Life Science Training Options - FDA Guidances & Standards

Training courses match up-to-date FDA and global compliance expertise to timely needs across pharma, biotech, and medical device specialties

Malvern, PA - January 30, 2013 - The Center for Professional Innovation and Education (CfPIE), the global leader in training for pharmaceutical, biotech, and medical device professionals, has updated its Website to make it easier for life sciences professionals to pinpoint training courses that can help them comply with the latest U.S. and global requirements, practices, and standards pertinent to their respective industries.

According to CfPIE founder and Managing Director, Mark Mazzie, "Each new course description on the streamlined www.cfpie.com site highlights course content, learning objectives, a list of job profiles that will benefit most, and participant feedback. This makes it easier for professionals across the spectrum of life-sciences disciplines and job functions to identify which of 350 class selections within our 71 course titles meet their specific training needs."

Course director Janet Gough, who conducts writing classes for CfPIE, draws on her own hands-on experience and keeps content updated with current industry best practices. Gough states, "In my Introduction to Effective Medical Writing offering, I address the standards for submissions to the agencies in accordance with binding regulations and the International Conference on Harmonization (ICH) guidelines, such as Guideline for Industry, Structure and Content of Clinical Study Reports, E3. I provide insight into SPIRIT and CONSORT guidelines as well. For submissions to professional journals and conferences, the course stresses adherence to the International Committee of Medical Journal (ICMJE) Uniform Requirements, and addresses the very current topic of avoiding accidental plagiarism."



Other recent FDA guidances that CfPIE training courses address include Electronic Source Documentation in Clinical Investigations, Acceptance and Filing Reviews for Premarket Approval Applications (PMAs), the Refuse to Accept Policy for 510(k)s, and Good Reprint Practices.