Focus Compliance & Validation Services

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Pharmaceutical Industry
Focus provides proven solutions to the FDA Regulated Pharmaceutical and Biotechnology Industries.
Consulting Services to the Pharmaceutical Packaging Industry
Focus Compliance & Validation Services provides engineering and consulting services to primary and contract pharmaceutical packaging companies. These services include the implementation of systems, procedures, and documentation to meet the FDA Quality System regulations affecting the packaging industry.
Computer Systems Validation
The FDA and other regulatory agencies have established criteria for software-based applications developed for use within the pharmaceutical, biological, and medical device industries. Focus personnel have experience with computer systems validation activities and provide services for a full range of validation deliverables, from Validation Plans through Validation Summary Reports.
Consulting Services to the Medical Device Industry
Focus Compliance & Validation Services provides engineering and consulting services to primary and contract medical device companies.
Regulatory Affairs and GXP Compliance
Focus provides innovative solutions to the FDA regulated industries. Our regulatory compliance specialists work closely with the FDA to ensure our clients have the latest information available and can quickly assess the impact of regulations.
Consulting Services to the Blood and Plasma Industry
Focus Compliance & Validation Services provides engineering and consulting services to the human blood and plasma collection industry. These services include the implementation of systems, procedures, and documentation to meet the FDA Quality System regulations affecting the blood and plasma industry.

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

Quality Control Laboratory Compliance – cGMPs and GLPs – March 14-15, 2019 in San Francisco, CA

DA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries – pharmaceuticals, biologics, medical devices, as well as foods and cosmetics – as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.

This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).

For more info: https://www.complianceonline.com/quality-control-laboratory-compliance-cgmps-and-glps-seminar-training-80085SEM-prdsm

Call for Abstracts (deadline February 28) – 8th International Conference on Bioengineering and Nanotechnology – May 28-31, 2019 in Baltimore, MD

Presented by the Society for Biological Engineering (SBE), the 8th International Conference on Bioengineering and Nanotechnology will bring together leaders and trainees from cutting edge fields of bioengineering and nanotechnology. Topics to be presented include: biomolecular engineering, translational medicine, cell engineering, immunoengineering, and mechanobiology. The global objective of the conference is to bring to the forefront truly transformational development in bionanotechnology.

Call for Abstracts by February 28 to one of the following Session topics:

‣ Biomolecular engineering

‣ Translational medicine

‣ Cell engineering

‣ Immunoengineering

‣ Mechanobiology

Submissions info: https://aiche.confex.com/aiche/icbn19/cfp.cgi

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – February 4-8, 2019 in Arlington, VA

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 to register: http://www.aami.org/events/eventdetail.aspx?ItemNumber=7179

Pharmaceutical IndustryFocus provides proven solutions to the FDA Regulated Pharmaceutical and Biotechnology Industries.

Consulting Services to the Medical Device IndustryFocus Compliance & Validation Services provides engineering and consulting services to primary and contract medical device companies.

Regulatory Affairs and GXP ComplianceFocus provides innovative solutions to the FDA regulated industries. Our regulatory compliance specialists work closely with the FDA to ensure our clients have the latest information available and can quickly assess the impact of regulations.

Quality Control Laboratory Compliance – cGMPs and GLPs – March 14-15, 2019 in San Francisco, CA

Call for Abstracts (deadline February 28) – 8th International Conference on Bioengineering and Nanotechnology – May 28-31, 2019 in Baltimore, MD

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – February 4-8, 2019 in Arlington, VA

Pharmaceutical Industry
Focus provides proven solutions to the FDA Regulated Pharmaceutical and Biotechnology Industries.

Consulting Services to the Medical Device Industry
Focus Compliance & Validation Services provides engineering and consulting services to primary and contract medical device companies.

Regulatory Affairs and GXP Compliance
Focus provides innovative solutions to the FDA regulated industries. Our regulatory compliance specialists work closely with the FDA to ensure our clients have the latest information available and can quickly assess the impact of regulations.