Public-registration training

Quality Management – The Role of the Qualified Person

4.5 rating based on 617 ratings 4.5 rating based on 617 ratings.
Quality Management - The role of the Qualified Person

This training includes:

Upcoming edition starts 18-04-2023
Register now!

Quality Management – The Role of the Qualified Person

Quality Management - The role of the Qualified Person

4.5 rating based on 617 ratings 4.5 rating based on 617 ratings.

5 days in total
617 students
Upcoming edition starts 18-04-2023

Quality Management – The Role of the Qualified Person

What you will learn

Identify elements of applicable GMP regulations and GMP expectations across the product life-cycle

Understand current regulatory developments and their business impact, e.g., new regulations, the Falsified Medicines Directive (serialization) and significant issues that may impact the business (data integrity, drug shortages and supply chain integrity),

Apply the basic principles of quality management from a regulatory and business perspective

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Training language(s)

Training description

The training

 

The Qualified Person watches over product quality while taking patient safety and product availability into account. This requires an in-depth understanding of the role and responsibilities of the Qualified Person.Previously organized by PAO Farmacie, now by PCS Academy.

Target audience

 

Professionals in pharmaceutical and biotechnological industries, Professionals in institutions and CRO’s, Hospital pharmacists and Postgraduate students.The training is aimed at (young) professionals in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control and Quality Assurance 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 training is an international training program in English and requires, at minimum, a Bachelor’s Degree level (HBO level in the Netherlands).

Accreditation will be sought with the NVZA and KNMP (hospital and public pharmacists).

What is the training about?

This training provides insight into an integrated approach on quality management as a good business practice in the pharmaceutical and biotechnological industries and hospitals to safeguard the quality of their products. There will be a focus on the role and responsibilities of the Qualified Person (QP) as well as on legislation, guidelines and best practices.
We will also discuss common challenges a QP encounters in his/her day-to-day activities. You will participate in a team to work out a case study in the period between the first and second training sessions.

Training structure

 

This training is of an advanced level. A basic level of GMP knowledge is required to attend this training. The training program is not designed to address the basic theoretical principles of GMP.The practical implication of the GMP principles, real-life cases and the role of the QP are the focus of this training.

We therefore strongly recommend following this training in conjunction with the “GMP voor het Middenkader” training, the upcoming edition of “GMP voor het Middenkader” will be held on 21-23 March 2023. Participation in “GMP voor het Middenkader” is offered at the reduced rate of €1250.- ex. VAT when purchased together with this training.

“GMP voor het Middenkader” is a proven training that provides an overview of the key aspects of quality management. All nine chapters of the GMP are covered, laying an important foundation for this training; Quality Management – the role of the QP .

If you have a sufficient level of GMP knowledge going into this training, it is possible to obtain exemption from following “GMP voor het Middenkader” by taking a multiple-choice test. The result of this test is non-binding.

A Qualified Person is expected to be aware of a number of pre-approval elements, which is why have incorporated a new set of elements in this module; an overview of the product life-cycle, Toxicology and the Registration Dossier.

The training is highly interactive. The program is offered as a combination of self-study, theory, and practical case studies. The self-study prior to the module consists of reading and following eLearnings.

Content
·       Quality Management as a good business practice across the product life-cycle
·       Basic Principles of Quality Management
·       The specific regulatory role and responsibility of the Qualified Person
·       Quality Management System elements: deviation management, change control, RCA, validation & qualification, training and qualification of personnel, customer complaint management, audit systems and third-party operations
·       Similarities and differences between local (small) organizations and global (large) organizations
·       Current regulatory developments and (IGJ) inspection highlights
·       The critical impact of culture and behavior on compliance
·       Trending, Management Reviews and QP involvement
·       The Registration Dossier: it’s development, life-cycle and the role of the QP
·       Toxicology, including Health Based Exposure Limits
·       From development to clinical to commercial
·       QP experiences
·       Industry, hospital environment, international setting
·       Real-life challenges such as QP declarations and drug shortage prevention
·       Real-life case studies
·       Including participation in a team to work out a case study in the period between the first and second training sessions.

