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Focus provides proven solutions to the FDA Regulated Pharmaceutical and Biotechnology Industries.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.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 & 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 & 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 LOCATIONFocus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.NEWS AND EVENTS
AAMI Virtual Event: Integrating Risk Management into the Product Life Cycle – October 3-5, 2023
This course will cover risk management principles used throughout the lifecycle of a product (design, manufacturing, post-production, and retirement). Instructors will also identify linkages between risk management processes and quality system processes. Participants will discover how to use regulatory databases to support risk management activities at different stages of the product lifecycle, as well as the use of International Product Safety Standards.
For more information: https://aami.my.site.com/s/lt-event?id=a1Y4U00000IoSSL
AAMI Virtual Event – Design Control Requirements – Integrating the Quality System Regulation – September 12-14, 2023
This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.
Program Objective
Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.
This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding for developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues.
For more information: https://aami.my.site.com/s/lt-event?id=a1Y4U00000IoHgE
AAMI Event – Process Validation Requirements & Industry Practices – August 7-9, 2023
This 3-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Topics include planning, protocol development, validation execution, monitoring & control and re-validation to meet the FDA’s expectations and the industry’s best practices.
For more info: https://aami.my.site.com/s/lt-event?id=a1Y4U00000IoHfk