This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.
ICH guidelines provide sponsors of FDA regulated clinical trials with an excellent tool for compliance with FDA GCP regulations and for successfully hosting FDA inspections at clinical sites and at the sponsor. This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. Emphasis is placed on linking ICH guidance documents with FDA regulations in 21 CFR Parts 11, 50, 54, 56, 312, and 812 and understanding the key differences between guidance documents and regulations. Actual case studies from FDA Bioresearch Monitoring inspections are used to explain and clarify ICH guidelines and FDA regulations.
How to use ICH E6 to set up GCP quality systems for a specific clinical trial?
How to use the E6 Essential Documents section to prevent critical recordkeeping errors?
What are the most common violations found by FDA investigators at clinical sites?
What are the most common violations found by FDA investigators at clinical trial sponsors?
How to develop written procedures for 'each stage of data handling'?
What is the most common problem that causes FDA investigators to lengthen the amount of time spent on the inspection?
What new concern does FDA have with the conduct of clinical trials?
ICH guidelines provide sponsors of FDA regulated clinical trials with an excellent tool for compliance with FDA GCP regulations and for successfully hosting FDA inspections at clinical sites and at the sponsor. This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. Emphasis is placed on linking ICH guidance documents with FDA regulations in 21 CFR Parts 11, 50, 54, 56, 312, and 812 and understanding the key differences between guidance documents and regulations. Actual case studies from FDA Bioresearch Monitoring inspections are used to explain and clarify ICH guidelines and FDA regulations.
Areas Covered in the seminar:
What are the top FDA concerns in a GCP Inspection?How to use ICH E6 to set up GCP quality systems for a specific clinical trial?
How to use the E6 Essential Documents section to prevent critical recordkeeping errors?
What are the most common violations found by FDA investigators at clinical sites?
What are the most common violations found by FDA investigators at clinical trial sponsors?
How to develop written procedures for 'each stage of data handling'?
What is the most common problem that causes FDA investigators to lengthen the amount of time spent on the inspection?
What new concern does FDA have with the conduct of clinical trials?
Who Will Benefit:
This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials for pharmaceutical, medical device, biotechnology, and biologics products.- Clinical Development managers and personnel
- Clinical research associates
- Quality assurance managers and auditors
- Clinical Development managers and personnel
- Consultants
- Regulatory Affairs Specialists
Course Provider
Carl Anderson,
