Event to explore lessons learned from FDA 483s in tracks focused on Biotech, Oral Solid Dosage Processing and Containment, and Process Validation
TAMPA, Fla., Feb. 8, 2012 /PRNewswire-USNewswire/ -- ISPE announced today that the US FDA's Grace McNally will appear at the Society's upcoming Lessons from 483s: Enhancing Efficiency, Quality and cGMP Compliance Conference. McNally will add her expertise to that of other industry and regulatory experts at the two-day event, which will review recent regulatory citations (FDA-483s) and provide guidance on how the citations can be avoided. This conference will give pharmaceutical professionals the vital insights into regulatory issues they need in order to avoid the costly and damaging consequences that can result from 483 citations, such as recalls and plant shutdowns.
Educational content will address 483s in the context of biotech, oral solid dosage processing and containment, and process validation. The conference, part of ISPE's Facilities of the Future conference series, will take place in Tampa, Florida USA on 27 – 28 February 2012.
"As the technical voice of manufacturing and engineering in the pharmaceutical industry, ISPE is committed to presenting programs that facilitate relevant dialogue and the sharing of best practices among industry leaders, manufacturing experts and leading regulators," said ISPE's new President and CEO Nancy Berg. "At a time when manufacturing operations are under tremendous pressures to improve effectiveness, deliver quality and reduce costs, ISPE is responding with new programs and conference formats that feature dynamic and focused session content. Our events are developed to deliver information, discussion and networking that lead to new ideas, problem-solving and process improvement concepts that, when applied, have positive bottom-line results."
For more information on this conference, including detailed agendas and registration information, visit www.ISPE.org/FacilitiesConference.
ISPE will also hold a related training course immediately following this conference. The course, titled "Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline® Guide" will be held 29 February – 1 March 2012 at the same venue. More information on this training course can be found at www.ISPE.org/2012-Tampa-Training.