MRO Magazine

Global Healthcare, Pharma, Biotech and Device Makers Select FDA Investigation Training from Morf Media Inc. and World Compliance Seminars


February 3, 2016
By Business Wire News

SAN FRANCISCO

Morf Media Inc., shaping the future of enterprise talent development with compliance training, today announced Morf Media chief compliance officer and FDA compliance training expert, Angela Bazigos, in partnership with World Compliance Seminars, is hosting FDA Investigation training with a Risk Driven Approach in San Diego Feb. 4-5, 2016. Register here for this powerful two-day seminar for only $895. Additional locations for the workshop are Frederick, Maryland, June 9-10, and Chicago, Illinois, December 1-2.

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The peer recommended interactive workshop, selected by professionals at global healthcare, pharmaceutical, biotech and medical device manufacturing organizations, has been pre-approved by RAPS (Regulatory Affairs Professional Society) as eligible for up to 12 credits towards a participant’s RAC (Regulatory Affairs Certification) recertification upon full course completion.

While the course will focus on FDA inspections, procedures for inspections by other regulatory authorities such as European and Japanese regulatory authorities will be compared and contrasted to an FDA Inspection. The complete course is designed to provide proactive guidance to quality assurance regulatory affairs and validation auditors, risk managers, compliance officers and senior management. Bazigos presents best practices and tools to empower personnel, managers and executives to simplify management of the following:

  • Assess quality system readiness for FDA inspection
  • Identify compliance risks
  • Mitigate before, during and after the inspection
  • Follow up procedures to FDA Form 483, issued at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
  • Responses to warning letters

For those who cannot attend the course in person, the comprehensive FDA Inspection training course is available as an interactive course on smartphones or PCs. Available online, the full list of accredited courses are here: 2016 FDA Compliance Training Series. This comprehensive list on Morf Playbook offers certificates of completion for use toward continuing education units. A list of the top picks here:

21 CFR 11: Basic Concepts

Corrective and Preventive Action
Cosmetics – How Are They Regulated
Drug Discovery and Development – The FDA Way

European Data Protection Reform

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

Writing Effective SOPs
Key Factors for an FDA Inspection

The growing list of online courses is now available on Morf Playbook, a complete system for authoring, delivering certified courses, measuring an individual’s progress, and rewarding achievement. With its patented technologies for use on mobile devices, Morf Playbook takes into account the employees’ motivations, interests and strengths, empowering them to realize their full potential on a secure and easy to use platform. “This proven course from world-class training partners, World Compliance Seminars and Morf Media Inc., provides participants with the knowledge and the tools to build a solid foundation for passing FDA inspections from the perspective of the FDA inspector. Ultimately this training supports a relationship of advisory and offers value for professional excellence, and for helping to ensure your innovative and life-saving product can get to market to patients in need,” added Bazigos.

For more, please visit www.morfmedia.com

About World Compliance Seminars, Inc.

WCS Consulting Inc. has the top industry experts and consultants in the country. Our onsite trainers and consultants are dedicated to providing you with the most useful and up-to-date information available at the most reasonable price. Our trainers and consultants will exceed your expectations by providing top quality training that will meet your training objectives. For more information, visit https://worldcomplianceseminars.com. Contact us for Seminar Booking Toll Free 844-267-7299
support@worldcomplianceseminars.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

Morf Media, Inc. USA
Heidi Wieland
Vice President Marketing
805-722-7413
Heidi@morfmedia.com