Training program

36 lectures in total. The program is subject to change. The final program will be sent to the participants approximately 1 week before the start of the training. No rights can be derived from this program.

eLearning
Program - Day 1
Program - Day 2
Program - Day 3
Program - Day 4
Program - Day 5
Program - eLearning Component
LectureSub-lectures
Program - Day 1
LectureSub-lecturesDay
Introduction: The Roles and duties of the Qualified Person in Pharmaceutical Quality Management (Annex 16 and importation)

1
Roadmap to realize Sustainable Quality and Regulatory Compliance Performance The Specific Regulatory Role and Responsibility of Senior Management, the QP and RP (IGJ)

1
Deviation & CAPA Management with RCA Case

  • Case study
    		• 1
    Change Control

  • Case study
    		• 1
    Complaint handling to recall (QP involvement)

    		1
    QP skills & challenges

    		1
    Training, Qualifications and roles & Responsibilities

  • Workshop
    		• 1
    Program - Day 2
    LectureSub-lecturesDay
    Validation & qualification

  • Case met validatieprotocol/rapport
    		• 2
    API & Excipients and RCA's

    		2
    QP Declaration

    		2
    Trending and Management review and QP involvement

    		2
    Dilema's of an international QP

    		2
    Challenges of a QP in Industry

    		2
    Grey area QP role in Hospital environment

    		2
    QC

    		2
    OOS and batch decision: release or reject

  • Case
    		• 2
    Program - Day 3
    LectureSub-lecturesDay
    Quality Culture & Behavior

  • Theory and workshop
    		• 3
    Lessons from the Case Study Quality Culture & Behavior

    		3
    Risk Management

    		3
    Deviations

    		3
    Current regulatory development and inspection highlights (IGJ)

    		3
    Q & A session

    		3
    Program - Day 4
    LectureSub-lecturesDay
    3rd party operations

    		4
    Data Integrity

    		4
    MAH responsibilities

    		4
    The registration dossier - its development and life-cycle

    		4
    The QP and the registration dossier

    		4
    Drug shortages prevention (CBG)

    		4
    From R&D lead to development active substance to pharmaceutical formulati

  • Presentation and case study
    		• 4
    Program - Day 5
    LectureSub-lecturesDay
    The critical points in scaling-up (process from development to clinical to commercial)

    		5
    Toxicology & HBEL's

    		5
    GLP basics

    		5
    The role of the QP in clinical studies (GCP)

  • Presentation and workshop
    		• 5
    Safety and Pharmacovigilance

    		5
    Workshop

    		5
    Closure

    		5

    Training date(s)

    Start dateEnd dateVenuePriceStatus
    18-04-202325-05-2023Van der Valk Amersfoort€ 3.225 ex. VATOpen for registration
    Option 1 € 3.225 ex. VAT
    Start date:

    18-04-2023

    End date:

    25-05-2023

    Venue to be announcedRegistration open
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    Lecturer(s)

    Désirée Vendrig
    Désirée Vendrig
    Module Leader, Senior GMP/GDP Consultant & Trainer

    Désirée is an independent GxP consultant with 30+ years experience in the pharmaceutical industry. Désirée fulfilled various Global Quality positions at Teva Pharmaceuticals between October 2004 and January 2018 and was responsible for the quality and compliance of Teva commercial and clinical trial products distributed in Europe and the EMIA-APAC region as well as for quality oversight of third-party manufacturers. Her last assignment was Global Head of Quality for PGT Healthcare, a joint venture between Procter and Gamble and Teva for OTC products. She represented Teva as Co-Chair in the Quality and Compliance Working group of Medicines for Europe and attended several meetings with the Europe Medicines Agency. From 1995 to 2004 Désirée was Senior GMP inspector at the Dutch Healthcare lnspectorate in Haarlem and The Hague. She attended lnspectors Working Party meetings in London and PIC/S conferences, and was involved in the implementation of the Clinical Trial Directive into the Dutch legislation. She started her career in the pharmaceutical industry by joining Solvay Pharmaceuticals (now Abbott) in Weesp, The Netherlands in 1988 as Head of the R&D Pharmaceutical Analysis Department. In this role she was among others responsible for the release of raw materials and finished products for pre-clinical and clinical trials. Désirée graduated in 1985 as a pharmacist at the State University of Utrecht, The Netherlands. In the same year she started her PhD study at the Faculty of Pharmacy of the University of Utrecht resulting in the thesis titled Bioanalysis Stability, Pharmacokinetics and Electrochemistry of Vinca Alkaloids. During her period at the Faculty of Pharmacy, Désirée delivered practical education to Pharmacy students. She has given more than 15 years' GMP lectures fora post-academie course on Radiopharmacy organised by the European Association of Nuclear Medicine (EANM) and regularly lectures on GMP and GDP at national and international courses and conferences. She works as an independent consultant.
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    Christine Mitchell
    Christine Mitchell
    Module Leader, Senior GCP/GLP Consultant & Trainer

    Christine has provided Quality Assurance regulatory compliance support for over 35 years. She has presented at international conferences and participated in various OECD GLP expert working groups. This involved updating the OECD GLPs and developing OECD GLP consensus documents for short-term studies and multi-site studies.
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    Désirée Vendrig
    Christine Mitchell