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 Event – Corrective & Preventive Action Requirement & Industry Practice – June 27-28, 2022

This 2-day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and / or validating actions; how to write good CAPA plans; how risk management is used in conjunction with the CAPA system; and 21 CFR and ISO 13485 requirements.

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AAMI Course – Medical Device Cybersecurity 101 for HTM Professionals (Exchange 2022) – June 3, 2022 in San Antonio, TX

Today the news is inundated with stories about cybersecurity compromised businesses, public services, and government operations.  Among those we often hear as being compromised are hospitals and healthcare-related organizations.  When compromises to healthcare organizations do occur, they have frequently shut down a department’s or an entire organization’s operations so that their ability to deliver healthcare and even patient safety can be adversely affected in a severe way.

While advancements in medical technology in recent years have led to great improvements in healthcare delivery, those same technology advancements are also creating new cybersecurity risks that, if not properly mitigated, could produce disastrous effects for healthcare organizations and their patients.  The first step in mitigating the growing cybersecurity risks associated with medical technology is to educate the CE/HTM community.

Attendees of the Medical Device Cybersecurity 101 for HTM Professionals session will have:

  • a general understanding of today’s growing cyber threat landscape as well as cybersecurity concepts and terminology
  • an appreciation of the medical device cybersecurity risks that exist today
  • an understanding of the processes necessary for implementing an effective medical device security risk management program
  • a familiarity with regulations as well as appropriate standards and guidance associated with medical device security and how they should be applied
  • the ability to integrate medical device cybersecurity effectively into an organization’s other information security processes and the organization’s emergency plan

For more information:

AAMI Virtual Course – Industrial Sterilization for Medical Devices – May 10-13, 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.

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