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.

Regulatory Education for Industry (REdI): Generic Drug Forum – April 3 & 4, 2019

This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) assessment process. FDA will also discuss science unique to generic drug applications.

After this course, attendees will be able to:

  • Discuss requirements for an ANDA
  • Understand and determine when to use a reference listed drug or a reference standard
  • Determine the types of FDA meetings and when to use controlled correspondence
  • Understand the factors resulting in an FDA refusal to receive decision
  • Identify common deficiencies in ANDAs including bioequivalence and quality (e.g. stability, dissolution and impurity testing)
  • Avoid common errors related to the Drug Master File (DMF)
  • And more…

For more info:

Tennessee’s Severe Weather Awareness Week – February 24 to March 2, 2019

Tennessee Gov. Bill Lee announced today that Tennessee’s Severe Weather Awareness Week is Feb. 24 to March 2, 2019, and the Tennessee Emergency Management Agency (TEMA), Tennessee Association of Broadcasters (TAB), and the National Weather Service (NWS) are asking Tennesseans to make severe weather planning and preparedness a priority.

“Severe weather, natural disasters, and man-made threats can happen anytime and increase in magnitude without warning,” Gov. Lee said. “Tennesseans can prepare now for floods, severe weather, and tornadoes so they can be ready to take life-saving actions to protect themselves and their families should the need arise.”

For more info:–emergency-managers—meteorologists-promote-severe-weather-prep-.html

Quality Control Laboratory Compliance – cGMPs and GLPs – March 14-15, 2019 in San Francisco, CA

DA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries – pharmaceuticals, biologics, medical devices, as well as foods and cosmetics – as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.

This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).

For more info: