Ford and Associates Services

Global Quality Systems Management Solutions

Ford and Associates

Lean compliance strategies for today's complex global regulatory challenges.

Projects

In 2009, Ford and Associates provided a wide variety of quality and compliance services to a broad client base. We work with a wide range of devices and technologies including obstetrics/gynecology, clinical chemistry, physical medicine, radiology, neurology, immunology, pathology and hematology, including a tubal occlusion insert (permanent contraception), point of care blood chemistry analyzer and colorimetric reagent test panels, glucometer and insulin delivery system, carboxhymoglobin assay, power inflatable tube massager, medical image (CAD) analyzer, evoked response auditory stimulator, automated cell-locating device, automated image analysis microscope, and differential cell counter, CAD software, and a water circulating hot / cold pack. Below is a general summary of projects we've worked on in the last year.

Quality Assurance Management

Ford and Associates has provided Quality Assurance Management for a Class III software device manufacturer, a Class II therapeutic device manufacturer, and a Class II diagnostic device manufacturer and assisted these clients in establishing sustainable quality assurance functions with a focus on efficiency.

Quality System Implementation

We recently implemented a full quality management system compliant with 21 CFR 820 for a Class III software device manufacturer, and contributed to its PMA submission. Following the complete implementation of the quality system, Ford and Associates facilitated a Management Review meeting, provided training, and conducted a mock Pre-Approval Inspection (PAI). Ford and Associates also implemented a 13485:2003 quality system for a Class II manufacturer. The organization received its certification with no nonconformities.

Trade Complaint

Ford and Associates was commissioned to conduct a claims audit of marketing material on behalf of a Class II manufacturer who discovered false and misleading advertising. Ford and Associates assisted the client in engaging regulatory counsel, and wrote the basis of a trade complaint with FDA.

510(k) Submission

Ford and Associates authored and submitted a 510(k) for a Class II manufacturer.

Complaints / MDR / Vigilance

Ford and Associates assisted a Class III device manufacturer in reviewing multiple years of complaint data, after the company discovered gaps in the vigilance system. We assessed thousands of complaint records and documented reporting determinations to bring the client's process into compliance. Following our assessment and recommended changes to the vigilance system, FDA conducted a facility inspection with no 483 citations in this area.

Combination Products

Ford and Associates conducted a gap analysis and implemented procedures to bring a drug/device combination product manufacture into compliance with proposed rule 21 CFR Part 4. We established a quality manual combining the specific requirements of Part 4 with ICH Q10 requirements for a quality manual, then provided key members of the organization with training in design control, CAPA, Complaints / MDR, Management Review,

Internal Audit

Ford and Associates is regularly commissioned to conduct internal audits for its clients. In the passed year, we have conducted internal audits for several Class II and Class III manufacturers that sought an indepedant auditor due to resource constraints. Our auditors are certified by RAB/QSA and we conduct audits in accordance with ISO 19011.

Supplier Audit

In the passed year, Ford and Associates has conducted supplier audits for Class II and III, and combination product manufacturers. Audited organizations include sub-assembly manufacturers, PCBA manufacturers, contract manufacturers, packaging and labeling supplier, medical power supply manufacturer / distributor. Our auditors are certified by RAB/QSA and we conduct audits in accordance with ISO 19011.

Gap Analysis

Ford and Associates assisted a drug/device combination product manufacturing in identifying gaps in its quality management system prior to a FDA PAI. By identifying key issues early in the process, the company was able to plan and address nonconformities before the investigators arrived.

483 Response

After a grueling two-week FDA inspection, resulting in 11 483 citations and the issue of an affidavit, a Class II manufacturer commissioned Ford and Associates to establish an appropriate response to FDA. We provided a comprehensive review of the citations, and developed an effective corrective action plan. The plan was accepted by FDA and over the course of four months, Ford and Associates implemented corrections and continued follow up with the Agency. The 483 was effectively closed without additional enforcement action.