Quality Management in Pharma and Biotech (Module 1 to 4)

Four modules oﬀering an integrated approach to quality management in pharma and biotech.

Based on 2,089 participants

GMP & GDP training for pharma & biotech

Language:
13 days in total

€ 8550 ex. VAT

This training contains:

Lunch

Course dinner

Digital copy of materials

Training certificate

Certificate of competence

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:

Module	Dates	Language	Can I attend this module this year?
Module 1 Quality Management – The Role of the Qualified Person	The next available edition starts in Apr 2025.	English spoken language (primary)	Follow in 2025.
Module 2 Quality Management in Drug Development	The next available edition starts in Jun 2025.	English spoken language (primary)	Follow in 2025.
Module 3 Quality Management in Sterile Manufacturing	The next available edition starts in Oct 2025.	English spoken language (primary)	Follow in 2025.
Module 4 Quality Management in Biopharmaceutical Manufacturing	The next available edition starts in Nov 2024.	English spoken language (primary)	Yes.

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...
Quality Management in Drug Development

This training program is designed to equip professionals in the pharmaceutical industry and hospital pharmacies with the...
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...
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

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.

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.

If you're a pharmacist or hospital pharmacist interested in earning accreditation points by attending this training,

(University) Students

Master- and PhD-students get a discount of 25% per module/training.

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.

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	Module	Day
Module 1 - Quality Management – The Role of the Qualified Person \| Day 1
Introduction: The Roles and duties of the Qualified Person in Pharmaceutical Quality Management	Module 1	Day 1
Roadmap to realize Sustainable Quality and Regulatory Compliance Performance (IGJ)	Module 1	Day 1
Training, Qualifications and Roles & Responsibilities	Module 1	Day 1
Change Control	Module 1	Day 1
Deviation & CAPA Management	Module 1	Day 1
Complaint handling to recall (QP involvement)	Module 1	Day 1

Lecture	Module	Day
Module 1 - Quality Management – The Role of the Qualified Person \| Day 2
Validation & qualification	Module 1	Day 2
QP Skills & Challenges	Module 1	Day 2
Trending and Management review and QP involvement	Module 1	Day 2
The QP Declaration	Module 1	Day 2
API & Excipients	Module 1	Day 2
Challenges of a QP in Industry	Module 1	Day 2
QP role in Hospital environment	Module 1	Day 2
Quality Control and the QP	Module 1	Day 2
Out-of-Specification (OOS) including batch decision: release or reject situation Casestudy	Module 1	Day 2

Lecture	Module	Day
Module 1 - Quality Management – The Role of the Qualified Person \| Day 3
The Critical Impact of Culture and Behavior: Introduction Casestudy	Module 1	Day 3
Lessons from the Case Study Quality Culture & Behaviour	Module 1	Day 3
Case Study Presentation and Discussion: Risk Management (as per ICH Q9)	Module 1	Day 3
Case Study Presentation and Discussion: Deviation Management	Module 1	Day 3
Current regulatory development and inspection highlights (IGJ)	Module 1	Day 3
Questions & Answers and Discussion	Module 1	Day 3

Lecture	Module	Day
Module 1 - Quality Management – The Role of the Qualified Person \| Day 4
Case Study Presentation and Discussion: Third Party Operations	Module 1	Day 4
Case Study Presentation and Discussion: Data Integrity	Module 1	Day 4
MAH responsibilities	Module 1	Day 4
The registration dossier - its development and life-cycle	Module 1	Day 4
The QP and the registration dossier	Module 1	Day 4
Critical points in scaling up (process from development to clinical to commercial)	Module 1	Day 4
From R&D lead to development active substance to pharmaceutical formulation Introduction to Quality by Design and Risk Management Casestudy	Module 1	Day 4

Lecture	Module	Day
Module 1 - Quality Management – The Role of the Qualified Person \| Day 5
Toxicology & HBEL's	Module 1	Day 5
GLP basics	Module 1	Day 5
Safety and Pharmacovigilance	Module 1	Day 5
Investigational Medicinal Products and the QP	Module 1	Day 5
Workshop	Module 1	Day 5
End of the training, closing remarks	Module 1	Day 5

