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

MDIC Releases Case for Quality CAPA Process Improvement Whitepaper

Medical Device Innovation Consortium/MDIC’s Case for Quality program today released a whitepaper recasting the Corrective and Preventive Action (CAPA) process as a continuous improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The whitepaper summarizes the initial findings and recommendations developed by a joint team from MDIC, the medical device industry, strategy consultants, and the FDA, including a proposed framework for risk-based improvement.

For more info and to download whitepaper – https://mdic.org/news/mdic-releases-case-for-quality-capa-process-improvement-whitepaper/?utm_campaign=coschedule&utm_source=twitter&utm_medium=MDIConline

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – December 9-13, 2019

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.

For more info and registration:  https://my.aami.org/store/events/registration.aspx?event=QS1219

2019 ISPE Global Pharmaceutical Regulatory Summit – December 5-6, 2019 in North Bethesda, MD

This forum brings together leading global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches, and solutions that will drive innovation and quality for the medicines delivered to patients worldwide. This interactive setting with expert-led regulatory and industry presentations and forums will ensure pharmaceutical industry professionals are well-prepared to develop and apply innovative solutions in today’s global regulatory environment.

The Summit will provide attendees the unique opportunity to raise questions and engage in discussion with global regulators and industry experts.

For more info:  https://ispe.org/conferences/2019-global-pharmaceutical-regulatory-summit