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FDA Compliance

Event: Pharmaceutical Inspections and Compliance

Feb. 21–24 in Tampa, Florida

Published: Monday, January 10, 2011 - 10:42

(ISPE: Tampa, FL) -- As part of its 2011 conference, “Applying Solutions to Emerging Industry Challenges,” the International Society for Pharmaceutical Engineering (ISPE), a global, nonprofit association of more than 22,000 professionals, will feature eight educational sessions designed to help pharmaceutical companies identify and address compliance risks prior to FDA inspection. The conference will take place Feb. 21–24 at the Grand Hyatt Tampa Bay in Tampa, Florida.

The FDA inspection enforcement trends seminar, “Pharmaceutical Inspections and Compliance: Current FDA Enforcement Trends,” is a two-day event that will address FDA and industry presentations on enforcement, supply chain and vendors, good manufacturing practices (GMP) from 21 CFR Part 11, management responsibility, current inspections, continuous manufacturing, and process validation. The session will be led by Francis Godwin, a compliance officer with the Food and Drug Administration (FDA), and Timothy Tyson, chairman and CEO of Aptuit Inc.

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 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 (QRM): Focused, Practical Application. Participants will learn to build and implement a QRM strategy, apply tools and techniques to educate various teams and management levels about 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 use good automated manufacturing practices (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 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; heating, ventilation, and air conditioning (HVAC); electricity; process efficiency; funding; and rebates.

In addition to the educational content 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 determining residues to be targeted, selecting analytical and sampling methods, determining appropriate limits in various pharmaceutical and biotechnology processes, and establishing 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. The course also includes a prerecorded online webinar that will allow participants to review fundamentals of the subject matter prior to the course.

Complete seminar agendas and training course outlines, and registration for the conference are available at www.ISPE.org/2011TampaConference. For press passes to attend this event, e-mail Danielle Hould, ISPE communications manager, at dhould@ispe.org.  


About The Author

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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.