Washington Conference 2011 to focus on ICH quality standards.

ISPE May 16, 2011

Press Release Summary:

ISPE announced it will feature 7 educational sessions, including 2 focused on ICH quality standards, as part of its 2011 Washington Conference, which will take place June 6-9 in Washington, DC. Sessions will cover such topics as process validation, compliance assurance, and ICH Q11. In addition to educational content, conference will feature three training courses that address cross contamination risk management, 21 CFR Part 11 regulation compliance, and HVAC system fundamentals.

Original Press Release:

ISPE to Focus on ICH Quality Standards at 2011 Washington Conference

-Conference to consist of seven sessions, three training courses designed to help participants deliver cost-effective GMP solutions-

(TAMPA, FLORIDA, USA) - ISPE, a global, not-for-profit association of more than 22,000 professionals, announced today that it will feature seven educational sessions, including two sessions that will focus on ICH quality standards, as part of its 2011 Washington Conference, which will take place 6-9 June 2011 at the JW Marriott in Washington DC, USA.

ICH Q8, Q9, and Q10 will be a primary focus of Addressing ICH - Robust Process Validation and Compliance Assurance Starts with Product Realization: Effectively Applying Quality by Design (PQLIÂ®), a fundamental-to-intermediate level session which will take place 6-7 June. 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. This session will also help participants use related ISPE Good Practice Guides to implement QbD in their companies. Sponsored by the ISPE PQLI Committee, the session will be led by Roger Nosal, Vice President of Global Chemistry, Manufacturing & Controls, Pfizer Inc, USA and Christopher Sinko, Vice President, Bristol-Myers Squibb, USA, and 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 ICH Q11 and will take place on 8-9 June. This intermediate-to-advanced session will feature Industry and Regulatory members of the ICH Q11 Expert Working Group who have authored the guideline to provide background on the origins of Q11, the key concepts contained in the guideline, and the progress made towards harmonization. The session, which will be led by Catherine Dubuisson-Brengel, Assistant Director, Global Regulatory Affairs, Sanofi-Avantis, USA, and Jonathan Walker, Director Manufacturing Technology, Bristol-Myers Squibb, USA, 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 lifecycle 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 regards 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.

GAMPÂ® 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 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 BaselineÂ® Guide - This brand-new two-day training course will include an overview of ICH Q9 and detail how ISPE's Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Baseline Guide 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 GAMPÂ® Good Practice Guide Electronic Records and Signatures Principles - Using the GAMPÂ® 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 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 2011 Washington Conference are available on the ISPE Web site. To register for the conference, visit ISPE.org/2011WashingtonConference, or call ISPE Member Services at +1-813-960-2105. For press passes to attend this event, contact Danielle Hould, ISPE Communications Manager, by telephone at +1-813-960-2105 or via email at dhould@ispe.org.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is a Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is "Connecting a World of Pharmaceutical Knowledge" by providing Members with opportunities to develop their 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 opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.