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 Virtual Training – Integrating Risk Management into the Product Lifecycle – June 28-30, 2021

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes.

For more info and to register:

AAMI Virtual Training – Process Validation Requirements & Industry Practices – April 14-16, 2021

Process Validation Requirements & Industry Practices is a 3-day, virtual training that will provide attendees with practical tools and techniques for process validation requirements to meet FDA’s Quality System Regulation, the ISO 13485:2016 Standard, and recognized Process Validation Guidance from the Global Harmonization Task Force. The program will feature industry best practices and real-life process validation examples to guide attendees through the process.

To register:

AAMI Virtual Event – Medical Device Software Validation – March 31 – April 2, 2021

During this 3-day training, learn how to develop and validate medical device software in an ever-changing landscape of regulations and technology. This class will ground you in all the relevant regulations, standards and guidance and help you understand how risk, cybersecurity, cloud computing and mobile apps impact the medical device software space.  It will also challenge you with real-life exercises to give you experience in determining the different classes of software and the activities required for developing and validating that software.

For more info: