Webinar On Good Documentation Practices for Clinical Trials

Description :

This webinar is intended to help you adequately implement Good Clinical Practices (GCP): in particular, documentation requirements during clinical trials for both drugs and medical devices.

To adequately implement GCPs, there are a set of standard operating procedures (SOPs) to be established and maintained at any given facility, to the extent applicable, as a sponsor, clinical investigators, monitors, and CROs, etc.

The documentation requirements including a set of SOPs with key elements to be contained in the SOP will be discussed.

In this 60-min webinar, you will have unparalleled opportunities to bring great value and benefits to your organization and to greatly improve your GCPs with increased awareness of the needs - sustainable compliance and patient safety.

Areas Covered in the Session :

Statutes, Regulations and Definitions

Regulatory Requirements for INDs and IDEs.

Clinical Trials

Clinical Investigators (CI)

Institutional Review Boards (IRBs)

Sponsors and Monitors

Contract Research Organizations (CROs)

ICH-GCP Guidelines

ISO 14155

List of SOPs and Adequate Documentation

Key Elements in the SOPs

Common GCP Deficiencies in EU and US

Enforcement Actions

Lessons Learned

Who Will Benefit:

Clinical Affairs

Regulatory Affairs

Quality Assurance

Research & Development

Consultants

Contractors/Subcontractors

Senior Management

Anyone Interested in the Topic

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this webinar

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1359

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