Copyright © 2010 Quality Compliance Partners, Inc.�

For Quality Assurance� expertise, operational advice or assistance, or complete design and management of your QA�

systems, or something in between,� can help.�

Your success depends on compliant, quality products, and you can rely on QCP, Inc. as your Quality and Compliance�

Partner. Your company success demands� ,� , and� . There is�

no need to go it alone. QCP, Inc. will help you meet and conquer these QA challenges.�

Are you developing a revolutionary product? Do you have 5,000 employees or 10 employees? Do you suddenly find yourself�

behind schedule, over budget (or both), with a list of requirements that was supposed to be completed last week? Or are you�

planning in advance to avoid the pain of a last minute crunch?�

At QCP, Inc., we can jump in at any stage of your process. We bring in personnel with the latest industry experience, along�

with additional QA expertise and support on an as needed basis to support your project and help maintain adequate cost�

control.�

QCP, Inc. QA consultants have hands on operation experience and can design, develop, maintain, manage quality assurance�

processes, and operations, including product disposition.�

QCP, Inc. QA consultants are experts at the development of Standard Operating Procedures (SOPs), related documents,�

staff training, and/or review of existing SOPs to ensure that they meet current standards and regulatory requirements.�

Copyright © 2010 Quality Compliance Partners, Inc.�

Quality Compliance Partners, Inc.�

5519 Clairemont Mesa Blvd. #290�

San Diego, CA 92117�

www.qualpartners.com�

Development of compliant quality assurance systems for:�

ü� Batch Review and Disposition�

ü� Annual Product Review�

ü� Change Control�

ü� Deviations, Corrective and Preventive Action�

ü� Training�

ü� Investigations�

ü� Regulatory Inspections�

ü� Complaint Handling�

ü� Returned Goods Handling�

ü� Validation�

ü� Recalls�

ü� Document Control�

ü� Creation and management of QA documents�

ü� Detailed specification development�

ü� Development of document control program�

QCP, Inc. can create and deliver effective customized GMP training programs for experienced and new�

employees.�

QCP, Inc. can be available for on-site support to ensure operations compliance.�

ü� Supplier Qualification and Management, including�

Quality Agreements�

ü� Internal and External audits�

ü� Stability Data Management�

ü� Good Manufacturing Practice Audits / GMP Audits�

ü� Thorough internal GMP self-inspections to current�

regulatory standards�

ü� In-process QA inspections�

ü� QA surveillance plans�

ü� Surveillance audits and/or support during�

government audits of contractors and suppliers�

ü� Inspection Readiness (mock audits)