Walker Downey & Associates, Inc.
Quality Assurance Services
Quality assurance (QA) is the activity of providing evidence needed to establish confidence among all concerned that quality-related activities are being performed effectively. For healthcare products, and particularly if you are involved with any part of a non-clinical study for a drug, biologic, device or food ingredient, you need to be aware of what the FDA expects from you or your data may not be considered in your application. In that respect, deficiencies in laboratory quality systems can prompt FDA enforcement actions that may go beyond a warning letter.
Walker Downey & Associates QA assures the existence and effectiveness of procedures that attempt to make sure - in advance - that the expected levels of quality will be reached. We cover all activities from design, development, testing, production, installation, servicing to documentation. We will provide you with evidence for the saying "fit for purpose" and we will help you to "do it right the first time". Post-audit by Walker Downey & Associates, our certified QA auditors will explain and discuss the requirements of the Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations as set forth by the OECD and the Food and Drug Administration (FDA), helping you to understand GLP/GMP compliance and to be able to recognize non-compliant situations. We will review your data collection and standard operating procedures; knowledge, responsibilities and training records of personnel; study director or principle scientist qualifications; compliance by sponsors and raw material providers; site management and Quality Management System; and, the regulatory knowledge and performance of your personal Quality Assurance Unit (QAU). Whether you manufacture components/parts or conduct preclinical testing, quality assurance affords fact-based external confidence to customers and other stakeholders that a product meets needs, expectations, and other requirements.
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Walker Downey & Associates will serve as an evidence-based product safety and development quality assurance consultancy for your product or project team from discovery and proof-of-concept through clinical testing. We will help you to personally develop strong regulatory compliant strategies for all areas of product development. Our certified staff has extensive GLP/GMP auditing experience and is highly praised by their peers. Contact us to see how we can help with you with our quality assurance consulting. Learn more |
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Walker Downey & Associates Certified Quality Auditors (CQA) are professionals who understand the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating and reporting to determine a quality system’s adequacy and deficiencies. The CQA analyzes all elements of a quality system and judges its degree of adherence to the criteria of industrial management and quality evaluation and control systems. Contact us to see how we can help you with our quality assurance auditing. Learn more |
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Walker Downey & Associates has worked in the regulated healthcare industry for decades and can provide a thorough assessment of your company’s compliance to pertinent standards and regulations. Our certified scientific and quality assurance auditors have been used internationally to assure that, for example, GLP testing facilities being considered by the client are appropriately accredited and qualified. We can also extend this quality assurance for compliance to your manufacturing process (cGMP). Learn more |
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Supplier Audits are one of the best ways to ensure that the supplier is following the processes and procedures that you agreed to during the selection processes. The supplier audit identifies non-conformances in manufacturing process, shipment process, engineering change process, invoicing process and quality process at the supplier. After the audit, the supplier and manufacturer jointly identify corrective actions which must be implemented by the supplier within an agreed-upon timeframe. A future audit ensures that these corrective actions have been successfully implemented. Contact us to learn how we can help you with our supplier auditing service. Learn more |
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The process of peer review is considered critical to establishing a reliable body of research and knowledge. Regulatory agents charged with acting upon a submission can only be expert in a limited area; thus they welcome and rely to some degree on the third-party peer-review process to lend additional credibility to the research. Walker Downey & Associates will facilitate a quality assurance peer review of preclinical study reports, or other written documents by our certified and experienced staff. Learn more |
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The
art and science of quality assurance.
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