If you need help with any of the following, you came to the right place...

Scheduling audits (internal or external)...

Responding to audits...

Developing or improving procedures...

Problem solving, problem solving systems, problem solving tools and training...

Regulatory Affairs (See links in Resources below):
  • FDA: audits and inspections, Drug Listing, labeling evaluation
  • DEA: ARCOS reporting, Biannual reporting, Quota Procurement
  • EPA: Establishment Registration, preparing and submitting Pesticide Applications
  • AF&T: Formula submission (Beverage Grade Alcohol and Denatured formulas)

CGMP Finished Pharmaceuticals   FDA Guidances   DEA (Part 1300-end)
Cosmetic Regulations FD&C Act USP Pharmacopeia Convention
Six Sigma IQSR: Device Regulations Drug Listing Homeopathic Pharmacopeia of the United StatesOther Links
The purpose of this business is to provide additional guidance, experience and direction  to address various challenges to your Quality Management System, hence our name "qmsHelpline".  

Our experience is based on 30 years working with a variety of employers and industry contacts spread over related industries, generally heavily regulated industries that operate under FDA, EPA, DEA, AF&T as well as a litany of state and international standards. 

Our services may be used to supplement your own team or to fill temporary or short term needs.

Please permit us to help you with your QMS challenges, great and small.

Quality Management System
Six Sigma (DMAIC)
OEE (Overall Equipment Effectiveness)
A3 Storyboard
Problem Solving A3 (front)

Problem Solving A3 (back)
Process Engineering Mindmap
WSBH versus WAH (PDCA)
Phone : 570 - 245-1280
Fax :
E-mail : info@qmshelpline.com
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