Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
Loading...
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.
OUR SERVICES
Computer Systems Validation
Medical Device Industry
Pharmaceutical Industry
Regulatory Affairs/GXP Compliance
Blood and Plasma Industry
Pharmaceutical Packaging Industry
CONTACT FOCUS CVS
OUR LOCATION
Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.
NEWS AND EVENTS

FDA Study Data Technical Conformance Guide Webinar – November 27, 2018, 1:30 pm to 2:30 pm ET

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes you to our webinar series.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation.  The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

For more info:  https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm625287.htm

FDA Clinical Investigator Training Course – November 13-15, 2018 in Silver Spring, MD

Experts from FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), the University of Maryland and the University of Pennsylvania will provide a deep dive into the scientific background and practical methodology needed when conducting clinical trials.
In this intensive course, attendees will learn FDA regulations, ethical considerations, and the scientific principles to help them understand what is important when conducting clinical trials and preparing a submission for FDA review.

About the Training Course

Topics include:

  • Preclinical and clinical science
  • Statistical structure of trials
  • Safety and ethical requirements
  • FDA regulatory requirements related to the performance and evaluation of clinical studies
  • Non-clinical, early clinical, and phase 3 studies
  • Issues in the design and analysis of trials

For more info:  https://www.fda.gov/training/clinicalinvestigatortrainingcourse/default.htm

 

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 – Navigating Regulatory Requirements: October 29 – November 2, 2018 in Arlington, VA

The regulatory world for quality management systems (QMS) is changing fast. To succeed in today’s global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.

For more info and registration:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=6522