The 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 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 Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
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
Hygiene / Personnel Hygiene
General aspects and rules
Hygiene program
Personnel flow
Medical examination
Contamination
Monitoring
Personnel and Training
General aspects
Qualification
Key personnel
Job descriptions
Training (purpose, goals, contents, target groups)
Planning and documentation of training
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
Premises / Production
Requirements for room and equipment
Classification of rooms
Sterile production/Isolator
Maintenance of hygiene
How to behave during production
General & Specific Aspects of a QA System
Quality Management System (QMS) cited in the regulations
Testimonials