GMP - GLP - GCP
General context
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 course is not open for non-VIB participants.
- 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
Program
GCP (Good Clinical Practice)
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 Good Clinical Practice Guideline
- Legislative Binding Rules for Clinical Research
Linking GMP, GCP, GDP
- Investigational and Auxiliary Medicinal Products
Stakeholders of Clinical Trials
- Sponsor, Investigator, Ethics Committee, Regulatory Authority
Principles and Documents of Clinical Trials
- Clinical Trial Principles “Which is the correct missing word?”
Life Cycle of Clinical Trials
- Trial Design, Trial Approval / Authorisation, Selection of Investigators & Study Subjects, Collecting Data, Trial Results, Milestones
Lunch
Sponsor’s Responsibilities in Clinical Trials
- GCP – GMP – GDP responsibilities
Investigator’s Responsibilities in Clinical Trials
Investigational Products’ Documents
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.
Course Closure
GLP (Good Laboratory Practice)
- Historical Perspective of GLP
- Major Principles
- GLP in Research & Development
- GLP Documentation
- GLP Today
Lunch
GMP (Good Manufacturing Practice)
Introduction: Expectations of course participants
Introduction in GMP (lecture)
- GMP, a brief introduction
- The GLP, GCP, GMP landscape
- The world according to pharma
How to implement?
- Insight, execution/performance and behavior
- GMP – Assurance and principles
- 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) o General Manufacturing requirements
- Back up: cell line management and impurities
- Part II: GMP for Active Product Ingredients
- Part III: Additional Documents
The main quality systems (lecture)
- Deviations & OOS
- 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 anti-foam added during cell culturing
Working in a pharmaceutical plant - departmental responsibilities
- Producing at manufacturing department
- Maintenance by the Facilities department
- Testing at the QC department
- Tasks of the QA department and the role of the QP
- The Regulatory Affairs department
Practical info
26 September 2022 - 27 September 2022
Leuven - Park Inn by Radisson
Martelarenlaan 36
3010 Leuven
Belgium
26 September 2022 - 27 September 2022
Leuven - Park Inn by Radisson
The hotel is located 300m from Leuven Central Station, just a short 5 minute walk.
26 September 2022 - 27 September 2022
Leuven - Park Inn by Radisson
Using your bike for longer distances? Check Cycle Highways.
26 September 2022 - 27 September 2022
Leuven - Park Inn by Radisson
Underground P1-Parking Station Leuven, Martelarenlaan 4, 3010 Leuven or parking De Bond, Martelarenlaan 18, 3010 Leuven.
26 September 2022 - 27 September 2022
Leuven - Park Inn by Radisson
+32 16 61 66 02
sales.leuven@parkinn.com