How Fixing FDA Compliance Problems (Remediation) Aligns with the 5 Stages of Grief
This webinar will talk about common responses by company leadership when they are facing significant U.S. FDA compliance training problems. Four of the five stages, which happen to align with the five stages of grief felt by individuals facing a significant loss.
Why Should You Attend
This Webinar provides some high level tips on FDA training courses (based on the instructor´s years of experience working with companies facing these problems) on how to minimize the time spent in each of these stages, so that the company can optimize their efforts to solve compliance problems that they may be facing now or could possibly face in the future.
Areas Covered in this Webinar
Denial-Numbness-Shock, Bargaining, Depression, Anger, and finally Acceptance, as it relates to the organizational cycle that companies facing significant U.S. FDA enforcement report go through.
This webinar provides tips on how to more rapidly move on past the negative stages and get to the Acceptance Stage, so that the company can more effectively solve their compliance problem now, or they are not facing FDA compliance problems now, to be prepared just in case their company does find themselves facing compliance problems in the future.
FDA enforcement, public relations nightmare, 483, FDA 483 observations, crisis management training, recall, corrections and removal, public health
Change agents within smaller medical device and biotech companies
Who Will Benefit
VPs - Directors - Managers of Quality and/or Regulatory
VPs - Directors - Managers of Operations
James A. (Jim) Dunning, is the founder and CEO of QPC Services, a regulatory and consulting firm. Jim has more than 25 years of experience working in or consulting with FDA regulated industry, nationally and internationally.
Jim has focused for much of his career on helping companies that are facing "regulatory distress", that is having significant FDA compliance problems. Many of these companies were fortune 500 Life Science firms, but many were smaller medical device and biotech companies.
QPC Services has three core focus areas, and one of these is "remediation", that is the systemic corrective actions taken to resolve significant FDA regulatory problems. Today, Jim´s focus, and consequently the focus of his QPC Services, is almost exclusively on smaller medical device and biotech companies.