Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
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.

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.

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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

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Manufacturing Leadership Development Series – Module 7: Delegating Effectively – October 15, 2019 – 9 am to 12 noon ET

It is difficult in the day to day whirlwind to properly delegate and get the results that you are looking
for. This module will take you through a step by step process for delegating effectively. Learn how to
spend your time as a leader more productively and understand “SIMPLE” delegation methods.

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