Webinar On - Good Documentation Practices for Clinical Trials

Online, February 3, 2014 (Newswire.com) - Compliance Trainings focuses on providing regulatory and quality web based online trainings to industry professionals across the globe. Compliance Trainings strives to educate and enhance the knowledge and broaden the horizons of regulatory professionals as well as professionals from the HR, Healthcare and many other industries. Regulatory compliance solutions from the house of Compliance Trainings strictly meet international standards and are fundamentally based on the objective of bringing down client compliance costs. Internationally scalable solutions are fully integrated into every webinar or event and help clients meet stringent demands of GxP, ISO and FDA regulatory authorities.

Compliance Trainings addresses a variety of pivot points that includes the communication of most recent updates in regulatory compliance arena and best practices. Our pool of experienced and knowledgeable industry leaders provide you with the highest level of quality trainings and consulting. Further, information sharing sessions enable exceptional nurturing of ideas and thoughts that culminate in better output. Compliance Trainings uses the latest technology to bring relevant information closer to you through simple, interactive and cost- efficient mediums promising guaranteed proposed solutions.

Scheduled On : Tuesday, February 4, 2014 at 13:00 Hrs

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
• R&D
• Consultants
• Contractors/Subcontractors
• Senior Management
• Anyone Interested in the Topic