The ''Quality Management in Pharma and Biotech'' course, first organized in 1997, has successfully given hundreds of (aspiring) Qualified Persons and other quality professionals a solid basis to fulfill their essential role in the pharmaceutical industry and hospital pharmacies. Previously organized by PAO Farmacie, now by PCS Academy.
Quality Management in Pharma and Biotech (Module 1 to 4)
Four modules offering an integrated approach to quality management in pharma and biotech.
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Based on 2,089 participants
GMP & GDP training for pharma & biotech
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Language:
- 13 days in total
This training contains:
Training Dates
This course combines a number of modules that have fixed starting dates. The moment of registration determines which module or course you can attend first.
The modules included in this course are:
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Quality Management – The Role of the Qualified Person
This training provides insight into an integrated approach on quality management as a good business practice in the pharmaceutical...
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Quality Management in Drug Development
This training program is designed to equip professionals in the pharmaceutical industry and hospital pharmacies with the...
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Quality Management in Sterile Manufacturing
The sterility of a pharmaceutical product can only be assured when a series of control measures are in place. The sterility...
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Quality Management in Biopharmaceutical Manufacturing
Biopharmaceuticals are the next generation of medicines. As they originate from live cells, there are several quality concerns...
It is not required to follow the modules in sequential order.
Description
The Training
Target Audience
Professionals in pharmaceutical and biotechnological industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Postgraduate students.
The course is aimed at (young) professionals in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control, Quality Assurance, or Regulatory Affairs who are dealing with complex quality systems.
The target audience needs to gain an in-depth understanding of these systems to improve quality management in their own organization.
The course is an international training program in English and requires, at minimum, a Bachelor’s Degree level (HBO level in the Netherlands).
When there are no English-speaking participants, the course language will default to Dutch.
(University) Students
Results
After having followed all four modules, you will have:
- Basic qualifications for your Qualified Person (QP) status application after successful completion of all four exams, combined with a relevant university degree.
- Gained a clear overview of the essential quality systems required to improve quality management in your own organization.
- Thorough theoretical and practical knowledge on compliant QP product release, safeguarding the final quality of products administered to patients.
Contents
Course structure
Expert knowledge and real-life case studies are combined to form an ideal learning experience. Professionals from industry, academia and national regulatory authorities such as Dutch IGJ will share their wealth of experience and knowledge during the course.
The course is highly interactive. The program is offered as a combination of self-study, theory, and practical case studies.
All four modules
It may be that some modules have been fully booked, in that case, you may need to follow a module in the subsequent year. Contact PCS for more information.
Discount price when following all four modules: €8.550 (including 20% discount). All four exams can be taken for €1.400,00 and will be awarded a Certificate of Achievement for each Module if passed.
In the event of cancellation, we refer to the general terms of condition of PCS (www.pcs-nl.com).
All modules are organized in the area of Utrecht, The Netherlands.
Certificates & accreditation
You will receive a certificate of attendance after attending a module. Additionally, you are offered the possibility to achieve full completion of the modules through an examination. In combination with a university degree in, e.g. pharmacy, biology, chemistry or (bio)pharmaceutical sciences, and with relevant practical experience, successful completion of all modules of the training course forms a good starting point to apply for a Qualified Person (QP) status.
PCS will apply for accreditation for each individual module with hospital pharmacists’ professional association NVZA.
