A less than perfect inspection has the potential to attract FDA observations. But if you proactively identify and mitigate the compliance risks, you can still achieve good inspection results and avoid or minimize negative impact on your business.
San Francisco, CA (PRWEB) June 17, 2015
Morf Media Inc., defining the future of compliance training for the mobile workforce, today announced it is co-sponsoring a live seminar on Food and Drug Administration (FDA) inspection procedures with World Compliance Seminars. The seminar, conducted by FDA Investigator Larry Spears and Morf Media Chief Compliance officer Angela Bazigos, takes place in Burlingame, June 18-19. Register here for the event or call + 1 650-340-8500.
“A less than perfect inspection has the potential to attract FDA observations,” said Spears, a retired FDA investigator. “But if you prepare, proactively identify and mitigate the compliance risks, you can still achieve good inspection results and avoid or minimize negative impact on your business.”
The seminar is designed to provide proactive guidance to quality engineers, regulatory affairs and validation auditors, risk managers, compliance officers and senior management. Bazigos and Spears will present best practices and tools to empower participants 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 to 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
“The FDA inspection is one of the critical measures for success for your product and your organization as a whole,” said Bazigos. “This proven course will provide participants with the knowledge and the tools to build a solid foundation for passing FDA inspections from the perspective of the FDA inspector-valuable information to share with your teams that will benefit your company today and in the future.”
For those who cannot attend the workshop, online training for this course will be available via Morf Learning in July. Developed by Bazigos and veteran training e-learning experts Ginger Bell and gamification leader, Yu-Kai Chou, the FDA Investigation training course provides an engaging playbook for companies of any size to offer cost-effective training to their staff and partners and track proof of examination.
Morf Learning is optimized to make enterprise compliance training effective for professionals on the go. The FDA Investigation training course is among a library of certified courses that are delivered in an innovative way to support learning, engagement, measurement and achievement. Morf Learning is a software-as-a-service platform that offers powerful analytics that show an individual’s progress, strengths and areas needed for improvement, proof of preparation for audits and more.
Morf Learning delivers digital compliance training with patented technologies that personalize learning, measure progress and reward achievement. For managers, the Morf Learning platform streamlines compliance training management, administration and reporting for proof of examination and audits.
For more, please visit http://www.morflearning.com
- Twitter @morfmediainc
- LinkedIn: http://www.linkedin.com/company/morf-media
About Morf Media, Inc.
Morf Media, Inc. is transforming enterprise compliance training into playbooks for the mobile workforce. For the first time a digital training system, Morf Learning,™ provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 companies and partners in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging with its game-style courseware. Morf Learning with Morf Playbooks™ deliver interactive three minute courses and a virtual Coach,™ which empowers professionals to train, reference policy details and get reminders and compliance notifications on the go. As a mobile platform-as-a-service, Morf Learning offers secure centralized reporting for managing governance, regulatory and compliance training on a sustained basis. Founded in 2013 by a seasoned management team, the company is based in San Francisco.
For more information about Morf Media, please visit: http://www.morfmedia.com.
For crowdfunding information about Morf Media, please visit Angel List, Gust or Equitynet.
Vice President Marketing of Morf Media, Inc. USA