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.
Computer Systems Validation
Medical Device Industry
Pharmaceutical Industry
Regulatory Affairs/GXP Compliance
Blood and Plasma Industry
Pharmaceutical Packaging Industry
Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.

Design Control Requirements and Industry Practice – May 28 – 30, 2018 in Dun Laoghaire, Dublin, Ireland

This intensive 2½ day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. The content focuses on the how-to’s of implementing a program that meets FDA’s design control requirements while ensuring a fast and efficient flow of new products.

For more info:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5689

Healthcare Technology Management Week – May 20 – 26, 2018

This annual celebration is designed to promote the awareness of—and appreciation for—the critical work of biomedical equipment technicians (BMETs), clinical engineers, and other members of the healthcare technology management (HTM) field.

For more info:  http://www.aami.org/events/content.aspx?itemnumber=1236&navItemNumber=566

Webinar: Test Method Validation for Quality Systems – May 16, 2018, 11 am – 1 pm

The webinar will provide a working knowledge of Test Method Validation (TMV), also known as Measurement System Analysis (MSA) and Gauge R&R (GR&R). Concepts covered are also applicable to Analytical Procedures. The names are not important, the application of this very valuable statistical methodology is essential for a quality system. The key question is: How do you know that you have quality if you cannot measure it?

The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do NOT need to have a background in statistics.

The methodologies presented conform to the ISO standard on Measurement System Analysis (ISO/TS 16949). The presentation will discuss the Gauge R&R recommendations of the Global Harmonization Task Force’s (GHTF) Process Validation Guidance.

For more info:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5749