Quality assurance engineering and regulatory compliance consulting support for various companies, including medical device, pharmaceutical, biotechnology, and consumer services.

We are an action-oriented firm with extensive industry experience.  We provide quality assurance engineering and regulatory compliance consulting support for various companies, including medical device, pharmaceutical, biotechnology, and consumer services.  We ensure efficient, cost-effective, and permanent solutions to achieve your business goals.

 

QPC Mission:  Our mission is to serve the business community with services to facilitate growth and development in the area of quality assurance, manufacturing operations, and regulatory compliance to allow organizations to become best in class – true pioneers in their industry.

 

QPC provides a number of services and the necessary tools to aid in the process of quality systems improvement and enhancement, in addition to regulatory compliance.  We ensure adherence to FDA regulations, ISO requirements, and other pertinent regulatory agency standards.

 

 

Services include the following programs and activities:

 

• Process and Product Validation (includes Installation Qualification, Operational

  Qualification,and Performance Qualification)

 

• Hazard Analysis, Failure Modes and Effects Analysis (and FMEcA)

 

• Design Controls, Risk Management

 

• Corrective Action and Preventive Action (CAPA)

 

• Complaint Handling (includes Health Hazard Evaluations)

 

• Nonconforming Product / Material

 

• Gage Repeatability & Reproducibility (R&R)

 

• Change Control / Document Data and Control

 

• Document and Procedure generation (origination, revision, review)

 

• Ensure GD&T and RoHs compliance

 

• Supplier Quality / Purchasing Controls & Inspection plans

 

• Calibration

 

• Statistical Process Control (SPC)

 

• Production Controls, Lean Manufacturing

 

• Environmental Monitoring, Sterilization, Bioburden

 

• Training (includes seminars for current Good Manufacturing Practices, root cause and

  problem-solving techniques, statistics, Six Sigma concepts, and more)

 

• Internal and Supplier Quality Audit (assist in FDA, ISO, other regulatory agency and third

  party audits)

 

• Assist with post audit remediation efforts for quality systems improvement and enhancement

 

• Prepare 510k Regulatory Submissions, CE Mark Technical Files, ongoing Technical Files

 

• Prepare Instructions For Use, Instruction Manual (coordinate multilingual translations)