Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
Welcome to Focus Compliance & Validation Services
Core Regulatory Compliance & Validation Services
Focus Compliance & Validation Services provides consulting services to assist our clients in achieving and maintaining FDA regulatory compliance. Our core areas of expertise include: computer system validation; quality system development, implementation, maintenance, and auditing; response to agency actions including 483s and warning letters; FDA mock inspections and mock recalls; training; risk management; process validation and equipment qualification; and related assistance. We have experience providing these services in the medical device, pharmaceutical, and biotech industries.
Computer Systems Validation
Medical Device Industry
Pharmaceutical Industry
Regulatory Affairs/GXP Compliance
Blood and Plasma Industry
Pharmaceutical Packaging Industry
Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.

AAMI Event – Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 – August 22, 2022

This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and ANSI/AAMI/ISO 13485:2016.

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AAMI Virtual Event – Lead Auditor for Management Systems & Processes – Principles & Practices – August 4-5, 2022

A Lead Auditor is responsible for leading an audit team in an organization—preparing the audit plan, delivering meetings and submitting audit reports. AAMI’s 2-day Lead Auditor course teaches participants the requirements of and how to utilize ANSI/AAMI/ISO 13485. Join us to gain understanding of best practices of auditing quality managements systems as defined in ANSI/ISO 19011.

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AAMI Event: Test Method Validation Workshop – July 19-20, 2022

Test Method Validation (TMV) is not only an FDA regulatory requirement, it is key to quality and financial success for a firm. How do you know that you have quality if you cannot measure? This subject has been called many names, such as Measurement System Analysis (MSA) and Gauge Repeatability & Reproducibility (GR&R). There is an international standard for MSA.

Whatever you call the effort, with a successful implementation you will minimize the risks of rejecting good product and shipping defective product. In one application, the presenter saved a firm $40 million with TMV. This two-part webinar series will cover: set up, sample sizes, metrics for success, and diagnosing & fixing problems. Practical application of valid statistical software will be illustrated. The material is aimed at quality managers, design & process engineers, and practitioners. There is no prerequisite for attendance – no background in statistics is needed.

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