SAN FRANCISCO--(BUSINESS WIRE)--Morf Media Inc., shaping the future of enterprise talent development and compliance training, today announced an interactive FDA compliance training course, 21 CFR 11 - Basic Concepts on Morf Playbook™. The RAPS (Regulatory Affairs Professional Society) accredited course on Morf Playbook—now conveniently available on smartphones and PCs--provides an overview of the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures.
The Challenge
Computer systems have revolutionized the way that companies in regulatory industries can utilize electronic information, records and electronic signatures. With the emerging utilization of computerized technologies in the late 1980s and early 1990s, the pharmaceutical industry asked the FDA for guidance regarding compliance of the resulting electronic records. After several years of development and industry comments, 21 CFR Part 11, the Electronic Records and Electronic Signatures Rule became law in 1997. International regulatory agencies adopted similar e-records/e-signature regulations. However today, more than 15 years after introduction, compliance with the requirements of Part 11 (as the regulation is now commonly referred to) continues to challenge the industry.
At a high level, Part 11 ensures that companies and organizations implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. Part 11 essentially allows any paper records to be replaced by an electronic record, and allows any handwritten signature to be replaced by an electronic one.
The online course, 21 CFR 11 - Basic Concepts, provides an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements, and electronic signatures requirements. It includes the following:
- History and Overview
- Subpart A: General Provisions
- Subpart B: Electronic Records
- Subpart C: Electronic Signatures
- Scope and Application Guidance
“Computer systems and mobile devices have changed the way that we work, learn and go about our day,” said Angela Bazigos, chief compliance officer at Morf Media Inc. “Whether it is a smartphone in our pocket with the latest apps, a tablet device in our lab or a desktop computer in our office, using technology for training is proving to have a positive impact on business productivity and efficiency. The course on FDA 21 CFR Part 11 regulations on Morf Playbook is a natural evolution in how we can consume and distribute information – a parallel with how our industry now manages records electronically in place of paper records.”
Morf Playbook is a complete training system. It offers built-in rapid authoring for proprietary company training and offers a library of prepared courses like the 21 CFR 11 Basics Concepts, developed by FDA training experts.
With its built-in reporting tools and analytics to measure an individual’s progress, Morf Playbook provides a secure platform with personalized recommendations for remediation, tracks course progress and completion, exam proficiency and provides certificates of achievement.
The Morf Playbook 2016 FDA Compliance Training Series provides certificates of completion for use toward continuing education units. The growing list of courses include the following:
| Corrective and Preventive Action |
| Cosmetics - How Are They Regulated |
| Drug Discovery and Development - The FDA Way |
| Writing Effective SOPs |
| Excel Spreadsheet Validation for 21 CFR 11 |
| 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 - Food Facility Inspections |
| FDA Inspections - Information Readiness |
| 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 |
| 2016 HIPAA Best Practices |
| Project Management for 21 CFR 11 & CSV |
|
Key Factors for an FDA Inspection
European Data Protection Reform |
For more information, visit Morfmedia.com or contact Natalia Glatcovschi at natalia@morfmedia.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
