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.

New M&M Flavor, Hazelnut Spread, to be Manufactured Only at the Cleveland, TN Location

Mars Wrigley Confectionery has just announced a major investment in its Cleveland-based factory of $142M, which it says will lead to 79 new full-time jobs supporting its new M&M’S Hazelnut Spread manufacturing.

Mars says the Cleveland expansion is its latest in a series of commitments to U.S. manufacturing, after the company invested $1 billion over the past five years and created over 1,000 new jobs. This included a $100M expansion in Topeka, Kansas, to support M&M’S Caramel, which the corporation says became the fastest-selling confectionery innovation ever.

The M&M’S Hazelnut Spread will be made in Cleveland with a hazelnut-filled soft center, similar to the M&M’S Caramel.

Mars says it expects to invest millions more in its U.S. supply chain and manufacturing in the coming years, with Cleveland leading its latest charge.


Regenerative Engineering Symposium – October 27-28, 2018 in Pittsburgh, PA

How the convergence of engineering, life sciences, and translational medicine will transform patient care.

The Regenerative Engineering Society of AIChE presents this event that will cover a range of topics on regenerative engineering including Urological, Soft Tissue, Musculoskeletal, and Cardiovascular regenerative engineering.

For more info:

October is National Cybersecurity Awareness Month – Week 3: October 15-19, 2018

Week 3: October 15–19

It’s Everyone’s Job to Ensure Online Safety at Work

  • Business owners and employees should stay on top of current scams and threats that target businesses, such as business email compromise, payroll diversion, and ransomware.
  • For businesses and individuals who are the victim of cyber crimes and scams, reporting is crucial. The FBI uses information gathered from victims to refer cases to the appropriate law enforcement agencies and identify trends. Anyone who is a victim of an Internet-enabled crime should file a complaint with the Internet Crime Complaint Center (IC3).