Aseptic Processing of Sterile Products: Innovations, Regulatory Guidance and Compliance in a Practical World (E01)
| 21-22 February CEUs: 1.2  |
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Planned and Implemented by the ISPE Sterile Products Processing Community of Practice (COP)
Attend this two-day seminar to learn about the latest commercially proven solutions in aseptic processing which you can apply.
- Get updates on hot regulatory topics
- Learn from experts working in similar environments to yours
- Participate in in-depth case study presentations and discussions
- Network with attendees and presenters
Topics will cover a range of technologies for sterile products, from compounding to inspection and include:
- Sterile filtration
- New filling equipment
- Contract manufacturing capabilities
- Lyophilization technology challenges
- Visual inspection technologies
- Recent warning letters / regulatory updates
- Case studies
This session will also feature the new ISPE Baseline® Guide: Sterile Manufacturing Facilities*.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Describe what is happening in the world of sterile technologies
- Evaluate warning letter implications for their business
- Apply learning from others through case study
- Explain recent regulatory trends
- Expand your industry network
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
This Session relates to the following Communities of Practice (COPs)
Sterile Products Processing
Related Guidance Documents, Articles, and Publications
- NEW - ISPE Baseline® Guide: Sterile Manufacturing Facilities*
- Recent Warning Letters
Visit www.ISPE.org/Publications for more information
*Anticipated release date Q1 2011. Date is subject to change. This seminar is priced to include an electronic copy of the guide.