Lecture	Module	Day
Module 2 - Quality Management in Drug Development \| Day 6
Welcome, Introduction and Personal Expectations	Module 2	Day 1
Introduction to Drug Discovery - From Patient to Target Product Profile (TPP)	Module 2	Day 1
Pharmacokinetics and pharmacodynamics (PK/PD)	Module 2	Day 1
The IMPD and the Registration Dossier	Module 2	Day 1
Getting to know the IMPD and the Registration Dossier - Where to find what information	Module 2	Day 1
Product Development for the Purpose of Non-Clinical and Clinical Studies	Module 2	Day 1
Product Development (TPP, CPP & CQA)	Module 2	Day 1
Analytical Development	Module 2	Day 1
Product & Analytical Development	Module 2	Day 1

Lecture	Module	Day
Module 2 - Quality Management in Drug Development \| Day 7
Opening and Reflection	Module 2	Day 2
Introduction GLP & Non-Clinical Studies	Module 2	Day 2
Non-Clinical Studies	Module 2	Day 2
Introduction GCP & Clinical Studies	Module 2	Day 2
GCP & Clinical Studies	Module 2	Day 2
Theory of GMP for IMP’s and its practical aspects including the role of the QP for IMP	Module 2	Day 2
From development documentation to IMPD to registration filing Changes Deviations and their impact on the regulatory dossier	Module 2	Day 2
Reflection and closure	Module 2	Day 2

Lecture	Module	Day
Module 3 - Quality Management in Sterile Manufacturing \| Day 8
Welcome and outline of the course	Module 3	Day 1
Biology of microorganisms Implications for pharmaceutical production and quality control	Module 3	Day 1
Sterile manufacturing: a philosophy on design and control	Module 3	Day 1
Environmental monitoring Case study	Module 3	Day 1
Pharmaceutical water systems and utilities	Module 3	Day 1
The gowning procedure	Module 3	Day 1

Lecture	Module	Day
Module 3 - Quality Management in Sterile Manufacturing \| Day 9
Sterilization methods: steam, dry heat Exercises for steam	Module 3	Day 2
Cleaning and desinfection	Module 3	Day 2
Sterilization methods: Filtration and alternative methods	Module 3	Day 2
Case studies: Sterility Assurance in practice	Module 3	Day 2
Contamination Control Strategy	Module 3	Day 2

Lecture	Module	Day
Module 3 - Quality Management in Sterile Manufacturing \| Day 10
Validation of aseptic processes Case studies	Module 3	Day 3
Aseptic operations in ATMP manufacture	Module 3	Day 3
Workshop: the role of the QP in assuring the quality of sterile pharmaceuticals	Module 3	Day 3
Evaluation of the course	Module 3	Day 3

Lecture	Module	Day
Module 4 - Quality Management in Biopharmaceutical Manufacturing \| Day 11
Cell line development and cell bank preparation Theory and case study	Module 4	Day 1
Upstream process development for biopharmaceutical products	Module 4	Day 1
Purification survey of unit operations and process integration	Module 4	Day 1
Welcome and introduction Opening workshop	Module 4	Day 1
Introduction to biotechnology: Applications and elements of the biotechnological production process; quality and regulatory aspects	Module 4	Day 1

Lecture	Module	Day
Module 4 - Quality Management in Biopharmaceutical Manufacturing \| Day 12
Development, tech transfer and commercial production of monoclonal antibodies by cell culture – Part 2	Module 4	Day 2
Development, tech transfer and commercial production of monoclonal antibodies by cell culture – Part 1	Module 4	Day 2
Design of an industrial process for purification of biologicals	Module 4	Day 2
Protein analytics of biopharmaceuticals: relevant assays and their principles	Module 4	Day 2

Lecture	Module	Day
Module 4 - Quality Management in Biopharmaceutical Manufacturing \| Day 13
Critical attributes and comparability studies	Module 4	Day 3
Quality challenges for Advanced Therapy Medicinal Products (ATMPs)	Module 4	Day 3
Immunogenicity and formulation of biopharmaceuticals	Module 4	Day 3
Pathogen safety	Module 4	Day 3
Biosimilars: a new class of licensed biotech products	Module 4	Day 3
Closing Workshop	Module 4	Day 3
Evaluation of the course	Module 4	Day 3

Practical Information

Difficulty / Level:: Intermediate level and Professional level
Group discounts:: 2 participants - 5%

3 participants - 10%

4 participants - 15%

4 participants - 20%

6+ participants - 25%
Languages throughout the modules:: English spoken language (primary)

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.
Learning form:: Classroom
Requires preparation:: Yes.
Every module in this series contains homework.
Includes exam:: Yes.
Exam price:: €1,400.00 ex. VAT per participant.