This webinar on clinical trial audit/inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.
Your position, as a clinical research professional, has an important role in your organization’s preparation for and success at audits/inspections, and it is your responsibility to know how to ensure your organization’s readiness for an audit/inspection at all times.
This training will teach you how to prepare for an audit or inspection and how to act and respond to questions during the audit or inspection. We will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how to ensure the conduct of the clinical research at the investigative site(s) complies with them. By attending this training you will be able to appropriately act upon the audit or inspection findings - to correct current misconduct and prevent future recurrence.
After completion of this training not only will you prepare your organization for audits/inspections but also ensure they are successful.
Why Should You Attend:
Significant audit/inspection findings expose you and your organization to regulatory or contractual sanctions, including but not limited to - discontinuation, disqualification, seizure, injunction and/or civil money penalties.Your position, as a clinical research professional, has an important role in your organization’s preparation for and success at audits/inspections, and it is your responsibility to know how to ensure your organization’s readiness for an audit/inspection at all times.
This training will teach you how to prepare for an audit or inspection and how to act and respond to questions during the audit or inspection. We will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how to ensure the conduct of the clinical research at the investigative site(s) complies with them. By attending this training you will be able to appropriately act upon the audit or inspection findings - to correct current misconduct and prevent future recurrence.
After completion of this training not only will you prepare your organization for audits/inspections but also ensure they are successful.
Learning Objectives:
- Understand what Audits/Inspections are all about.
- Obtain tools and techniques for a planned Audit/Inspection preparation.
- Learn the DOs and DON'Ts prior to and during an Audit or Inspection.
- Understand what actions are required following an Audit/Inspection.
- Obtain tools and techniques to ensure Audit/Inspection preparedness is maintained at all times.
Areas Covered in the Seminar:
- Audits and Inspections: Definitions, Goals, Causes and Procedures.
- Clinical Site Audits/Inspections findings and FDA warning letters.
- Responsibilities of the sponsor, CRO, Investigational site/Investigator.
- Preparation for a planned Audit/Inspection - tools and techniques.
- Appropriate conduct during the Audit/Inspection.
- Completion and follow up after the Audit/inspection.
- DOs and DON'Ts prior to, during and after an Audit/Inspection.
- Implementation of corrective action plan - tools and techniques.
- Ensuring continuous Audit/Inspection preparedness - tools and techniques.
Who Will Benefit:
This webinar will provide valuable assistance to the following Clinical Research Personnel in the Pharma, Biotech and Medical Device industries:- Sponsor/CRO/Investigative sites General Managers and Directors
- Principal Investigators
- Site Coordinators
- Project Managers
- Clinical Team Managers/Leaders
- Clinical Research Associates/Monitors
- Project Assistants
- Clinical Research Trainers
- Quality Assurance personnel
- Regulatory Compliance Associates and Managers
Course Provider
Ornat katzir,
