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Focus provides proven solutions to the FDA Regulated Pharmaceutical and Biotechnology Industries.Focus Compliance and 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.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.Focus Compliance and Validation Services provides engineering and consulting services to primary and contract medical device companies.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.Focus Compliance and 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 ServicesCore Regulatory Compliance & Validation ServicesFocus 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 SERVICESOUR LOCATION
Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.NEWS AND EVENTSQuality System Requirements & Industry Practice Course, June 2017, Instructor Focus’ CVS Mark Walker
Focus’ CVS Mark Walker (also a member of AAMI’s faculty) will be an instructor at the Quality System Requirements & Industry Practice Course, Austin, TX, June 9-12, 2017. The 4-day comprehensive course provides the basic knowledge and skills needed to develop a quality system program that conforms with FDA’s Quality System regulation. For more info: http://www.aami.org/events/eventdetail.aspx?ItemNumber=4116
Quality System Requirements & Industry Practice Course, April 2017, Instructor Focus’ CVS Mark Walker
Focus’ CVS Mark Walker (also a member of AAMI’s faculty) will be an instructor at the Quality System Requirements & Industry Practice Course, Arlington, VA, April 18-21, 2017. The 4-day comprehensive course provides the basic knowledge and skills needed to develop a quality system program that conforms with FDA’s Quality System regulation. For more info: http://www.aami.org/events/eventdetail.aspx?ItemNumber=4008
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Call us today at 865.694.7517 | Email: focus@focusCVS.com
