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 – Introduction to Combination Products and Regulations: A Risk-Based Approach / Expert Susan Neadle – February 2, 7, 9, 14, 16, 21, 2022 / 1:00-3:00 pm ET

From software as a medical device, to the growing field of biologics, to the enhancement of medical devices with medicinal substances, the scope of products considered combination products continues to expand.


Join industry-renowned instructor Susan Neadle to deepen your understanding of the ever-evolving regulatory landscape of combination products, including navigating and applying requirements and recommendations from 21 CFR Part 4, and TIRs 48 and 105, as well as gain familiarity with interpretations within the emerging global marketplace.

For more information and registration:

AAMI Course – Quality Systems Regulation 21 CFR and ISO 13485 – January 31, 2022 – February 4, 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.

For more information and to register:

AAMI Course – Industrial Sterilization for Medical Devices – January 18-21, 2022

Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Students will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.

For more information: