Public-registration training

GMP for Middle Management in the Pharmaceutical Industry

4.5 rating based on 712 ratings 4.5 rating based on 712 ratings.
This training provides an overview of key aspects of quality control for middle management level

This training includes:

Upcoming edition starts 19-09-2023
Register now!

GMP for Middle Management in the Pharmaceutical Industry

This training provides an overview of key aspects of quality control for middle management level

4.5 rating based on 712 ratings 4.5 rating based on 712 ratings.

3 days in total
712 students
Upcoming edition starts 19-09-2023

GMP for Middle Management in the Pharmaceutical Industry

What you will learn

Implementing GMP in practice, including Quality Culture

Effectively dealing with the specific position of middle management in a pharmaceutical organization

Appoint the importance and essence of GMP through a thorough overview of laws and regulations

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Training language(s)

Training description

The training

This three-day course provides an overview of key aspects of quality control for the Middle Management.

This proven course provides an overview of key aspects of quality control. Knowledge and insight of middle management level employees plays an indispensable role here. Precisely this group is often intensively involved in setting up, improving and applying quality systems. This training covers the essential elements of a quality system and supporting activities such as validation, qualification and change control.

This year the course content has been adapted to the most recent developments in the field of GMP with respect to the changes in the European directives.

Target audience

Especially QA Officers & Managers, QPs, QC Managers & Analysts and Production Managers or Supervisors frequently attend this training. HBO/WO level.

Learning objectives

  • Identify the importance and essence of GMP through a thorough overview of laws and regulations.
  • Implement GMP in practice, including Quality Culture
  • Effectively deal with the specific position of middle management in a pharmaceutical organization.

Results

  • GMP is easier to interpret and translate into practice
  • Insight into “gaps” within the organization
  • Awareness of the importance of GMP in daily activities

Content

  • Law and Regulations
  • Quality Culture
  • Quality Systems
  • Documentation and Data Integrity
  • Validation
  • Raw materials and APIs
  • Pharmaceutical manufacturing (including packaging)
  • Quality Control
  • Outsourcing activities
  • Complaints and Recalls
  • Storage and Distribution
  • Experiences from the IGJ
  • GMP in your own practice

Training program

28 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 31
Program - Day 2
Program - Day 3
Program - eLearning Component
LectureSub-lectures
Program - Day 1
LectureSub-lecturesDay
Learning Objectives & Course Content

  • Introduction
  • Learning Objectives
  • Kahoot! Quiz
  • Learning Goals Document
    		• 1
    Chapter 1: Pharmaceutical Quality System

  • Quality Systems
  • Modern GMP
    		• 1
    Chapter 1: Pharmaceutical Quality System The Essential Elements

  • Change Control
  • Deviations
  • CAPAs
  • Risk Management
    		• 1
    Chapter 2: Personnel

  • Responsibilities Personnel
  • Importance of training
  • Introduction to quality culture
  • Human Errors
    		• 1
    Deviations

  • Workshop
    		• 1
    Closing of the day

    		1
    Program - Day 2
    LectureSub-lecturesDay
    Introduction day 2

    		2
    Chapter 3: Building and Equipment

  • Introduction
    		• 2
    Equipment, Validation, Calibration and Verification

  • Equipment
  • What is Validation, Calibration and Verification?
  • Validation according to Primary Process & V-model
  • Examples
  • Cleaning Validation
    		• 2
    Chapter 4: Documentation

  • GMP documentation
    		• 2
    Supervision of companies

  • Supervision of companies
    		• 2
    Chapter 4: Documentation

  • Data Integrity and GDocP
    		• 2
    Chapter 5: Production

  • Introduction
    		• 2
    Critical Process Steps (CPP & CQA).

  • Workshop
    		• 2
    Risk Ranking

  • Input materials and suppliers
  • Workshop
    		• 2
    The Role of the Qualified Person

  • Regulation
  • Responsibilities
  • Qualification of a QP
  • Release process
    		• 2
    Closing of the day

    		2
    Program - Day 3
    LectureSub-lecturesDay
    Introduction day 3

    		3
    Chapter 6: Quality control

  • Quality Control in GMP
  • QA versus QC
  • Sampling
  • Reference and Retention samples
  • Out of Specification (OOS)
    		• 3
    Computer Systems

  • Annex 11 & Validation
  • Critical points after validation
    		• 3
    Chapter 7: Outsourced activities

  • Outsourcing work
  • Kwalificatie van Leveranciers en Contract Acceptors
    		• 3
    Chapter 8: Complaints, returns and product recall

    		3
    Chapter 9: Self-inspection

    		3
    Workshop - What went wrong?

  • Analysis of consequences and actions to be taken in case of inadequate quality management system
    		• 3
    Workshop discussion

    		3
    GMP in you own practive

    		3
    Quiz & afsluiting

    		3
    Program - Day 4
    LectureSub-lecturesDay

    Training date(s)

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    Lecturer(s)

    Karen Zimmermann