12 June 2012 -- The Regulatory Affairs Professionals Society (RAPS) will host a webcast tomorrow, 13 June, at 12:00 pm EDT, addressing how regulated life science companies can produce effective Standard Operating Procedures (SOPs).
Well-written SOPs provide the foundation for good operations. Almost every deficiency identified in 483s and Warning Letters from the US Food and Drug Administration (FDA) can be traced back to shortcomings with SOPs. This RAPS webcast, How to Write SOPs: Tips on Writing the Perfect Document to Impress FDA, covers various aspects of SOPs, with case studies and examples to highlight common errors and potential solutions. Mukesh Kumar, PhD, RAC, senior director, Amarex Clinical Research, and Sally Breisch, chief operations officer and medical writer, Amarex Clinical Research, will lead this session.
• Mukesh Kumar, PhD, RAC, senior director, Amarex Clinical Research
• Sally Breisch, chief operations officer and medical writer, Amarex Clinical Research
90-minute webcast entitled How to Write SOPs: Tips on Writing the Perfect Document to Impress FDA
13 June, 12:00–1:30 pm EDT
How to Access:
Members of the working media may request access to this live RAPS webcast or to the recording by contacting Zachary Brousseau, senior manager, communications, RAPS, at firstname.lastname@example.org or +1 301 770 2920, ext. 245.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org