Regulatory compliance consulting services

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Rob Packard, Presidentwww.MedicalDeviceAcademy.com

[email protected]

Regulatory Compliance

Consulting Services

http://www.medicaldeviceacademy.com/

mailto:[email protected]

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[email protected]

How to Prepare for YourNext FDA Inspection

http://bit.ly/FDA30min

Don’t act like the Keystone Kops. Click on this link if you want to know what to do during the first 30 minutes of an FDA inspector’s arrival.

http://bit.ly/FDA-Inspection-Webinar







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[email protected]

Inspection Room &Back Room

Back Room

Inspection Room

ScribeSME Managem

ent Rep

FDA

“DrillSergeant”

Printer / Copier

FoodFridge

SMEOn-Deck

Runner

Phones & Computers are critical for communication between rooms, the rest of company and other locations/suppliers

Speaker Phone

Projector

Projectors help the “Drill Sergeant” communicate to the rest of the back room without the team looking over their shoulder at a laptop screen

R&DProduct Mngr.



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Auditor’s View of CAPAsCAPAs are the heart of a Quality Management System (QMS) and tell inspectors how effective the QMS is.

CAPA’s

Risk Analysis

MAUDE

Clinicals

Effectiveness

Service

Mngt. Review

Internal Audits

VOC SurveysNCMR’s

Complaints

Validation

http://bit.ly/CAPA-Webinar






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How to avoid “Death by CAPA”

CAPA

CAPA

Quality Issues

Quality Plan

Risk Analysis

Trend Analysis

Formal CAPA

We use a risk-based approach

We always initiate a CAPA



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Pareto Analysis of Problems



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Most Common 483s in FY2013

http://bit.ly/Form483-FY2013

http://bit.ly/Download-Pareto483s







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Complaint handling should…

• Capture all complaints• Include time limits for investigation and

reporting decisions• Extend the investigation to other potentially

affected product• Document reason for no investigation• Document reason for no corrective action

http://bit.ly/Complaint-Webinar-Landing





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Metrics &Quality Objectives?

Step 7

Process OutputsProcess InputsStep 2 Step 3

With Whom?Ste

p 5

Procedures & Forms?

Step

6

With What EquipmentFacilities & Materials?

Step 4

Step 1: Describe the Process & Identify the

Process Owner

Process Approach to AuditingA.K.A. – Turtle Diagrams

http://bit.ly/Process-Approach





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Adjacent Link Auditing

Design Controls

Post-Market Surveillance

Risk Analysis – Input to Design Process

http://bit.ly/AdjacentLinkAuditing

Complaint HandlingSeveral Processes

CAPA &Management Review



http://bit.ly/AdjacentLinkAuditing

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Tools for Supplier Evaluation

http://bit.ly/Supplier-Qualification-Webinar





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“It’s not my fault.”

http://bit.ly/MyBoneZoneArticles





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What’s the real root cause?

• Ineffective training with regard to 21 CFR 820– And 21 CFR 803– And 21 CFR 806

• Webinar Title: “21 CFR 820 Compliance”– 90-minute recording & 52-slide deck = $129– 20-question exam & training certificate = $49– FDA Leaving without an observation = Priceless

http://bit.ly/QA-RA-Webinars



http://bit.ly/QA-RA-Webinars

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[email protected]

Do you need help with responding to a FDA

483?

Rob Packard

[email protected]

+1.802.281.4381

rob13485



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[email protected]

[email protected]

+1.561.308.3093

If you can’t reach me…



Health & Medicine

Regulatory compliance consulting services