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ISPE to Focus on ICH Quality Standards at 2011 Washington Conference

Seven sessions, three training courses will help participants deliver cost-effective GMP solutions

Published: Wednesday, May 11, 2011 - 11:22

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global, nonprofit association of more than 22,000 professionals, will feature seven educational sessions, including two sessions focusing on the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) quality standards, as part of its 2011 Washington Conference, which will take place June 6–9, 2011, at the J.W. Marriott in Washington, D.C.

The ICH Q8, Q9, and Q10 guidelines will be a primary focus of Addressing ICH—Robust Process Validation and Compliance Assurance Starts with Product Realization: Effectively Applying Quality by Design (PQLI), a fundamental-to-intermediate-level session that will take place June 6–7. This session will highlight the business value of applying quality by design (QbD) principles and the risks that occur when QbD is not in place. The session will also help participants use related ISPE Good Practice Guides to implement QbD in their companies.

Sponsored by the ISPE Product Quality Lifecycle Implementation (PQLI) Committee, the session will be led by Roger Nosal, vice president of global chemistry, manufacturing and controls, Pfizer Inc. and Christopher Sinko, vice president, Bristol-Myers Squibb. It will feature presentations by a number of pharmaceutical-industry experts and prominent members of the PQLI committee.

Are You Ready for ICH Q11? Emerging Topics in the API Global Regulatory Environment will focus on the ICH Q11 guideline and will take place June 8–9. This intermediate-to-advanced session will feature industry and regulatory members of the ICH Q11 Expert Working Group who have written the guideline to provide background on the origins of Q11, the key concepts contained in the guideline, and the progress made toward harmonization.

The session, which will be led by Catherine Dubuisson-Brengel, assistant director, global regulatory affairs, Sanofi-Avantis and Jonathan Walker, director of manufacturing technology, Bristol-Myers Squibb. It will prepare participants to provide informed comments on the ICH Q11 guideline when it is published for public review, incorporate principles from the guidance into the development and life-cycle management of manufacturing processes for drug substances, and adopt a QbD submission to the Common Technical Document format.

Other educational sessions will include:
Barrier Isolation Technology Forum: Innovation, Updates, New Case Studies (20th Annual). This session presents developing technology and regulatory perspectives for barrier isolation, especially in regard to advanced aseptic processing, restricted access barrier systems (RABS), and isolators.
Commissioning and Qualification: Science and Risk-Based Approaches; Current Industry Experiences and New Guidance. Participants in this session will receive an overview and electronic copies of ISPE’s upcoming guidance documents, “ISPE Guide: A Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment,” and the “ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification” upon release.
GAMP Practical Application Case Study Workshops. This two-day session will present seven hands-on workshops and will introduce two newly-updated GAMP Good Practice Guides, “A Risk-Based Approach to Calibration Management, Second Edition,” and “A Risk-Based Approach to GxP Process Control Systems, Second Edition.” Participants will receive electronic copies of these documents.
Critical Utility Systems: Implementation of Risk and Cost-Based Strategies for Design, Operation, and Qualification. Delegates at this session will learn through real-life case studies about novel techniques and processes to optimize critical utility systems while controlling deliverables, installation, validation, and operational costs. The “ISPE Good Practice Guide: Process Gases” will be featured and an electronic copy will be provided to registrants upon release.
Implementing PAT in Manufacturing Environments: Case Studies from Development to Implementation. This one-day session will provide case studies from product development to regulatory submission highlighting the development of critical process parameters using a scientific approach and the use of Process Analytical Technology (PAT) solutions early in the process.

In addition to the educational content being presented, the 2011 Washington Conference will feature three training courses:
Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline Guide. This brand-new, two-day training course will include an overview of the ICH Q9 guideline and detail how the “ISPE Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)” uses the concepts of the guidance to create a scientific, risk-based method to help companies manage their risk of cross-contamination. Participants will receive a copy of the guide.
Complying with Part 11—Risk Management: Applying the GAMP Good Practice Guide Electronic Records and Signatures Principles. Using the “GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures” as a resource, this course will give participants a practical introduction to the 21 CFR Part 11 regulation, including up-to-the-minute updates on the current FDA review of the regulation. Participants will receive a copy of the guide.
HVAC for Pharmaceutical Facilities. This course will provide a detailed description of heating, ventilating, and air conditioning (HVAC) system fundamentals, including a discussion of primary system components such as fans, coils, humidifiers, and filters. Participants will receive a copy of the guide.

Complete session agendas and training-course outlines for the conference are available on the ISPE website. Register for the conference here, or call ISPE Member Services at (813) 960–2105.


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The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.