Pharma / BiotechSkin & Cosmetics
The course consists of interactive lectures, discussions, and imbedded exercises. Participants will also be placed in several real life situations where they complete a compliance review of a schematic process flow diagram, analyze failures using trend reports, critique a risk assessment, and perform a change control analysis including the impact of requested or proposed modifications.
The course is designed to provide the attendee with a practical understanding of the following topics:
This course is designed for Regulatory, Quality, Compliance, Validation, R&D, Clinical, Manufacturing, Engineering, Maintenance, and Management personnel who are functioning as inspectors, auditors, investigators, sample analyzers, operators, and end-users as well as those in a project team or project management roles.
This two-day program will provide you with the training needed to enhance your understanding of water systems in terms of design, construction, commissioning, maintenance, and operations to ensure compliance with International Standards Organization (ISO) Criteria, Food and Drug Administration (FDA) Regulations and Guidance, United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopoeia (JP), Clinical and Laboratory Standards Institute (CLSI), the American Society for Testing and Materials (ASTM), Good Engineering Practice and others.
Classification of Water Purification Systems
Governing Regulatory Agencies
System Design Parameters
Distribution System Components
Recap, Questions and Answers
Commissioning and Qualification
Operations and Maintenance
Control and Monitoring System Performance
Upon completion of this course, each participant will have a comprehensive overview and understanding of water systems and how they are selected, installed, commissioned, validated, operated, and maintained in a regulated environment. The course content will enable the participant to understand system design, analyze performance data, ask more informed questions, and challenge findings when communicating in a group setting on a broad variety of water issues. In addition, the regulatory agencies with a direct impact on the design and operation of both compendial and non-compendial systems will be presented.
"The course director was excellent. Not only did he display the knowledge to properly guide and teach the course, but his pace in presenting the materials was excellent. I never felt that the material was presented too fast or too slow. He was always open to questions and encouraged them which was fantastic because that engagement increased my understanding of the material." Shervin G., Regulatory Compliance Manager, Thermo Fisher
"The Course Director was awesome. The humor that he added was nice, and his knowledge of the subject made this course easier to understand, as there is a lot of information." Kevin S., Operations Manager, Illumination Technologies
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process.
Accounts are a new feature on our website. Creating an Account helps you view your order history and manage your training programs.
If you are registering for others, please set up an Account in the Attendee’s name. If you are
registering more than one person, you’ll need to set up a separate account for each Attendee.
*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
Learn more »
Keep up to date with the latest news from CfPIE, including upcoming courses and events.
Members of participating industry organizations receive special discounts for all our training courses.
© 2001 - 2017 CfPIE, Inc. All Rights Reserved.