2015 - 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-AT-compliancetrainings.com