an insightful discussion on ensuring quality every step of the way in your product or service journey. From inception to market, understanding Critical to Quality (CTQ) factors is paramount. We’ll delve into the intricacies of research and development, navigating GxP and IT regulations, and upholding data integrity throughout the process to empower informed decisions.

Key Learning Objectives:

• Keep Focus on the Dot on the Horizon: Stay aligned with your ultimate goal.
• Identify Essential Requirements: What are the essentials to reach your goal?
• Leverage Support Networks: Who can help you meet those requirements?
• Understanding Cohesion: Recognize the interconnectivity between your needs.

Guest Speakers:

Dorrine Bogers, BSc, studied analytical chemistry at the university of applied sciences of Eindhoven (NL). She joined Venn in 2002 implementing a Quality Management System based on Good Laboratory Practice, lead the Quality Assurance Unit and act as a GLP QA consultant. Before joining Venn, she held operational and management positions in several laboratories, both CRO’s as governmental, given her over 30 years of experience with quality systems. She has been involved in several QA projects as project leader or consultant in GLP, GCP and GMP projects for big pharma and small CRO’s including but not limited to, physical-chemical, toxicity, environmental, pathological, analytical, and clinical chemistry studies. Her experience includes performing GAP analysis and advising how to sculpture a quality system suitable for the business needs of the company and the regulatory requirements.

Erik Gout has over 35 years of experience in the pharmaceutical industry. He has been involved in numerous drug development projects as analytical scientist, pharmaceutical development scientist, Quality Insurance engineer and CMC project leader. His experiences also include Technology Transfers, writing, reviewing, and approving regulatory CMC documents, GMP QA audits and due diligence of various projects. He is currently a senior consultant Chemistry, Manufacturing & Control.

Hans de Raad is an experienced IT consultant whose strength is bridging the gap between business needs and IT capabilities, especially regarding security, privacy, and compliance. He ensures that IT infrastructure not only facilitates business processes but seamlessly integrates with organizational objectives without necessitating re-engineering. With about 20 years of experience in various sectors, including the life science industry, he is used to adhering to stringent compliance and validation protocols such as GxP, GAMP5, FDA Cfr 21 Part 11 and NEN7510. In addition, he is specialized in compliance auditing, GDPR/AVG policy implementation, ISO27001 auditing, and security best practices coaching. Hans is an active member of the RQA IT Committee and chairman of the DARQA IT Committee. As such he regularly attends discussion meetings and presents the latest insights during events. He is an expert in the intricate process of selecting and implementing electronic quality management systems and providing comprehensive implementation assistance. His methodology extends to crafting User Requirement Specifications and offering validation support. This includes planning, testing, and change management.

Martijn Doesborgh is an experienced QMP specialist with over 25 years of experience in several fields of the pharmaceutical industry. Initially starting as a chemical- and process development technician with process validation responsibilities, over the years he became a Quality Expert. He developed the linking pin position between manufacturing departments and QA, implementing key communication systems resulting in high levels of (cGMP) compliance and significantly reduced levels of misunderstanding. In 2011 he joined Yxion as a QA consultant. As the lead of the Quality Assurance section he has in the last 4 years empowered the transformation of Yxion into 3 major fields of expertise: Project Management & Enginering, Commissioning & Qualification & Validation and Quality Assurance. As a QA consultant he has led several Quality Sections of QA and manufacturing departments, implemented QA on the shopfloor, and prepared, hosted, participated in and followed up on many regulatory inspections (FDA, IGJ, ANVISA, JFDA etc.) and customer audits at manufacturing organizations.

Marijke Steenvoorde is an experienced GCP Quality Assurance Manager. She joined Venn in 2022 to lead the Quality Assurance department. Before joining Venn, she held positions in Quality Assurance as an owner and consultant of her own company and at Astellas, giving her 20 years of experience in clinical drug development in pharma and provider alike. She has been involved in numerous clinical drug development projects as a Global Quality Lead and as an Quality Assurance manager in multiple therapeutic areas, including, but not limited to, urology, dermatology, oncology, and gynecology from early discovery to marketing.  Her experiences also include implementation, improvement and maintenance of a Quality Management System and an audit database as well as management of an audit program and the organization, conduct, reporting and follow up of investigator site, vendor, and internal audits as well as the preparation, hosting and follow up of regulatory inspections and the identification of deviations and CAPA follow up. She’s a member of RQA and DARQA and has been chair of DARQA for the last 7 years.

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