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The Road to Remediation Is Paved With Resources

October 16, 2013
When a company is hit with multiple quality issues, it must develop a quality remediation plan to get back into good graces with the FDA. But where should a company start, and how can it be sure that the plan won’t impact day-to-day production?

Quality consultant Marie McDonald offers some common-sense tips on how to create an effective remediation program. McDonald, senior director of quality and compliance consulting for Quintiles, is a speaker at FDAnews’ Eighth Annual FDA Inspections Summit, which runs Oct. 23-25 in Bethesda, Md.

McDonald recommends:

  1. As a first step, talk with the FDA and develop a relationship with the district office, particularly the agency branch that identified the quality issues;

  2. Make sure your company has the resources to implement any remediation plan. She said the plan should have the right mix of resources to execute the plan but also keep operations going;

  3. Meet with management and staff to change the way the business operates. “The underlying issue of what is happening is something that requires a culture shift,” she said;

  4. Identify whether you need to hire a third-party quality consultant to provide outside perspective; and

  5. If you do hire a consultant, she added, make sure “your employees are partnering with those consultants and have the resources dedicated to a remediation effort.” Employees need to be able to retain and pass on the consultant’s knowledge.

To gain more insight about FDA inspections, register to attend FDAnews’ Eighth Annual FDA Inspections Summit, Oct. 23-25.