Who Should Attend

Successful specification, design, installation, validation, management and control of a pharmaceutical water system depends on a coordinated, multi-disciplinary approach.  The course will be valuable for those in pharmaceutical, biotechnology and medical device manufacturing who are responsible for or involved in:

• Specification and engineering design
• Technical and validation support
• Regulatory compliance activities and auditing
• Risk assessment, troubleshooting and system improvement
• Water system operation, management and maintenance
• Quality assurance and validation management
• Quality control, sampling, microbiological and chemical analysis

• Understand the water types, qualities, uses and applications in pharmaceuticals, biotechnology and medical device manufacture
• Be familiar with the applications and limitations of the range of treatment technologies and able to choose the most effective combination of techniques for your needs
• Appreciate the importance of a “common-sense” approach to the implementation of cost-effective design solutions
• Be aware of the GMP requirements and regulatory expectations relating to water systems and their validation requirements
• Have gained a practical understanding of systems via examples and discussions
• Have developed better knowledge and understanding between the different disciplines involved in the operation and management of water systems

The course will also provide interactive workshops and a discussion forum to enable delegates to exchange ideas and experience.

Course Description

This course provides an interactive mix of lectures, workshops and discussions intended to highlight basic principles and technologies and how these are applied in practice to pharmaceutical water systems. The benefits from applying the principles discussed during the course will include:

• Minimize time spent in troubleshooting deviations and failures
• Set appropriate alert and action limits to avoid costly batch contamination
• Avoid regulatory agency’s observations and compliance issues and reduce inspection frequencies by building a history of compliance

The course is intended to raise practical understanding and awareness for water system owners and managers, QA managers, regulatory compliance staff, microbiologists, engineers, validation specialists and operators.



View Course Agenda



Past Participants' Comments

“Learned more in two days in this course than in 4 years of undergraduate studies!”
Mel C., Microbiologist, Dentsply Pharmaceuticals

“It was great to have an instructor with the depth of knowledge and experience that this instructor has.  He is able to answer most questions with specific, real-life examples, which adds relevance.”
John B., Deputy Director of Equipment Technology, Sanofi-Pasteur

“Compared to other industry-related courses/workshops I have attended through other institutions, this has been the best by far.  Excellent venue.  I look forward to attending future CfPIE sponsored events for continuing education and professional development.” 
Martin B., QC Scientist II, Wyeth Biopharma

“Excellent, comprehensive course.  Material presented in thorough, clear manner; the instructor was very knowledgeable and skilled in presenting.  I found the course very useful.” 
Roger A., Director of Quality & Tech. Svcs., Helvoet Pharma

“Very helpful course.  Having no experience in this field, I left feeling I had achieved the basic knowledge that I could build upon.  It is very intensive as far as information.” 
Cara M., Microbiological/QA Supervisor, Cook Biotech

“Very informative!  I attended a similar course about 8 years ago and this course was a great refresher.  The course director was an excellent instructor who interacted well with the class and sought questions related to specific situations we have been involved with.” 
Kevin S., Calibration Coordinator, Bristol Myers Squibb

“Very in-depth course.  Course leader very knowledgeable on all subjects.  Capable of answering any question thrown at him.  All slides were very clear and interactive.” 
Carol C., QC Microbiologist, Genzyme Ireland Ltd.