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

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.

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
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    Lecturer(s)

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

    Désirée Vendrig
    Christine Mitchell