Level: Intermediate to Advanced
ISPE CEUs: 1.3
Type: Classroom Training Course
|20-21 May 2013||St. Louis, Missouri||USA||Rebecca Brewer|
|9-10 September 2013||Burlingame (San Francisco area), California||USA||Rebecca Brewer|
|7-8 October 2013||Prague||Czech Republic||Rob Walker|
|9-10 December 2013||Tampa, Florida||USA||Rebecca Brewer|
As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. FDA's risk-based regulatory initiatives focus new attention on the risks of cross-contamination. The solution is to understand life cycle management techniques for an effective cleaning validation program.
This course will cover elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. For mature cleaning validation programs, concepts such as understanding process control, capability, learning to effectively self-audit a cleaning validation program, and documentation will be essential takeaways.
This course contains knowledge related to the CPIP™ technical knowledge competency elements Facilities and Equipment: Design and Construction / Installation and Production Systems: Production Control. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.