Cost-effective auditing: Making the most of the time on-site
Thursday, February 20, 2014 from 10:00 AM to 11:00 AM (PST)
This training on clinical audit will teach attendees how to prepare for audit and ensure readiness at all times.
Why Should You Attend:
How effective are your clinical trial audits? Can you rapidly identify major issues that could negatively impact your ability to manufacture products? Audits can be challenging – there can be an adversarial undercurrent even before it starts. And rightfully so – there can be a lot on the line, such as continued business relationships and continued revenue streams. When to start an audit program is always a concern, especially in the early stages of product development – whether it is performed on the premises or off-site.
By attending this webinar, the participants will learn how to prepare for a clinical trial audit so that one can maximize time and information gathering time during the audit. It will teach the attendees to manage the audit if participants show defensive attributes. Learn how to “pull the thread” and find out if what you see is reality.
Assessing the significance of a finding, in the context of the operation and how to effectively communicate the concern can be challenging – be prepared to adjudicate the significance of each finding at the wrap-up meeting.
Areas Covered in the Webinar:
- How to prepare for the audit
- To use a checklist or not – that is a question
- The tour
- Records: how to select and how to review
- Procedures and quality systems – maximizing everyone’s time
- Avoiding common pitfalls
- The wrap-up
- The Report
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
- Healthcare providers interested in exploring the field of Clinical Research
- New Clinical Research Coordinators (1-2 years)
- New Principal Investigators
- Administrative managers in charge of Clinical Research
- Regulatory Compliance Associates and Managers
Janet Rose Rea, is a consultant for the biopharmaceutical industry and the principal in her company, QARA Services, LLC. Ms. Rea was also a faculty member at the U of W, providing a current industry perspective in the BioMedical Regulatory Affairs, where she had been a frequent lecturer since 1999. She held the position of Vice President, Regulatory Affairs and Quality at Poniard Pharmaceuticals (previously NeoRx), from 2008 – 2010 and AVI BioPharma from 2003 – 2008. She was also a corporate officer for both organizations.
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.