January 7, 2011

4 Min Read
ISPE to Feature FDA Inspection Enforcement Trends Seminar at 2011 Tampa Conference

The International Society for Pharmaceutical Engineering (ISPE), a global, not-for-profit association of more than 22,000 professionals announced today that it will feature eight educational sessions, including a seminar designed to help pharmaceutical companies identify and address compliance risks prior to FDA inspection, as part of its 2011 Tampa Conference, which will take place February 21-24, 2011 at the Grand Hyatt Tampa Bay in Tampa, FL.

The FDA inspection enforcement trends seminar, titled, “Pharmaceutical Inspections and Compliance: Current FDA Enforcement Trends,” is a two-day event that will address dual FDA/industry presentations on the topics of enforcement, supply chain, and vendors/CMOs, GMP quality systems, Part 11, management responsibility, current inspections, continuous manufacturing, and process validation. The session will be led by FDA compliance officer Francis Godwin and Timothy Tyson, chairman and CEO of Aptuit Inc. USA, and will feature Sion Wyn, director of conformity, Ltd., UK and FDA consumer safety officers Brian Belz and Grace McNally as speakers.

Other educational sessions will include:

* Aseptic Processing of Sterile Products: Innovations, Regulatory Guidance and Compliance in a Practical World – This session will teach participants about the latest commercially-proven solutions in aseptic processing. Attendees of this seminar will also receive an electronic copy of the new ISPE Baseline® Guide: Sterile Manufacturing Facilities, tentatively scheduled for release during the first quarter of 2011.
* Quality Risk Management: Focused, Practical Application – Participants in this session will learn to build and implement a QRM strategy, apply tools and techniques to educate various teams and management levels to the QRM approach, explain how to document QRM to ensure its effectiveness, and adapt QRM applications that have worked for others.
* Data Integrity: How to Verify, Validate, and Maintain – This seminar will provide implementation examples which utilize GAMP® methodology in the design, testing, and implementation of different data warehouse repositories.
* Inspection Readiness Workshop: From Site Preparation to Successful Execution – This two-day interactive workshop will give attendees the tools to prepare their organizations for regulatory inspections, while allowing them to practice these skills in a safe and mentoring environment.
* Syringe Processing Workshop – The second annual syringe workshop will present new case studies, technology, and innovative ideas in clinical operations, high volume pharmaceuticals and biologicals for existing or new operations. Topics will cover all aspects of prefilled syringes from process and product development, packaging component issues, quality assurance considerations, and inspection hot topics.
* Containment: A Risk-Based Approach – This session will feature a discussion evaluating containment systems and approaches specifically for potent and highly hazardous compounds. As part of this seminar, the FDA will be invited to speak on how science and risk-based approaches to containment are viewed.
* Energy Saving Projects – Case Studies and Tools for Saving Energy – This seminar will present four case studies of energy improvement projects that have decreased the amount of utilities consumed resulting in lower production cost and increased energy intensity. Topics addressed will include water, steam, HVAC, electricity, process efficiency, funding, and rebates.

In addition to the educational content being presented, the 2011 Tampa Conference will feature three training courses:

* Cleaning Validation Principles – This course will cover elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.
* Containment Fundamentals – This course will focus on airborne contaminants and begin by discussing the definition, history, and rationale for the containment of compounds and processes.
* Process Validation in Biotechnology Manufacturing – This course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. This course also includes a pre-recorded online webinar that will allow participants to review fundamentals of the subject matter prior to the course.

Complete seminar agendas and training course outlines for the 2010 Tampa Conference are available on the ISPE Web site. To register for the conference, click here, or call ISPE Member Service at 813-960-2105.

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