GMP for Beginners in Sterile Manufacturing - Live Online Training
24/25 September 2024
Course No. 21329
Speakers
Dr. Florian Witte
Boehringer Ingelheim
Wolf-Dieter Wanner
Consultant
Dr. Björn Wiese
Janssen Cilag
Michael Grosser
Lonza Biologics
Note: All times mentioned are CEST.
Objectives
The Online Training is designed for people working in sterile manufacturing to get basic knowledge of GMP.
You get to know the most important pharmaceutical regulations for sterile manufacturing and their importance,
You get a basic overview of general GMP requirements and specific requirements in sterile manufacturing and
You become familiar with the most important basic processes in sterile pharmaceutical production.
Background
Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products and medical devices. Particularly in the manufacture of sterile medicinal products, employees have to comply with extensive requirements. Against this background, employees have to know the GMP requirements and must know how to use them in practice.
The question is: how can employees implement in their daily work regulations which are usually formulated in a very general manner?
The aim of the Online Training is to help answer this question and enable the concrete transfer of regulatory requirements into practice. Where are the main difficulties and how can they be solved pragmatically? The Online Training will present elements and situations which employees are regularly confronted with, like for example:
Correct cleaning / disinfection
Behaviour in clean rooms
Correctly passing into the clean rooms
Environmental Monitoring
Performance of Media Fills
Target Group
The Online Training is directed to staff from the healthcare industry having no or little experience with the current GMP requirements for sterile manufacturing. This includes both employees who, after their vocational training, enter the pharmaceutical industry and experienced colleagues who work for the first time in sterile manufacturing areas. Suppliers who have to understand the quality requirements of their customers should also attend this Online Training.
Technical Requirements
For our Live Online Training Courses 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 plugin. 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.
Introduction – What is Specific for Sterile Manufacturing?
What does sterile actually mean?
Controlling raw material supply
Sterilisation
Sterile Manufacturing Facilities
Process simulations
Microbiological control
Regulations for Sterile Manufacturing
Overview of regulation hierarchy
Regulations on Aseptic Processing
Applicable ISO standards
Microbiological Basics
Characteristics of microorganisms
Microbial growth
Microbial identification techniques
Detection methods and their limitations
Clean Rooms and Barrier Systems
Differences in the technology
Decontamination vs. Disinfection
Validation aspects
Environmental monitoring
Risk considerations
Specific Training Requirements for Sterile Manufacturing
Basics of microbiology
Contamination sources and -transfer
Clean rooms
Hygienic behaviour
Cleaning and Disinfection
Definitions
Requirements - results – parameters
Types of detergents and disinfectants
Microbiological efficacy
Compatibility of materials
Types of application
Surface wetting
Hygiene
General definitions
Purpose and function to pharmaceutical manufacturing with reference to personnel, surfaces, equipment
Diversity of hazard – hazard analysis
Clean room conception
Gowning procedures
Decontamination procedures
Case Study: Entering the Clean Area
Requirements
How to meet the criteria - practice
Entering a clean area is a very critical step to fulfil the GMP requirements. Employees must be trained and qualified and the gowning process must be validated. Attendees will learn different procedures and discuss the advantages and disadvantages.
Sterilisation Processes
Controlling bioburden / pyroburden
Autoclaving
Filtration
Dry heat
Gamma irradiation
Ethylene Oxide
Involvement of the Microbiological Lab
Counting micro-organisms
Identifying micro-organisms
Process validation
Validating the sterility test
Raw material testing strategy
Trouble Shooting
Environmental Monitoring
Regulatory requirements
Content and establishing of an environmental monitoring program
Requirements concerning media and media suppliers
Documentation and trending
Media Fill
Regulatory requirements
Microbiological media types
Process simulation contamination
Sample incubation
Laboratory work
Formal report
Handling failures in Sterile Manufacturing
Historic background
Regulatory Requirements
Example for a Non-conformity System
Case studies
Case Studies „Establishing an Environmental Monitoring Program and Handling of Failures in Microbiology“ Some practical examples from a pharmaceutical company will be demonstrated and discussed with the attendees.
Inspections / Audits / Observations
Preparing for a formal inspection
Managing an FDA audit of sterile manufacturing
Internal audit program
Real world observations
Your OOS and OOT process
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager" Learn more
Testimonials
Seminar Programme as PDF