Program
| Lecture | ||
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| Module 1 - Quality Management – The Role of the Qualified Person | Day 1 | ||
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Introduction: The Roles and duties of the Qualified Person in Pharmaceutical Quality Management
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Roadmap to realize Sustainable Quality and Regulatory Compliance Performance (IGJ)
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Training, Qualifications and Roles & Responsibilities
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Change Control
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Deviation & CAPA Management
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Complaint handling to recall (QP involvement)
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| Module 1 - Quality Management – The Role of the Qualified Person | Day 2 | ||
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Validation & qualification
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QP Skills & Challenges
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Trending and Management review and QP involvement
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The QP Declaration
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API & Excipients
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Challenges of a QP in Industry
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QP role in Hospital environment
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Quality Control and the QP
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Out-of-Specification (OOS) including batch decision: release or reject situation
Casestudy
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| Lecture | ||
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| Module 1 - Quality Management – The Role of the Qualified Person | Day 3 | ||
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The Critical Impact of Culture and Behavior: Introduction
Casestudy
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Lessons from the Case Study Quality Culture & Behaviour
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Case Study Presentation and Discussion: Risk Management (as per ICH Q9)
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Case Study Presentation and Discussion: Deviation Management
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Current regulatory development and inspection highlights (IGJ)
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Questions & Answers and Discussion
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| Lecture | ||
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| Module 1 - Quality Management – The Role of the Qualified Person | Day 4 | ||
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Case Study Presentation and Discussion: Third Party Operations
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Case Study Presentation and Discussion: Data Integrity
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MAH responsibilities
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The registration dossier - its development and life-cycle
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The QP and the registration dossier
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Critical points in scaling up (process from development to clinical to commercial)
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From R&D lead to development active substance to pharmaceutical formulation
Introduction to Quality by Design and Risk Management
Casestudy
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| Lecture | ||
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| Module 1 - Quality Management – The Role of the Qualified Person | Day 5 | ||
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Toxicology & HBEL's
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GLP basics
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Safety and Pharmacovigilance
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Investigational Medicinal Products and the QP
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Workshop
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End of the training, closing remarks
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| Lecture | ||
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| Module 2 - Quality Management in Drug Development | Day 6 | ||
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Welcome, Introduction and Personal Expectations
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Introduction to Drug Discovery - From Patient to Target Product Profile (TPP)
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Pharmacokinetics and pharmacodynamics (PK/PD)
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The IMPD and the Registration Dossier
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Getting to know the IMPD and the Registration Dossier - Where to find what information
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Product Development for the Purpose of Non-Clinical and Clinical Studies
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Product Development (TPP, CPP & CQA)
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Analytical Development
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Product & Analytical Development
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| Lecture | ||
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| Module 2 - Quality Management in Drug Development | Day 7 | ||
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Opening and Reflection
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Introduction GLP & Non-Clinical Studies
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Non-Clinical Studies
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Introduction GCP & Clinical Studies
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GCP & Clinical Studies
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Theory of GMP for IMP’s and its practical aspects including the role of the QP for IMP
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From development documentation to IMPD to registration filing
Changes
Deviations and their impact on the regulatory dossier
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Reflection and closure
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| Lecture | ||
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| Module 3 - Quality Management in Sterile Manufacturing | Day 8 | ||
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Welcome and outline of the course
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Biology of microorganisms
Implications for pharmaceutical production and quality control
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Sterile manufacturing: a philosophy on design and control
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Environmental monitoring
Case study
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Pharmaceutical water systems and utilities
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The gowning procedure
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| Module 3 - Quality Management in Sterile Manufacturing | Day 9 | ||
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Sterilization methods: steam, dry heat
Exercises for steam
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Cleaning and desinfection
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Sterilization methods: Filtration and alternative methods
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Case studies: Sterility Assurance in practice
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Contamination Control Strategy
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| Module 3 - Quality Management in Sterile Manufacturing | Day 10 | ||
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Validation of aseptic processes
Case studies
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Aseptic operations in ATMP manufacture
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Workshop: the role of the QP in assuring the quality of sterile pharmaceuticals
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Evaluation of the course
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| Lecture | ||
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| Module 4 - Quality Management in Biopharmaceutical Manufacturing | Day 11 | ||
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Cell line development and cell bank preparation
Theory and case study
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Upstream process development for biopharmaceutical products
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Purification survey of unit operations and process integration
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Welcome and introduction
Opening workshop
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Introduction to biotechnology:
Applications and elements of the biotechnological production process; quality and regulatory aspects
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| Lecture | ||
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| Module 4 - Quality Management in Biopharmaceutical Manufacturing | Day 12 | ||
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Development, tech transfer and commercial production of monoclonal antibodies by cell culture – Part 2
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Development, tech transfer and commercial production of monoclonal antibodies by cell culture – Part 1
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Design of an industrial process for purification of biologicals
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Protein analytics of biopharmaceuticals: relevant assays and their principles
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| Module 4 - Quality Management in Biopharmaceutical Manufacturing | Day 13 | ||
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Critical attributes and comparability studies
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Quality challenges for Advanced Therapy Medicinal Products (ATMPs)
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Immunogenicity and formulation of biopharmaceuticals
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Pathogen safety
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Biosimilars: a new class of licensed biotech products
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Closing Workshop
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Evaluation of the course
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Practical Information
- Difficulty / Level:
- Languages throughout the modules:
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English spoken language (primary)
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Dutch spoken language (secondary)
- Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
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- Learning form:
- Classroom
- Requires preparation:
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Yes.
Every module in this series contains homework.
- Includes exam:
- Yes.
- Exam price:
- €1,400.00 ex. VAT per participant.
