FDA / Third-Party Audit Support

Proactive preparation and management of your FDA (or other Agency) inspection will directly correlate with fewer official citations. Ask our Clients about the “revolutionary” impact and value they experienced via the following ComplianceAcuity solutions (click an item for details):

QS/GMP Training, including organic Q&A

During the “calm before the storm”, there is a unique opportunity to receive organic cross-functional agency-specific QS/GMP training.  This can be especially valuable regarding pre-announced audits, as the training can be tailored for the immediate context of a particular compliance scenario.

Ultimately, such training has served to fortify our Clients’ most pressing regulated business operations.  Examples include critical topics such as:

  • Surviving an Audit Interview/Interrogation
  • General QMS/GMP
  • CAPA
  • Complaint Handling
  • Nonconforming Product
  • Product Development
  • Manufacturing Controls
  • Management Responsibility

ComplianceAcuity routinely provides such training, including collaborative efforts with agency representatives, to medical device companies.  Recent attendees include CEO’s, design engineers, production managers and operators, and of course RA/QA staff.  Be sure to review ComplianceAcuity’s training testimonials to see feedback from prior session attendees.

Mock Audit Exercises and Coaching/Training

Although critical inspection logistics are a key element of preparing for an agency inspection, the readiness of a firm’s personnel is also crucial. Agency enforcers such as FDA investigators are well-trained to do thorough operational assessments by using specialized interview techniques. Therefore, the training of your firm’s subject matter experts (SME’s) also requires due attention in order to ensure the most positive outcome when your SME’s are subjected to FDA’s interrogation methods.

Some of your team members may be quite comfortable and effective dealing with the interrogation tactics employed by auditing Agencies like the FDA. But it’s not unusual for normal people to become afraid, unsure, frustrated, overzealous, and even angry when under such scrutiny. Such pressures can cause an otherwise reasonable person to provide inaccurate, incomplete, false, or too much information.

We’ve all heard the motto “practice makes perfect”. But at ComplianceAcuity, there is a new and improved motto:

“…PERFECT practice makes perfect…”

 

Proper practice is one the most significant factors affecting a firm’s readiness for an FDA or ISO audit. Accordingly, why not join the list of ComplianceAcuity Clients who have tackled their FDA inspections more prepared after ComplianceAcuity’s simulated FDA inspections and interviews of key personnel? ComplianceAcuity mock audits simulate relevant agency inspectional paradigms such as:

  • FDA Investigations Operations Manual (IOM)
  • Health Canada GD210
  • FDA Quality Systems Inspection Technique (QSIT)
  • FDA Field Management Directives (FMD) & CP 7382.845

As part of the mock audit, ComplianceAcuity provides sincere feedback and coaching to identify your strengths and weaknesses. This in turn allows supplemental plans for training and practice to be devised as needed.

Gap Assessments and Contingencies

Photo of a Gap

As a general rule, agencies like the FDA usually prefer to give firms a chance to take voluntary and prompt corrective action to resolve violations before initiating formal regulatory / enforcement actions.  So one of the most effective ways a regulated firm can minimize inspectional observations is to faithfully perform self-assessments followed by documented corrective actions as needed.

Accordingly, the time preceding an upcoming agency inspection provides a unique opportunity to demonstrate such self-monitoring.  It’s not surprise then that a prompt onsite QS/GMP evaluation by an independent expert like ComplianceAcuity is a typical course of action for pre-announced and unannounced inspection scenarios alike.

ComplianceAcuity gap assessments simulate relevant agency inspectional paradigms such as:

  • FDA Investigations Operations Manual (IOM)
  • Health Canada GD210
  • FDA Quality Systems Inspection Technique (QSIT)
  • FDA Field Management Directives (FMD) & CP 7382.845
Gears

Critical Logistics

Certain logistical arrangements are a crucial necessity during inspections by agencies like the FDA. In general, the heart of these arrangements involves the set-up, staffing, and management of the “front-room” and “back-room” that are used to manage the inspection. Our Clients have enjoyed improved inspectional outcomes from critical logistics overseen by ComplianceAcuity such as:

Front Room:

  • Staffing, arrangement, roles and responsibilities
  • Logging and tracking of Inspector requests
  • Real-time, strategic communication between the front-room and back-room

Back/”War” Room:

  • Staff roles and responsibilities
  • Receipt, tracking, and strategic processing of Inspector requests
  • Record-keeping and archives of inspectional events

 

Dynamic Pre-Closeout Interventions

One of the most important tactics to utilize during any Agency inspection is the prompt initiation and completion (where possible) of corrections and/or corrective actions in response to objections raised. When firms diligently seek daily status updates from the Inspector and then work to characterize and resolve the issues before the end of the inspection, it can motivate the auditor not to officially cite those issues. Therefore ComplianceAcuity is always diligent to identify and implement such solutions throughout your inspection by applying ComplianceAcuity’s proven remediation strategies. This reduces the burden of the ensuing remediation efforts, which can be significant.

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