Pharmaceutical Water System Design, Operation, & Validation
For Plant Operators, Engineers, and Managers
Course Description
Objectives
The objective of this intensive education course is to enable the participants to pay optimal attention to critical issues during design, qualification and routine operation of pharmaceutical water systems.
You will learn:
- How to meet the pharmacopoeial requirements
- How to find the critical design aspects in a water system
- How to generate pharmaceutical water and steam in the desired quality
- How commissioning and qualification is done today
- How microbial validation and control is achieved
- How the systems is maintained in a controlled status during its life cycle
Overview
Water is one of the most important raw materials in the manufacture of pharmaceutical products. In order to produce water of appropriate quality, water systems have to fulfill considerable requirements, which are partly set out in detail in the relevant pharmaceutical regulations. Although the characteristics of pharmaceutical waters are sufficiently defined, a large number of questions remain unanswered as regards to the technical implementation of these bodies of regulations in GMP-conform water systems.
The main focus of the course ‘Pharmaceutical Water’ is therefore on how to put these requirements into practice. In their lectures, experienced specialists will give you important information and support for your own projects and systems, ranging from regulatory requirements, design, qualification, validation, and routine operation.
WHO IS THIS TRAINING COURSE FOR?
This GMP course is directed to engineers, production, and QA/QC staff, responsible for the design, validation, and operation of pharmaceutical water systems as well as system suppliers and design engineers.
DAY ONE
Introduction to Water
- Chemistry
- Physics
- Microbiology
Measurement of Water Quality
- Definitions of Water Types, Quality, Measurement Regulatory Standards for Water
- General
International Standards and Harmonization Strategies
DAY TWO
Designof Water Purification Systems
- Determination of Water Required for Specific applications
- Basic DesignStrategies
- Pre-treatment, Post-treatment issues
- treatment options
Deionization (Stills vs Membranes vs Ion Exchange)
- Choice/Integration of Stills Distribution Systems
- Water Storage
- Hot vs. Cold vs. Intermittent Hot, Options
- Points-of-UseDesign
- Materials of Construction
Active learning:
- Options in Water System Design Acceptable, Good, and Poor Design Choices
DAY THREE
Validation
- Regulatory Requirements and GMP Philosophies
- ValidationStrategies
- QA Protocols
- Validation Program
Start-up,Revalidation, ValidationIssues
- Sampling/TestingRoutines
- Revalidation Frequencies OperationalIssuesand Maintenance
- Sanitization/Sterilization
- Maintenance
- Troubleshooting
Emerging Trends
- New Regulatory Requirements, Technologies
CERTIFICATION
Successful participants will receive Peganix’s Certificate of Completion.
All attendees to a Peganix accredited course receive a Certificate of Accreditation acknowledging their training and their journey to New Skills, New Thinking. Independent research has verified that this recognition is highly valued by your employees.
In-person / On Location
Our team and, your health and safety are our top priority. We have limited our registration numbers to 25 people per meeting to provide enough distance per person, hand sanitizers with face masks will be provided for all attending delegates and a temperature scanner will be available at the venue.
Our team and the venue are fully prepared to assist you.
Live Online / Virtual
Registered delegates can log in and join the live meeting. The online platform will not limit your participation, as you can engage on the platform via live chat text, audio, or video. All live meetings will be recorded and made available to all participants.
At any point, you’re not feeling too well to attend the in-person meeting you can simply log in at home and join live online.
- 23rd, 24th & 25th June 2021
- Cape Town, South Africa
- In-Person
- Virtual
-
ZAR5, 999.00 (Virtual)
ZAR10, 999.00 (In-Person)
Contact Us
- registration@peganix.com
- +2711 041 0181
- +2768 053 6221