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

Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings – June 20-21, 2019 in Philadelphia, PA

Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.

In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.

For more more about seminar: https://www.complianceonline.com/fda-meetings-ind-ide-applications-preparation-and-submission-seminar-training-80576SEM-prdsm

Webinar: CDER/CBER – Identification of Medicinal Products Initiative – June 13, 2019 – 1:00 pm to 2:30 pm ET

FDA subject matter experts will introduce the Identification of Medicinal Products (IDMP) initiative, scope, and benefits. They will also discuss FDA’s approach and challenges with the adoption of the five International Organization for Standardization (ISO) standards. The goals, objectives and timeframe for the development and implementation of the Global Substance Registration System’s (G-SRS) will also be covered.

For more info: https://events-na12.adobeconnect.com/content/connect/c1/1315899612/en/events/event/shared/2401962854/event_registration.html?connect-session=na12breezv2ocfpxkqk2oq2ct&sco-id=2402031701&_charset_=utf-8

Knoxville Chamber of Commerce – Shrimp Boil 2019 – June 13, 5 to 7 pm

The Shrimp Boil will feature great food, music, and top business and community leaders. Elected officials and others from across Tennessee have been invited to this extraordinary affair.

Casual attire is encouraged!

Location: Jackson Terminal, 213 W. Jackson Avenue, Knoxville

Cost: $35 for members, $45 for non-members

Purchase your tickets at eventbrite.com https://www.eventbrite.com/e/shrimp-boil-2019-tickets-53026144626

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.

Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings – June 20-21, 2019 in Philadelphia, PA

Webinar: CDER/CBER – Identification of Medicinal Products Initiative – June 13, 2019 – 1:00 pm to 2:30 pm ET

Knoxville Chamber of Commerce – Shrimp Boil 2019 – June 13, 5 to 7 pm

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.