Dr Heinrich Prinz, PDM Consulting Dr Gabriele Schönberger, ZS.CTIS Consulting Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche
Objectives
The Live Online Training is designed for people who have no or Little knowledge of GMP.
You get to know the most important pharmaceutical regulations and their importance,
you get a basic overview of GMP requirements in pharmaceutical production, and
you become familiar with technical terms from the field of GMP and their meaning
Background
In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect for manufacturing high quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP requirements. The relevant European GMP regulations define the following prerequisites:
Commisson directive 2003/94/EC The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice ….
EudraLex Vol. 4 Good manufacturing practice (GMP) guidelines 2.9 Besides the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them…..
In practice, many members of staff are often unaware of the Contents and meaning of the different GMP requirements from Europe and US and their consequences for product quality. During this course, Speakers with long-standing experience in the training of employees introduce and explain the most important elements of a pharmaceutical GMP system in an easy-to-understand way.
Target Group
The Live Online Training is designed for people who have no or Little knowledge of GMP.
You get to know the most important pharmaceutical regulations and their importance,
you get a basic overview of GMP requirements in pharmaceutical production, and
you become familiar with technical terms from the field of GMP and their meaning
Technical Requirements
For our live online trainings and webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
Programme 23 March 2021
09.00 – 09.15 h Welcome & Introduction
09.15 – 10.15 h
GMP History & Trends
Development of GMPs
GMP: Goal and general ideas
Types of regulatory documents and their meaning
The Dossier
GMP for APIs, medicinal products and excipients - a comparison
Authorities and industry groups: ICH, PIC/S, EMA, FDA, WHO, APIC, ISPE, IPEC
Ph. Eur. & USP
GMP in the US: Comparison of US and EU regulations
Differences between European and FDA view on GMP / GMP vs cGMP
Typical expectations of FDA and European inspectors
10.15 – 10.30 h Break
10.30 – 11.15 h
Hygiene / Personnel Hygiene
General aspects and rules
Hygiene program
Personnel flow
Medical examination
Contamination
Monitoring
11.15 – 12.00 h
Personnel and Training
General aspects
Qualification
Key personnel
Job descriptions
Training (purpose, goals, contents, target groups)
Planning and documentation of training
12.00 – 12.30 h Q&A Session 1
12.30 – 13.30 h Break
13.30 – 15.00 h
Documentation
Structure of documentation
Responsibilities for the documentation
SOP
Documentation in the manufacturing process
Documentation in the quality control
Batch record Review
Annual report / Product quality Report
Specifications
15.00 – 15.15 h Break
15.15 – 16.00 h Premises / Production
Requirements for room and equipment
Classification of rooms
Sterile production/Isolator
Maintenance of hygiene
How to behave during production
16.00 – 17.00 h
General & Specific Aspects of a QA System
Quality Management System (QMS) cited in the regulations
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials