Independent Review of Planned FDA Responses

During times of complexity and uncertainty, setting the right course of action from the beginning is vital.

The QualityHub advantage is the ability to have one provider who provides the multitude of services needed to manage and execute the program, who also brings in the most highly skilled resources. Using QualityHub as your one-stop consulting service will help reduce or eliminate the risks, conflicts, confusion, rework and increased costs that are known to happen when multiple consulting organizations work on the same remediation project.

QualityHub’s one-stop consulting services for Independent Review of Planned FDA Response support include:

  • Strategic guidance in the creation of a Corrective Action Plan
  • Project execution resources

Senior Consultants who can serve as:

  • Project Lead(s)
  • Project Managers(s)
  • Subject Matter Expert(s) (SMEs)
  • Auditors
  • Senior Advisors
  • Trainers
  • Remediation Management
  • Staff augmentation and temporary personnel replacements

Executive Management Consultant(s) who:

  • Oversee the project
  • Provide the high-level peer review of the project and also help to coach, train and coordinate with Senior Management

Associate Consultant(s) who:

  • Perform day-to-day tasks to review Complaints, CAPAs, NCs and assist in several areas of the project
  • Perform legacy file remediation support in the areas of Design History Files, Risk Files, Complaints/MDRs, CAPAs, Nonconformances, Supplier Files, Process Validations, etc.

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