JVT

Consultant Forum #5: What Happens When Two QMS Systems Run in Parallel Upon a Merger?

Paul L. Pluta, Coordinator

“Consultant Forum” (CF) provides a vehicle for pharmaceutical industry managers and consultants to share information about their interactions in the daily work environment.  Perspectives from both sides of these relationships will be addressed.  The information provided in these discussions should be helpful and practical so as to enable application in actual work situations.  Our objective:  Useful information for both the client and the consultant.

Topics planned for discussion include some theories on motation; factors for lack of motivation; consequences of consultants’ lack of motivation; some tools that clients can use to inspire consultants and technics to increase motivation.  In turn we will rely on successful solutions to problems communicated by our readers.  Suggestions for future discussion topics are invited.  Readers are also invited to contribute manuscripts for this column – please share your successful practices with others.  We need your help to make CF a useful resource.  Please contact coordinator Paul Pluta at [email protected] or content specialist Melissa Carella at [email protected] with comments, suggestions, or topics for discussion.

ABSTRACT

The role of consultants in the pharmaceutical, biopharmaceutical, vaccine and medical device industries is significant.  Consultants provide experienced resources in crisis situations, while new facilities are being installed, under circumstances requiring a high input of technical expertise, during regulatory emergencies, remediations, consent decrees, and other planned and unplanned situations.  Problems often occur between clients and consultants with problems arising between either party. 

Many companies undergo acquisitions where they are running in parallel before Company B (the company being acquired) fully adheres to the QMS of Company A. This results in two Quality Management Systems (QMS) affecting the consultants who were already representing Company A and the consultants of Company B. This article will discuss two QMS system(s) running in parallel, and what to do to increase the probability of success.

Our upcoming feature, CF#6, will discuss what not to do during a merger. 

Some examples, explanations or mini-case studies will be presented at some of the stages of specified topics mentioned in an outlined format within the introduction section. 

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