ISPE Brussels Conference 2010 on Risk-based control strategies in pharmaceutical industry
by Madjackfrost on July 14, 2010
Do you want to further your career? By attending the ISPE Brussels Conference seminars you can obtain the knowledge, skills and professional contacts you need.
Save up to 300 Euros with the early bird fees until 13 August 2010.
Conference Seminars:- Barrier Isolation Technology: Innovation, updates, and new case studies
- GAMP® Good Practice Guides: roundtable, best practices, and case studies
- Risk-MaPP: ISPE’s new Risk- MaPP Baseline® Guide. FREE COPY of the new Risk-MaPP Guide. Upon registration to the Seminar, a copy of the guide will be sent to you (after anticipated publication date during third quarter 2010).
Basic and background information will be provided via webinar prior to the Brussels Conference so that more time can be spent on workshops and case studies (Webinar is not included in session fee, but is highly recommended for maximum understanding). How you will benefit at the conclusion of this webinar:
• What Risk-MaPP is
• The history of Risk-MaPP
• Why Risk-MaPP is important for multi-product facilities
• Why Risk-MaPP is needed
• How Risk-MaPP fits into the regulatory landscape
- PQLI® case studies in Quality by Design for Biotechnology and Small Molecule Product Realisation
- Containment and Cross-Contamination: understand new technologies, share best practices, identify and understand critical areas
- Investigational Products (IP): workshops, development of best practice solutions and understanding the issues on IP.
- Science and Risk-based Commissioning and Qualification: understand regulatory perspectives and how to apply risk-based principles within your organisation through case studies and workshops
Training Courses: - Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation. Review the regulatory philosophy, aseptic process and equipment considerations, clean room design and operation, differential pressure requirements, airlocks, basic utility systems, European HVAC considerations, basic commissioning and qualification issues, and a brief introduction to barrier isolation technology.
- Practical Application of Computerised Systems Compliance Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerised Systems. Solve computerised systems compliance challenges using GAMP 5 case studies at this highly interactive course to understand GxP Risk; develop supplier assessments; specification / verification approaches; strategies; validation plans; high-quality test scripts, and review regulatory hot topics.
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| Sponsorship and Table Top Opportunities ISPE offers your company exclusive sponsorship opportunities in 2010 to enhance your corporate image and build your brand awareness. Don’t miss this opportunity to raise the visibility of your company! For information on ISPE sponsorship opportunities contact Elmarie Herloff-Petersen, tel: +32 2 789 2337 |
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