Risk-MaPP provides a scientific risk-based approach, based on ICH Q9, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety.

Opportunities to understand the “why”, “what”, and “how to use” the Guide include conferences, webinars, training, and white papers. Educational sessions pertaining to Risk-MaPP, offered during a series of conferences led by the Guide authors, will focus on use of the logic diagram, how health based limits are developed, setting cleaning validation limits, risk assessments for cross contamination, and formulating a Quality Risk Management Plan as part of a Quality System. Attendees will hear directly from companies that have implemented Risk-MaPP principals in several case studies.

Upcoming Events:

• Live Webinar: “Risk-MaPP: What is It and Why You Need It!,” 14 September 2010
• ISPE Brussels Conference session: 20-21 September – Global Guide Launch (attendees receive complimentary copy of document with paid registration)
• ISPE Risk-MaPP Conference: 4-5 October
• Japan Risk-MaPP Conference: 21-22 October
• Singapore Risk-MaPP Conference: 25-26 October
• ISPE 2010 Annual Meeting : 7-10 November, Orlando, FL, USA
• Guidance Document: ISPE Baseline^® Guide, Risk Based Manufacturing of Pharmaceutical Product (Risk-MaPP), A Guide to Managing the Risks Associated with Cross Contamination (Anticipated 3Q 2010)
• Knowledge Brief: Risk-Based Approaches to Cross Contamination

Visit www.ISPE.org/Risk-MaPP for more information on Risk-MaPP

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The ISPE Brussels Conference will be the global launch of the Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP). Attendees will receive a complimentary copy of the Guide with paid registration.  In preparation for the Risk-MaPP Seminar, it is encouraged that delegates attend a Live Webinar ‘Risk-MaPP: What it is and Why You Need it!’ on 14 September 2010.

Risk-MaPP provides a scientific risk-based approach, based on ICH Q9, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. If you are involved with multi-product facilities, this document is an essential tool in understanding and control the risk of cross contamination, while also protecting the operator.

The conference will provide industry professionals the opportunity to learn from leaders and innovators from across the globe.  The conference seminars and training courses include:

Conference Seminars

• Barrier Isolation Technology Forum: Innovation, Updates, New Case Studies
• Dedicated Facilities, Cross Contamination and the Risk-MaPP Approach
• GAMP: A Guided Tour of the World of Good Practice Guides
• PQLI: Case Studies in QbD for Biotechnology and Small Molecule Product Realisation
• Containment: The Devil is in the Detail
• Investigational Products (IP): Lean and Compliant Applying Efficient Tools to a Regulated Clinical Supply Chain
• Science and Risk-Based Commissioning and Qualification (C&Q): Transitioning and Transforming

Training Courses

• Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation
• Practical Application of Computerised Systems Compliance GAMP® 5 (includes online course)

In addition, the event will include sponsorship and tabletop exhibits of the industry’s top suppliers of pharmaceutical manufacturing, and networking events for pharmaceutical industry professionals. 

For complete conference seminar and training course information, or to register for the ISPE 2010 Brussels Conference, visit http://www.ispe.org/cs/2010_brussels_conference/conference_programme, or call ISPE Members Services at +32 2 743 44 22. For sponsorship and tabletop exhibit information, contact Elmarie Herloff-Petersen, by tel: +32 2 789 2337 or email Elmarie.Herloff-Petersen@mic-group.com. 

For press passes to attend this event, contact Ryan Smith, ISPE Communications Manager, by tel: +1-813-960-2105, or email rsmith@ispe.org.

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Worldwide Training to be held in Washington, D.C. USA

The International Harmonization Group (ICH) Quality Implementation Working Group (Q-IWG) presents “Integrated Implementation Training Workshop for ICH Q8, Q9 & Q10” in Washington, D.C., USA, 6 – 8 October 2010.

The Integrated Implementation Training Workshop for ICH Q8, Q9, and Q10 is the second in a series of three worldwide training workshops that will provide practical training on integrated implementation of Q8, Q9, and Q10 in pharmaceutical development, manufacturing, regulatory assessment, scale up to commercial operation, and GMP-inspection.  A third training workshop will be held in Tokyo, Japan from 25-27 October.

“On behalf of the ICH Quality Implementation Working Group, you are invited to attend a special training opportunity regarding the future of pharmaceutical development, manufacturing and quality,” said Jean-Louis Robert, Rapporteur of the ICH Q-IWG and Chairman of the Faculty.  “This workshop will provide comprehensive training on the integrated implementation of ICH Guidelines Q8, Q9, and Q10, and how they apply to drug (medicinal) products and related operations.”

6 – 8 October 2010
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
Bethesda, Maryland USA 20852
Tel: +1-301-822-9200

For more information or to register for the Washington Workshop, visit http://www.ispe.org/2010ICHWorkshops. 

The ICH Workshops are co-sponsored by ISPE and PDA.

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Call for Hot Topics
Due 30 June 2010

Do you have a hot topic for a session at Annual Meeting? Several time slots have been saved for late breaking ideas. Submit yours by downloading the Call for Proposals form ( 43 KB) and submit to gphillips@ISPE.org with the subject line Hot Topic Proposal.

Call for Poster Presentations
Due 30 June 2010

What is a Poster Presentation?
Posters present information pictorially and with written documentation. They are an effective means of sharing a new application or approach, a creative solution, or a collaboration that worked.

Eligibility
Professionals from the pharmaceutical, biotechnology or medical device industry, and university faculty and graduate students submit abstracts for review. Abstracts are reviewed for sound technical content and avoidance of commercial intent. Submissions will be accepted from any ISPE Member or professional in the pharmaceutical industry or academia.

Review Criteria
Technical relevance, merit, organization, clarity, and avoidance of commercial intent.

How to Submit and More Information
Download the Poster Proposal form ( 38 KB)

Posters are featured at the Tuesday afternoon and Wednesday morning break times.

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Discovering What’s Next: Reality, Retooling, Growth

Registration for the ISPE 2010 Annual Meeting in Orlando is now open.  Location and preliminary seminar information is already posted and will be updated regularly. 

Annual Meeting features education sessions, keynote addresses, poster presentations, networking opportunities, hot topic sessions, and more. Don’t miss THE event of 2010!

Call For Hot Topics
Do you have a hot topic for a session at Annual Meeting? Time slots are available for late breaking ideas; download the form and then email Ginger Phillips, gphillips@ISPE.org with the subject line “Hot Topic Proposal” by 30 June 2010.

Call For Poster Presentations
Share a new application or approach, a creative solution, or a collaboration that worked by participating in the Poster Presentation at Annual Meeting .  Posters are due by 30 June 2010.

Education Sessions will be featured in each of the following Tracks

•Facilities and Equipment
•Outsourcing
•Retooling for Operational Excellence
•Successful Delivery
•Regulatory
•Young Professionals
•Information Systems
•Hot Topics
•Sustainability
•Project Management
•Investigational Products

Preview. Post. Particpate.

•Regularly visit the ISPE Blog at ISPE.org/blog
•Follow the ISPE Twitter page at twitter.com/ISPEorg #ISPEAM10
•Networking with colleagues at LinkedIn.com/companies/ispe
•Networking with colleagues at Facebook.com/ISPEorg

For more information or to register, visit http://www.ispe.org/2010annualmeeting.

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