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

2019 ISPE Global Pharmaceutical Regulatory Summit – December 5-6, 2019 in North Bethesda, MD

This forum brings together leading global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches, and solutions that will drive innovation and quality for the medicines delivered to patients worldwide. This interactive setting with expert-led regulatory and industry presentations and forums will ensure pharmaceutical industry professionals are well-prepared to develop and apply innovative solutions in today’s global regulatory environment.

The Summit will provide attendees the unique opportunity to raise questions and engage in discussion with global regulators and industry experts.

For more info: https://ispe.org/conferences/2019-global-pharmaceutical-regulatory-summit

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – October 28 – November 1, 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. 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 info: https://my.aami.org/store/events/registration.aspx?event=QS1019

2019 ISPE Annual Meeting & Expo – October 27-30, 2019 in Las Vegas, NV

Why Attend

6 extensive education tracks — Facilities & Equipment, Information Systems, Quality Systems & Regulatory, Innovation Forum, Supply Chain, Operations & Packaging and Process Development & Manufacturing
85+ hours of targeted technical sessions, from industry and regulatory leaders
Networking opportunities, including 50+ Plenary and Technical Sessions, Facility of the Year Awards Program, Membership Awards Program, Facility Tours, 5K Charity Run/Walk, Interactive Workshops, Young Professionals Events, and Women in Pharma Events
200+ exhibitors featuring the latest technologies and services
New! ISPE Discovery Stage showcasing cutting-edge modernization in pharma products and services.
2 days of in-depth classroom training courses on 31 October–1 November

For more info: https://ispe.org/conferences/2019-annual-meeting-expo

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.

2019 ISPE Global Pharmaceutical Regulatory Summit – December 5-6, 2019 in North Bethesda, MD

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – October 28 – November 1, 2019 in Arlington, VA

2019 ISPE Annual Meeting & Expo – October 27-30, 2019 in Las Vegas, NV

Why Attend

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.