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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 Course – Industrial Sterilization for Medical Devices – May 10-13, 2022
Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.
Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Students will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.
For more information: https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000007VMBQ
AAMI Virtual Course – Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 – April 18-22, 2022
This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and ANSI/AAMI/ISO 13485:2016.
For more information: https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000008mtBO
AAMI Course – Process Validation Requirements & Industry Practices – April 6-8, 2022
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 information: https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000007VKBd