Course Description:
Pharmaceutical water systems must be appropriately designed, operated, and maintained in order to produce high quality water. USP General Chapter <1231> Water for Pharmaceutical Purposes provides detailed information about nearly every aspect of maintaining, validating, and monitoring a pharmaceutical water system. Validation is the process to demonstrate that the design and operation of a pharmaceutical water system consistently produces water that meets USP requirements. General Chapter <1231> provides extensive discussion of the life cycle elements to maintain a validated state of control. This webinar specifically addresses validation and qualification approaches, including design and operation, water sampling purposes and procedures, the “trigger levels” associated with test results, and microbial identification. Other elements of USP Chapter <1231> will be discussed in future webinars. The instructor, Mr. Rosty Slabicky has been involved in developing the contemporary pharmaceutical water standards and associated with USP for over 25 years as an advisor and USP Pharmaceutical Waters expert during three consecutive cycles as a volunteer.
The live version of this webinar took place on December 1, 2015. Includes English subtitles.
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Upon
completion of this course, you will be able to::
- Understand the elements to validate water systems
- Compare the regulatory requirements for validation including FDA and the new EU GMP Guidelines Annex 15
- Qualification and Validation
- Develop a sample plan for validation, process control, and quality control
- Identify the ongoing activities needed to maintain a validated state of control
Who should participate:
- Water system engineers, owners, and users
- Production managers
- Analytical chemists and microbiologists
- Chemistry and microbiology lab managers
- Validation managers
- QA/QC managers
- Compliance managers
- Regulatory affairs specialists