FDA GCP Audits Ensuring Compliance for Drug, Device and Biologic Studies
Product Details
Clinical investigators, monitors, CROs, sponsors and IRBs are continually faced with the overwhelming challenge of preparing for audits. To secure compliance, it is critical to know not only what to anticipate but also how to host an audit and how to respond when audited. More importantly, maintaining a state of audit-readiness throughout the scope of each clinical study is imperative. Learn from a renowned former FDA employee and compliance expert who will empower you to ensure a successful audit every time.
If you are involved in drugs, devices or biologics, you will benefit from this course.
This interactive workshop will teach you to:
- Assess your compliance level
- Examine your role in securing compliance in relation to the roles of others within your clinical research community
- Determine how to avoid data quality and integrity problems during a study
- Improve your SOPs to assure compliance
- Maintain a state of audit-readiness
- Recognize the proper response to audit findings
Even if you've attended other training workshops, you won't want to miss FDA GCP Audits — Ensuring Compliance for Drug, Device and Biologic Studies. Why?
Because during this two-day intensive workshop of learning, you will:
- Participate in a complete mock audit
- Acquire a solid foundation of FDA GCP compliance principles
- Explore new FDA regulatory and policy initiatives, including Part 11 compliance
- Identify the most-commonly encountered compliance issues
- Review actual case studies
- Examine the most effective ways to review protocols, monitoring and data retrieval
- Utilize forms and checklists to evaluate your organization's current state of compliance
- Get straightforward answers from a former FDA official
- Learn how to detect and prevent fraud and misconduct
- Receive numerous guidelines, informational sheets, sample FDA forms and letters, checklists and other valuable resources to help you ensure compliance
Given the ever-evolving regulatory and research environment, this workshop is a must. Noncompliance is costly and can put studies, products and business relationships in jeopardy.
Why wait when you can build future success — and status — into your clinical research site today!