GMP for Supporting Personnel

4 rating based on 143 ratings. 143 students

GMP for Supporting Personnel

Basisprincipes en overzicht van Good Manufacturing Practice (GMP) regelgeving

4 rating based on 143 ratings. 143 students

GMP & GDP training for pharma & biotech

Language(s):

1 day in total

 922 ex. VAT

Registration ends in 136 days.

The upcoming start date of this training is guaranteed.

What you'll learn

Look up the laws and regulations yourself

Translate various GMP rules to your own practice

Indicate requirements for working in a GMP environment (basic)

Description

The training

One-day training with the basic principles and an overview of Good Manufacturing Practice (GMP) regulations.
Most GMP training courses are aimed at operators, analysts and people working within the quality department and are therefore less suitable for people from the periphery. But employees of pharmaceutical companies whose activities are more indirectly related to GMP must also have knowledge of GMP. Think, for example, of employees of purchasing, sales, production planning, human resources, documentation and secretaries. Despite the fact that they do not produce or analyze medicines themselves, their involvement in the production of high-quality medicines or in maintaining a well-functioning quality system is certainly important. Ultimately, they are often a direct or indirect player in one or more quality systems and their activities contribute to the proper functioning of the company. For this reason, PCS has developed a 1-day course that focuses on those parts that provide a good general understanding of what is involved in the development, production and analysis of medicines.

Target group

This training is intended for employees of pharmaceutical companies who are more involved with GMP in the background. This includes employees of the purchasing, sales, finance, marketing, logistics, documentation or human resources departments, as well as planners and secretaries.

Learning objectives

  • Have a basic understanding of the contents and the importance of the GMP regulations
  • Understand how a Quality Management System (QMS) is set-up in a GMP environment
  • Indicate requirements for working in a GMP environment (basic)
  • Being able to look up the laws and regulations yourself
  • Translating different GMP rules into your own practice

Results

  • Understanding the main responsibilities of a pharmaceutical manufacturer
  • Awareness of the importance of GMP
  • Basic understanding of GMP requirements

Content

  • Why GMP?
  • Current EU rules and practical implications
  • Insight into which systems are needed
  • Key Quality System Elements (incl. Change Control, Deviations, CAPAs and Risk Management)
  • Documentation and Data Integrity
  • GMP in your own practice
Course content

LectureDay
Introduction to the course

1
GMP - Why do we do it?

1
Legislation of the pharmaceutical industry

  • Dutch laws and regulations
  • Europe, FDA, PIC/S, ICH
1
Pharmaceutical supply chain

  • 6 steps in the pharmaceutical supply chain
1
GMP Building Blocks

  • Workshop
1
Quality System

  • Quality & Quality system
  • Basic quality system elements: change control, deviations, CAPAs, risk management
1
Documentation and Data Integrity

  • The goal of documentation
  • GMP documents
  • Raw Data and Good Documentation Practices
1
Workshop GMP

  • Workshop
1
GMP in your own practice

1
Quiz & Closure

1

Course dates

Start dateEnd dateVenuePriceStatus
10-10-202410-10-2024Van der Valk Breukelen 922 ex. VATRegister

Language

  • Dutch spoken language

General information

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

10-10-2024

Van der Valk Breukelen

Register

Preparation:
Preparation required:Preparation requirements to be announced
Preparation details:N/A
Exam:
Includes exam:No
GMP for Supporting Personnel thumbnail
 922 ex. VAT

Registration ends in 136 days.

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

10 Lectures

Training 5 people or more?

In-house training may be your best choice! We have more than 100 GxP training courses on demand.