eca usa change 3 update 07.01.2021

eca usa change 3 update 07.01.2021

Course No 12356789

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Dr Heinrich Prinz, PDM Consulting
Dr Gabriele Schönberger, ZS.CTIS Consulting
Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche


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


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 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 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
  • 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
  • General aspects of Quality Assurance
  • How to implement and structure a system
  • Responsibilities
  • Deviations
  • CAPA
  • Change Control
  • OOS
  • Failure Investigations
  • Self-inspections
17.00 – 17.30 h
Q&A Session 2

Programme 24 March 2021
09.00 – 09.45 h
Risk Management
  • Main topics of ICH Q 9 / Part 3 EU GMP Guideline
  • Risk management tools
  • Use of risk analysis during qualification
  • How to handle FMEA?
09.45 – 10.45 h
  • Definitions: Qualification, validation, calibration, maintenance, risk Analysis
  • Organizing qualification and validation: the validation master plan (VMP)
  • Steps in Qualification studies: DQ, IQ, OQ, PQ
  • Qualification parameters of typical types of equipment: Clean rooms, water systems, production equipment, analytical Equipment
  • Performing risk analysis: tools and practical tips
  • Calibration: critical types of Equipment
  • How to build up a calibration System
  • Maintenance: Requirements and System
10.45 – 11.00 h Break
11.00 – 12.15 h
  • Definitions
  • Process Validation
  • PAT
  • Validation Master Plan
  • Cleaning Validation
  • Computer Validation
  • Validation of Analytical Methods
12.15 – 12.45 h
Q&A Session 3

12.45 – 13.45 h Break
13.45 – 14.45 h
Audits and Self-Inspections
  • Types of audits
  • Requirements
  • Dos and don’ts for the auditee - How to survive audits?
  • Performing audits and self-inspections
  • Good audit practices
14.45 – 15.00 h Break
15.00 – 16.00 h
  • Packaging/Storage/Transportation in the regulations
  • Managing of packaging process
  • What is necessary to regulate in a pharmaceutical Company
  • WHO good storage practice – elements and requirements
  • Transportation as part of storage
  • How to maintain the quality during transportation
16.00 – 16.30 h
Falsified Products
  • Regulatory requirements
  • Responsibilities of QP and the pharmaceutical industry
  • What measures can be taken
  • Strategies against falsified products
16.30 – 17.00 h
Q&A Session 4

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