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, October 1-5, 2018 in Dun Laoghaire, Ireland

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 information:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5698

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – September 24-28, 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 information and registration:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5697

Webinar – Newly Released Data Behind FDA’s Historic Clearance of IDx-DR – Wednesday, August 29, 2018 from 12:00 pm to 12:30 pm CDT

The technology known as CRISPR — clustered regularly interspaced short palindromic repeats — has taken the field of synthetic bioengineering by storm. It emerged as a gene-editing tool only five years ago, but has become a familiar presence in the lab.

The benefits of synthetic bioengineering with CRISPR

CRISPR-Cas9, the full name for the editing system that uses the Cas9 enzyme as molecular scissors, cuts DNA at any desired location. CRISPR’s versatility makes it a popular tool for current and future research projects. Engineers and scientists are using CRISPR to modify and repair DNA in single organisms, create cell and animal models to help accelerate disease and clinical research, and develop CRISPR-based gene drives that can disrupt the spread of animal-borne diseases.

For more information:  https://www.aiche.org/chenected/2018/06/editing-genes-one-sequence-time