Quality Management – The Role of the Qualified Person

4.5 rating based on 617 ratings. 617 students

Quality Management – The Role of the Qualified Person

Quality Management - exploring the role of the Qualified Person

4.5 rating based on 617 ratings. 617 students

GMP & GDP training for pharma & biotech

Language(s):

5 days in total

 3.225 ex. VAT

Registration ends in 9 days.

The upcoming start date of this training is guaranteed.

What you'll 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

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. This training is divided into two parts:
  1. April 9 to April 10 2024,
  2. May 14 to May 16 2024.
The total duration is five days.

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).

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 in March. 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.
Course content

LectureDay
Introduction: The Roles and duties of the Qualified Person in Pharmaceutical Quality Management

1
Roadmap to realize Sustainable Quality and Regulatory Compliance Performance (IGJ)

1
Training, Qualifications and Roles & Responsibilities

1
Change Control

1
Deviation & CAPA Management

1
Complaint handling to recall (QP involvement)

1
LectureDay
Validation & qualification

2
QP Skills & Challenges

2
Trending and Management review and QP involvement

2
The QP Declaration

2
API & Excipients

2
Challenges of a QP in Industry

2
QP role in Hospital environment

2
Quality Control and the QP

2
Out-of-Specification (OOS) including batch decision: release or reject situation

  • Case Study
2
LectureDay
The Critical Impact of Culture and Behavior: Introduction

  • Case Study
3
Lessons from the Case Study Quality Culture & Behaviour

3
Case Study Presentation and Discussion: Risk Management (as per ICH Q9)

3
Case Study Presentation and Discussion: Deviation Management

3
Current regulatory development and inspection highlights (IGJ)

3
Questions & Answers and Discussion

3
LectureDay
Case Study Presentation and Discussion: Third Party Operations

4
Case Study Presentation and Discussion: Data Integrity

4
MAH responsibilities

4
The registration dossier - its development and life-cycle

4
The QP and the registration dossier

4
Critical points in scaling up (process from development to clinical to commercial)

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

  • Introduction to Quality by Design and Risk Management
  • Case Study
4
LectureDay
Toxicology & HBEL's

5
GLP basics

5
Safety and Pharmacovigilance

5
Investigational Medicinal Products and the QP

5
Workshop

5
Closure

5

Course dates

Start dateEnd dateVenuePriceStatus
09-04-202416-05-2024Van der Valk Breukelen 3.225 ex. VATRegister

Language

  • Dutch secondary spoken language
    Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
  • English spoken language

General information

Learning form:Classroom
Times:The course starts at approx. 9:30 am and ends at approx. 5:30 pm
Venue(s):
Start dateVenueRegister

09-04-2024

Van der Valk Breukelen

Register

Preparation:
Preparation required:Yes
Preparation details:Homework
Exam:
Includes exam:Yes
Exam optional:Yes
Re-examination possible:Yes
Exam fee in course price:No
Examination fee for each exam attempt:350

Quality Course modules

This module is part of a series called: Quality Management in Pharma and Biotech. This series is designed to give participants an in-depth understanding of the QP’s role and responsibilities. See the other modules in this series below.

4.1 560  2.590 ex. VAT
4.1 455  2.590 ex. VAT
4.3 617  3.225 ex. VAT
3.7 343  2.280 ex. VAT
Quality Management – The Role of the Qualified Person thumbnail
 3.225 ex. VAT

Registration ends in 9 days.

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

Course dinner

34 Lectures

Training 5 people or more?

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