Aseptic Processing of Sterile Products: Innovations, Regulatory Guidance and Compliance in a Practical World (E01)
| 22-23 February CEUs: 1.2 |
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 Current as of 21 January 2010 |
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Attend this two-day seminar to learn about the latest commercially proven solutions in aseptic processing. Learn from experts working in similar environments to yours, participate in in-depth case study presentations and discussions, and network with attendees and presenters. Topics will cover a range of technologies for sterile products, from compounding to inspection, and include:
- Inspection perspectives with respect to regulatory and industry guidance
- Meeting Annex 1 capping requirements
- Aseptic fill/finish processing
- The “c” in cGMPs?
- Risk-assessment
- Trends in advanced aseptic processing: isolators and RABS
- X-Ray for inspection of opaque and freeze dried products
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Understand different approaches to compliance with EU Annex 1 in regards to capping environmental requirements
- Understand and effectively apply new developments in product inspection
- Contrast and analyze alternative approaches to fill/finish operations
- Apply new technologies in aseptic manufacturing
Who Should Attend
Professionals from engineering, operations, quality, planning and project management
Leaders
Speakers
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom
Communities of Practice (COPs)
Sterile Products Processing
CPIP™ Knowledge Element
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This Webinar relates to the following CPIP™ Knowledge Element: |
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Related Technical Documents, Articles, and Publications
ISPE Baseline® Guide: Volume 3 - Sterile Manufacturing Facilities
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.