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 In Person and Virtual – Design Control Requirements – Integrating the Quality System Regulation – November 30 to December 2, 2022

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.

Program Objective 

Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.

This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding for developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues.

For more information:

AAMI Event – Sampling Plans-Made Easy – November 16 and 17, 2022

Event Overview

To the casual observer, Sampling Plans can be incredible complex and hard to apply. Worse yet, the subject is a jungle with non-intuitive jargon and crazy acronyms. So why bother?

  1. The key advantage is that Sampling Plans can save time, money and resources. It certainly answers the question: “How much is enough?”
  2. Sampling plans help decision makers understand the risk involved in accepting a product or process.
  3. Well-designed training can cut through the jungle and provide a clear pathway.

This workshop provides a set of simple-to-follow procedures that will keep-it-simple to apply. A wide variety of industry applications will motivate the subject. While the terminology and acronyms used are “industry standard”, participants will not be burdened with statistical complexity. Participants do not need any background in statistics.

For FDA-regulated companies, sampling is a key statistical method used for Design Control, Process Validation, CAPA, Complaint Monitoring, and for Receiving, In-Process, & Finished Device Acceptance. We will discuss the recommendations of the guidance documents developed by the FDA and the Global Harmonization Task Force (GHTF) along with industry standards.

There are two interactive webinars in this workshop. Each webinar is two hours.

  1. Acceptance Sampling Plans for Variable Inspections | November 16, 2022 | 1:00-3:00pm Eastern
  2. Acceptance Sampling Plans for Inspection by Attribute | November 17, 2022 | 1:00-3:00pm Eastern


For more information:

AAMI Virtual Event – Production and Quality System Software (Nov22) – November 3-4, 2022

This course is designed to understand what is and what is not production and quality system software that is required to be validated by FDA and ISO 13485 and will show the methods and tools used to validate Process and Quality System using a software lifecycle process.

Program Objective

Participants will learn about the software life cycle of Production and Quality System software used for the various elements of Medical Device Quality Management System, Calibration, design and development of medical devices, manufacturing and automated production systems software. The course covers the basic elements and strategies for efficiently conducting software validation as required by 21CFR820, ISO 13485, and MDSAP.

In addition, participants will learn how to select the appropriate tools from the applicable technical information report (ISO 80002-2) and guidance (GPSV) for automated production system software, enterprise, custom developed, off-the-shelf (OTS), spreadsheet, and cloud-based applications.

For more information: