Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
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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

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – December 10-14, 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.

For more information:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=6523

 

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – December 3-7, 2018 in Manchester, UK

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.

For more info:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5705

Webinar – Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations – December 6, 2018, 1:00 pm to 2:00 pm

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), is pleased to announce this virtual event.

Issuing the guidance for industry on the use of electronic health record (EHR) data in clinical investigations is part of the agency’s commitment to furthering the advancement and usage of new technologies in scientific and regulatory processes.

For more info:  https://www.fda.gov/newsevents/newsroom/fdainbrief/ucm613793.htm