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Clinical Active
Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancePanel
Overview: In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).
Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).
Areas Covered In the Seminar:
- Discuss how QA differs from QC and who is responsible for each
- Determine who gets audited and factors and metrics for assessing when or why to audit
- Discuss guidelines on how the FDA trains its investigators to audit Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs)
- Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs
Who will benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including:
- Clinical Quality Assurance Auditors
- Clinical Quality and Compliance Professionals
- Clinical Research Associates (CRAs)
- Project Managers
- Medical Monitors
- Regulatory Affairs Professionals
- Clinical Research Coordinators (CRCs)
- Clinical Investigators (PIs)
- IRB Administrators and Members
Overview
: In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).
Why you should attend
: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).
Areas Covered In the Seminar:
- Discuss how QA differs from QC and who is responsible for each
- Determine who gets audited and factors and metrics for assessing when or why to audit
- Discuss guidelines on how the FDA trains its investigators to audit Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs)
- Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs
Who will benefit:
This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including:
- Clinical Quality Assurance Auditors
- Clinical Quality and Compliance Professionals
- Clinical Research Associates (CRAs)
- Project Managers
- Medical Monitors
- Regulatory Affairs Professionals
- Clinical Research Coordinators (CRCs)
- Clinical Investigators (PIs)
- IRB Administrators and Members
About the Author
Sandy is currently the co-founder and Chief Clinical Officer of Research Alliance LLC.; a consulting firm focused on global clinical trial solutions, tools, and training to streamline drug development to market. The firm advises clinical research sites, pharmaceutical drug development, biotech, medical device, and contract support organizations. Sandy began her journey in Clinical Research over 13 years ago. Her experience spans key aspects in multiple therapeutic areas and phases of drug development in the roles of study coordinator, site monitor, clinical research project manager, and trainer. She has effectively provided clinical research education and customized training in areas of the clinical research process, the FDA regulations, GCP (Good Clinical Practice) and the International Conference of Harmonization (ICH) guidelines. Sandy has created company-wide SOPs for a variety of relevant processes related to clinical research including, but not limited to, Informed Consent Process, Scheduling, Follow-up, Adverse Effect Reporting, etc. She has also been pivotal in coordinating, arranging, and managing the infrastructure of the company policies and procedures. She has also been awarded the National Association of Women Business Owners – NYC Chapter Phoenix Award 2008 and the National Association of Women Business Owners – NYC Chapter Golden Glove Award 2008.
Is it possible for a medical officer to get a Ph.D. on active duty?
I am working on a bachelors in clinical laboratory science and am considering going in as a medical lab officer. I would like to eventually get a Ph.D. Is it possible while on active duty? I am considering all three branches so far for commissioning and will go with whoever picks me up first.
Yes, it is entirely possible. Graduate education in a normal part of an officer's assignment pattern, and clinical degrees would be the normal pattern for Medical Service Corps officers. Many of my friends who are line officers or combat arms officers have at least two Master's degrees and in couple cases a PhD as well by the time they retired at 30 years. One of my Naval Academy classmates had two Masters', an MD and a PhD in public health before we had hit 20 years; not surprisingly, on top of all of that he was picked to be an astronaut.
Intero to Clinical Pharmacy pharmacotherapy --- www.active-eg.org
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