GMP for Middle Management in the Pharmaceutical Industry

4.5 rating based on 712 ratings. 712 students

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. 712 students

GMP & GDP training for pharma & biotech

Language(s):

3 days in total

 1.956 ex. VAT

Registration ends in 28 days.

The upcoming start date of this training is guaranteed.

What you'll 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

Description

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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.
Note: the edition of March 2024 will be given in English.
GMP for Middle Management has been awarded 19,5 accreditation points.

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
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Course content

LectureDay
Learning Objectives & Course Content

  • Introduction
  • Learning Objectives
  • Kahoot! Quiz
  • Learning Goals Document
1
The Pharmaceutical Industry today

  • Developments in the Pharmaceutical Industry
1
GMP Legislation and Regulations

  • History
  • Eudralex Volume 4
  • Medicine Legislation
  • Licenses
  • European Commission (EC)
  • EMA, PIC/S, ICH, FDA, WHO
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
Deviations

  • Workshop
1
Chapter 2: Personnel

  • Responsibilities Personnel
  • Importance of training
  • Introduction to quality culture
  • Human Errors
1
Closing of the day

1
LectureDay
Introduction day 2

2
Chapter 3: Premise 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 (continued)

  • Data Integrity
  • GdocP
2
Chapter 5: Production

  • Introduction
  • Critical parameters
  • Workshop: Contamination Control Strategy
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
LectureDay
Introduction day 3

3
Chapter 6: Quality control

  • Quality Control
  • Out of Specification (OOS)
  • Reference and Retention samples
  • Sampling
3
Chapter 7: Outsourced activities

  • Outsourcing work
  • Qualification of Suppliers and Contract Acceptors
3
Computer Systems

  • Annex 11 & Validation
  • Critical points after validation
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

Course dates

Start dateEnd dateVenuePriceStatus
19-03-202421-03-2024Van der Valk Breukelen 1.956 ex. VATRegistration closed
14-05-202416-05-2024Van der Valk Breukelen 1.956 ex. VATRegister
17-09-202419-09-2024Van der Valk Breukelen 1.956 ex. VATRegister
02-12-202404-12-2024Van der Valk Utrecht 1.956 ex. VATRegister

Language

  • Dutch spoken language
  • English spoken language

General information

Learning form:Classroom
Times:The course starts at 9:00 am and ends at 5:30 pm
Venue(s):
Start dateVenueRegister

19-03-2024

Van der Valk Breukelen

Register

14-05-2024

Van der Valk Breukelen

Register

17-09-2024

Van der Valk Breukelen

Register

02-12-2024

Van der Valk Utrecht

Register

Preparation:
Preparation required:Preparation requirements to be announced
Preparation details:N/A
Exam:
Includes exam:No
GMP for Middle Management in the Pharmaceutical Industry thumbnail
 1.956 ex. VAT

Registration ends in 28 days.

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

Course dinner

28 Lectures

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