Dr. Wolfgang Schumacher
formerly F. Hoffmann-La Roche
Referent:innen
Dr. Gabriele Schönberger
formerly Boehringer Ingelheim
Dr. Heinrich Prinz
PDM Consulting
Note: All times mentioned are CEST. To get an impression, please take a look at the preview of this Training Course. Click here to have an overview of all dates for this training course.
Zielsetzung
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
Hintergrund
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 ….
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…..
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.
Zielgruppe
The Online Training is directed to staff from the pharmaceutical industry having no or little experience with the current GMP requirements. This includes both employees who, after their vocational training, enter the pharmaceutical industry and experienced colleagues who work for the first time in a GMP-regulated environment. Participation is also recommended for personnel from suppliers who have to understand the quality requirements of their customers.
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you Need to participate in our events and you can check if your System meets the necessary requirements to participate. If the Installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Programme 15 October 2024
Welcome & Introduction
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
Q&A Session 1
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
- General aspects of Quality Assurance
- How to implement and structure a system
- Responsibilities
- Deviations
- CAPA
- Change Control
- OOS
- Failure Investigations
- Self-inspections
Q&A Session 2
Programme 16 October 2024
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?
Qualification/Calibration/Maintenance
- Definitions: Qualification, calibration, maintenance
- Organizing qualification
- 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
Validation
- Definitions
- Process Validation
- PAT
- Validation Master Plan (VMP)
- Cleaning Validation
- Computer Validation
- Validation of Analytical Methods
Q&A Session 3
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
Packaging/Storage/Transportation
- 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
Falsified Products
- Regulatory requirements
- Responsibilities of QP and the pharmaceutical industry
- What measures can be taken
- Strategies against falsified products
Q&A Session 4
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