Active Pharmaceutical Ingredient (API) and Drug Product Specifications
November 18 - 19, 2014 - Malvern PA USCenter for Professional Innovation and Education, Inc.
info@cfpie.com
Phone:(610) 688-1708
One common Sponsor regulatory inspection finding is inadequate monitoring. When an internal audit or regulatory inspection occurs, the first thing that is requested is all written documentation. The adequacy or inadequacy of monitoring can be demonstrated and assessed in a number of ways but one manner where this occurs is through review of written monitoring communication. While communication can be both verbal and written, written documentation is of greater concern as it forever documents actual or potential issues for all to see and from which they draw conclusions. Poorly communicated goals, assessments and results can reflect poorly on a clinical study. In addition written communication is the basis for planning current and future actions and can impact policies, procedures, and overall project conduct. Poor communication can result in misinterpretation, need for re-work and a loss of productivity at both the sponsor and site level. Among other skills, excellent communication can help lead to excellence within the project itself. This course will provide direction on what excellent communication skills entail and how it results in quality work when combined with good documentation practices. It will demonstrate what is needed to produce effective written communication in support of a clinical trial. It will provide practical advice on effective writing skills, good documentation practices and how these relate to inspection/audit findings. Practical examples and exercises, e.g., developing and writing effective monitoring reports, will be performed by the participants to guide them on producing concise, clear written communication as it pertains to monitoring efforts. In addition it will demonstrate how management can use written communication to assess monitoring activities. The session is geared towards introductory and intermediate participants at the sponsor level who are interested in developing their written communication skills.