Level: Intermediate to Advanced
ISPE CEUs: 1.3
Type: Classroom Training Course
|25 - 26 Jul 2016||Tampa, FL||USA||
Ms. Rebecca A. Brewer|
|17 - 18 Oct 2016||Boston, MA||USA||
Ms. Rebecca A. Brewer|
|12 - 13 Dec 2016||Tampa, FL||USA||
Ms. Rebecca A. Brewer
As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. With the FDA's risk-based regulatory initiatives focusing new attention on the risks of cross-contamination understanding lifecycle management techniques for an effective cleaning validation program is paramount. This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication. Additional content includes 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.
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 available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.
Double Your Education Opportunities in Process Validation
Monday, 27 Jun 2016 14.06
FDA Office of Pharmaceutical Quality Initiatives & 2016 Priorities
Friday, 24 Jun 2016 12.06
Interdisciplinary Perspectives on Key Pharma Industry Trends
Thursday, 23 Jun 2016 15.06