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

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