“This training on Morf Playbook equips staff at FDA regulated companies with information to develop expertly formulated risk management processes to improve safety procedures and reduce downtime."
San Francisco, CA (PRWEB) March 08, 2016
Morf Media Inc., developer of Morf Playbook™ talent development, skill-building and compliance training platform for use on mobile devices and PCs, today released an interactive course on Risk Management and Drug Surveillance. The latest Morf Playbook course for FDA regulated companies provides clear guidance to managers and quality assurance personnel on how to follow regulation expectations and formulate their own risk management practices based on existing reporting and surveillance program.
“I’m proud to announce our latest course on Risk Management and Drug Surveillance on Morf Playbook,” said Angela Bazigos, chief compliance officer at Morf Media Inc. “This training equips staff with information to develop expertly formulated risk management processes to improve safety procedures and reduce downtime."
The Morf Playbook course provides personnel with training on following regulation expectations. It provides step by step guidance on how to formulate and create company specific risk management practices based on existing reporting and surveillance programs.
Topics covered include the following:
- Basic concepts of the drug registration and listing process, including DUNS number
- An overview of the Adverse Drug Experience (ADE) Reporting Program, including the FDA CDER’s ADE Training Video
- An introduction into the Drug Quality Reporting System (DQRS)
- Comprehensive risk evaluation and mitigation (REMS) strategies
- Elements to Assure Safe Use
- Implementation of REMS
- Enforcement of REMS
- Misbranding and Civil Penalties
Morf Playbook provides a growing list of courses for 2016 FDA Compliance Training Series with certificates of completion for use toward continuing education units. The new courses include the following topics:
21 CFR Part 11
Cosmetics - How Are They Regulated
Drug Discovery and Development - The FDA Way
Writing Effective SOPs
Excel Spreadsheet Validation for 21 CFR 11
HIPAA Best Practices
FDA Direct: Establishment Registration and Listing
FDA Direct: Overview of Regulatory Requirements for Medical Devices
FDA Direct: Risk Management & Drug Surveillance
FDA Inspection - Key Factors for a Successful Inspection
FDA Inspections – 21 CFR 11 and Computer System Validation
FDA Inspections - Managing Inspection Outcomes
FDA Inspections - Managing Regulatory Risk
FDA Inspections - Organization Readiness
FDA Inspections - Program Overview
FDA Inspections - Quality System Readiness
FDA Quality Metrics – Latest Advances
Good Clinical Practices
Good Documentation Practices
Project Management for 21 CFR 11 & CSV
Key Factors for an FDA Inspection
European Data Protection Reform
The courses are individually available and are also available with the complete Morf Playbook training system. With its built-in authoring, reporting tools and analytics to measure an individual’s progress, Morf Playbook provides a complete secure training delivery platform. It provides personalized recommendations for remediation, course progress and completion tracking, exam proficiency and certificates of achievement.
For more information about Morf Playbook courses and Morf Playbook platform, visit Morf Media.com or contact Natalia Glatcovschi at email@example.com.
About Morf Media, Inc.
Morf Media, Inc. is shaping the future of enterprise talent development and compliance training with Morf Playbook™. The mobile platform provides one-to-one leadership, development, skill building and training on a smart phone, tablet or PC. Morf Playbook delivers interactive courses using a variety of media, including audiobooks and video. Its patented mobile framework offers an engaging way to empower people to perform at their best while providing individuals, team leaders and managers with reporting, metrics and communication tools to optimize talent and performance. Founded in 2013 by a seasoned management team, the company is based in San Francisco with offices in the Silicon Valley. For more information about Morf Media, please visit: http://www.morfmedia.com
Vice President Marketing of Morf Media, Inc. USA