Despite well-written standard operating procedures, impeccable training records, and up-to-date quality control practices, many departments will still experience adverse audit findings. These findings can dramatically affect the priorities of a department as rapid action must be taken to secure permanent resolution to issues found by external or internal audits. As a recipient of an audit report, you have the opportunity to respond to the audit findings prior to issuance of the final report. In the response, you will need to explain how report findings will be resolved and include an implementation timetable. The effort to address these findings can be lengthy and frustrating. The overarching cause for delays in addressing audit recommendations and observations can be traced to a lack of clear response and accountability for follow up, compounded by lack of clear understanding on reporting obligations.

This presentation will focus on ways to reduce any confrontation and/or delays in responding to audit recommendations and observations through the use of a structured response framework known as A-STAT© (Assuage-Specific, Trackable, Accountable, Time-Bound).

This audio conference covers:

• The origins and intent of the audit, and the role of both auditor and auditee
• How to effectively address errors in interpretation of audit findings
• Strategies to reduce potential confrontations/bias in audit responses
• Writing objective and logical responses to audit findings
• Planning for future audits

About the speaker:

Thomas J Purcell, MSPM, a freelance medical writer with 25 years of experience in writing, editing, and proofreading a wide variety of clinical and regulatory documents. He understands the importance of accurate medical writing as a critical component to the clinical development process. He has used his pharmaceutical writing experience to present at both national and local meetings in the biopharmaceutical industry. Thomas has authored several articles, which appear in the Drug Information and American Medical Writers Association (AMWA) Journals. Thomas received a Masters of Science degree in Project Management from the George Washington University, District of Columbia. Thomas also holds a Master of Science degree in Technical Communication from Rensselaer Polytechnic Institute, Troy, New York.

Who should attend?

• Clinical Directors
• Clinical Managers
• Directors of Regulatory Affairs
• Managers of Regulatory Affairs
• Directors of Quality Affairs
• Managers of Quality Affairs