GMP - GLP - GCP
General context
The live courses are replaced by 8 webinars of 2h15min.
Are you interested to discover the manufacturing and regulatory environment in the Pharma R&D Industry? You want to know where investigational products come from, how they are made and what rules and regulations must be followed? In this course, you will get a detailed overview on Good Manufacturing Practice, Good Laboratory Practice and Good Clinical Practice.
After this training, you will:
- Understand the basics of Good Laboratory Practices (GLP) in a commercial R&D setting.
- Understand the context of the pharmaceutical industry and the quality rules required to manufacture a drug product.
- Understand the international regulation context (Good Manufacturing Practices, GMP)
- Be able to make the link GMP with the requirement of GCP (Good Clinical Practices) in a clinical research environment.
ECCRT aims for the best return on investment for the participant. Our goal is for trainees to leave the course with the capacity to use the information provided in the most practical way. Our expert trainers always encourage interactivity in the group. ECCRT supports the statement: “You tell me, and I forget. You teach me, and I remember. You involve me, and I learn”.
PhD students, postdocs and staff scientists working at VIB who want to learn about GMP, GLP and GCP.
- This training is free for VIB participants.
- The fee for non-VIB Academics is € 100 for both days (VAT incl).
- Note that upon no show without valid justification a fee of € 100 will be charged and you will be blacklisted for the VIB training program for 1 year. Click here for more information
Trainers
Hedwig Beernaert
Dr. Hedwig Beernaert is involved in many research projects using chromatographic and spectroscopic techniques. He is an author and co-author of more than 100 peer review publications.
Hedwig is chairman of a steering group Mutual Joint Visit program European Union (1994-1998). (8 reports), a member of the OECD steering group Mutual Joint Visit program (1998-2009) (10 reports).
He is an Invited lecturer in GLP matter on national and international meetings, an Organisator of different GLP training courses and performed more than 200 GLP inspections, both domestically and overseas.
Dr. Beernaert is also an Invited professor at the University of Leuven for lectures about the application of the OECD GLP Principles in test sites.
As Vice-chairman of the Belgian Accreditation Board BELAC he performed many assessments in laboratory according to the criteria of the ISO standard ISO 17025, ISO 17043 (Proficiency testing), ISO 15189 (clinical laboratories). More than 150 assessments and reports (1994-2013).
He is a GLP consultant and organisator of several GLP training courses at different domestically and overseas (China) organizations
Member of the Food Section of the Royal Flemish Chemical Society. Organistor of several symposia; Advisor of EuroFIR. Technical advices concerning the EuroFIR quality system framework; Certified reviewer of peer-review articles in internationals Journals.
Jolanda Muurman
Jolanda Muurman is Training and Development Manager at the Biotech Training Facility (Leiden). She has a BSc in Biotechnology and obtained a master degree in Management at the university of Greenwich. She has a broad experience in working in multi-disciplinary project structures in Drug Substance and Drug product development. Also, she has been involved in hosting inspections from clients and authorities frequently and have a broad experience in all facets of GMP. At the Biotech Training Facility, she is responsible for development and organization of GMP trainings in a fully equipped mock-up biotech facility.
Marleen Verbeeck
Marleen Verbeeck, is a trainer/coach and has been working at the European Centre for Clinical Research Training (ECCRT) since 2004.
She obtained her PhD in molecular biology at the University of Utrecht in 1990. After fundamental research positions at the universities of Utrecht, New York, Leuven and Maastricht, she changed her academic career in 1995. She gained solid grounding in clinical research, first as a clinical research associate, later as a medical writer combined with a position as trainer.
Marleen enjoys developing, lecturing, evaluating and developing comprehension tests of courses as well as boosting confidence and competence of clinical research professionals with different experience levels from the pharmaceutical, medical device industry and non-profit research organisations.
She has more than 15 years of educational expertise. She is author of scientific papers, clinical trial study protocols (phase I - IV) and clinical study reports. She has experience in medical areas such as : CNS, Gastroenterology, Gynaecology, Rheumathology, Cardiology, Oncology, Orthopaedics and Immonutherapy.
In addition, recently Marleen is also a regulatory consultant on European clinical trial legislation. Acquiring and conveying knowledge has always been her interest throughout her professional career.
Program
GMP & basic principles manufacturing process
22 June 2020
- Introduction in GMP (lecture)
- GMP, a brief introduction, regulations and guidelines
- The GLP, GCP and GMP landscape
- The world according to pharma
- How to implement? Insight, execution/performance and behavior, documentation
- GMP - assurance and principles, part I, II, III
- GMP - how do they do it?
- Pharmaceutical supply chain
- Basic principles of a (bio)pharmaceutical manufacturing process (lecture)
- Reference to the guidelines
- Biotech product characteristics
- API/bulk drug substance manufacturing and critical quality attributes (CQA’s)
- Drug product manufacturing and critical quality attributes (CQA’s)
- General manufacturing requirements
- Back-up: cell line management and impurities
Quality systems & working at a manufacturing plant
23 June 2020
- The main quality systems (lecture)
- Deviations
- CAPA
- Change control
- Investigating a deviation (workshop)
- Cases for investigation:
- equipment breakdown in grade A
- Filter test failure in an aseptic manufacturing process
- too much antifoam added during cell culturing
- Cases for investigation:
- Working in a pharmaceutical plant - departmental responsibilities
- Producing at Manufacturing Department
- Maintenance by the Facilities Department
- Testing at the QC Department
- The tasks of the QA Department and the role of the QP
- The Regulatory Affairs Department
Drug Development and Clinical Trials
24 June 2020
- Drug Development in Steps:
- Investigational Medicinal Products
- Non-Clinical Research
- Clinical Research in Steps: Different Trial Types, Timeline & Cost
- Rules for Clinical Research:
- Why Rules? Declaration of Helsinki and GCP
- Legislative Binding Rules for Clinical Research
- Linking GMP, GCP, GDP
- Investigational and Auxiliary Medicinal Products
Clinical Trials: Stakeholders, Principles, Documents, Cycle
25 June 2020
- Stakeholders of Clinical Trials
- Sponsor, Investigator, Ethics Committee, Regulatory Authority
- Principles and Documents of Clinical Trials
- Clinical Trial Principles
- Life Cycle of Clinical Trials
- Trial Design, Trial Approval / Authorisation, Selection of Investigators & Study Subjects, Collecting Data, Trial Results, Milestones
Responsibilities
30 June 2020
- Sponsor’s Responsibilities in Clinical Trials
- GCP – GMP – GDP responsibilities
- Investigator’s Responsibilities in Clinical Trials
- Investigational Products’ Documents
Quality assurance and positions in clinical research
1 July 2020
- Quality Assurance & Audit/Inspection Findings
- Quality Assurance & difference between audits & inspections?
- Is it a serious? Common findings & how to avoid them
- Difference between Regular Medical Care & Clinical Trials
- Sponsor’s Positions in Clinical Research in Clinical operations, Data management, Regulatory Departments, etc.
History & principles of GLP in Clinical Research
10 December 2020
- Major Principles of GLP
- GLP in Research & Development
History and Principles of GLP
10 December 2020
- GLP Documentation
- GLP today