we got a warning letter – now what? how to keep calm in a compliance storm

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Before We Start

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Brian Scogland Consultant II Halloran Consulting Group

Angela Brown Senior Consultant Halloran Consulting Group

Introducing the Featured Speakers

MODERATOR Brian Johnson Publisher Mass Device

FEATURED SPEAKER FEATURED SPEAKER

Proprietary & Confidential Proprietary & Confidential #MDOWebinar

Agenda

Intro to 483 & Warning Letter Remediation

Recent Warning Letter Language

Framework for Response

Framework for Remediation

Summary & Questions


Introduction •  Medical Device, Biotech, & Pharmaceutical

–  all impacted by 483s & warning letters

•  Discuss activities necessary to prepare response

to 483 observations or Warning Letter

•  Proven actions to help your team stay calm


Poll #1

Poll: Which type of organization are you from? –  Medical Device –  Biotechnology –  Pharmaceutical


Poll #2

Poll: Which Department are you from? –  Executive Management –  Regulatory Affairs –  Quality Affairs –  Operations –  Research & Development


Does this Sound Familiar? “This inspection revealed that these devices are adulterated…” “We acknowledge your commitment to updating your procedure. However, your response is inadequate…” “Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.” “Please notify this office in writing within 15 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.”

•  This could happen to you! –  Quality slips over time & remediation is a regular occurrence


Lead the response with calm & firm demeanor

•  Keeps Management Team supportive •  Shows management commitment to compliance •  Reflects well with the Agency interactions

Remain the Constant Calm


Poll #3

Poll: Have you ever or are you now working at a company operating under a Warning Letter?

–  Yes –  No


You Just got a Warning Letter - Now What?

•  Stay poised •  Rough order of activities to start the framework:

1.  Receive 483 Observation(s) or Warning Letter 2.  Preparation 3.  Response 4.  Review 5.  Submission 6.  Remediation


Whether a 483 or warning letter response, many activities are the same

•  Timeline: 15 business days •  Comprehensive response •  Project plans with due dates •  Monthly status updates •  Internal & external review of response •  Re-establishing FDA’s confidence

Response Overview


Where do we start with a response? •  Immediately meet with Executive Management

–  Review scope of 483 Observation(s) or Warning Letter –  Obtain support for priority, resources, etc.

•  Meet with functional heads affected –  Assign resources –  Take response ownership in the response

•  Ensure: –  Appropriate staffing –  Materials, expertise, equipment –  Proper legal representation


The day after the investigator leaves

•  Reserve work space for meetings & response activities

•  Gather materials (paper, binders, printers, etc.) •  Identify teams (your “go-getters”) •  Plan meetings •  Prep counsel for reviewing response

Preparation for the Response


Crafting the Response

•  Ensure timely response! •  Empower functional heads •  Determine root causes •  Generate significant progress in each area in question •  Provide objective evidence •  Document Corrective Actions

–  Include timelines

Important! Failure to demonstrate proof behind any of your stated corrections will lead to more compliance risk – i.e. non-

acceptance, possible additional regulatory action (Warning Letter, Consent Decree)


Remediation – What to Expect

•  Expensive and often large projects –  6 months to a year+

•  Drag on business initiatives & development projects •  Loss of resources

•  Opportunity to shine!! –  FDA, Management, and Staff

•  Demonstrate leadership attributes


Remediation – First Steps

The day after the response is sent •  Are you staffed to deliver the remediation?

–  Meet with Executive Management, HR –  Strong Project Managers

•  Focus on resources is in place vs. what is needed –  Expertise may be lacking in-house –  Consider outside resources

•  Do you need to retain key individuals?


Remediation Process

•  Formally launch a project with Workstreams and Workstream Leads

•  Create Project plan with intermediate and final deadlines

•  Track progress religiously

•  Meet frequently


•  Increased scrutiny from other regulatory agencies

•  Potential limitations to distribution channels

•  Marketplace disruption

Additional Impacts from a Warning Letter


Response •  Remain calm •  Plan out your initial timeline: 15 Days •  Well thought out & comprehensive response

Remediation •  Prepare for long term •  Resourcing critical •  Strong leadership

Summary

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Questions?

Brian Scogland Consultant II Halloran Consulting Group [email protected] @scogs30

Angela Brown Senior Consultant Halloran Consulting Group [email protected]

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we got a warning letter – now what? how to keep calm in a compliance storm

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