Regulatory compliance consulting services

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Regulatory Compliance

Consulting Services

rob@13485cert.com

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

rob@13485cert.com

Inspection Room &Back Room

Back Room

Inspection Room

ScribeSME Managem

ent Rep

“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.

rob@13485cert.com

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

Clinicals

Effectiveness

Service

Mngt. Review

Internal Audits

VOC SurveysNCMR’s

Complaints

Validation

http://bit.ly/CAPA-Webinar

rob@13485cert.com

How to avoid “Death by CAPA”

Quality Issues

Quality Plan

Risk Analysis

Trend Analysis

Formal CAPA

We use a risk-based approach

We always initiate a CAPA

rob@13485cert.com

Pareto Analysis of Problems

rob@13485cert.com

Most Common 483s in FY2013

http://bit.ly/Form483-FY2013

http://bit.ly/Download-Pareto483s

rob@13485cert.com

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

rob@13485cert.com

Metrics &Quality Objectives?

Step 7

Process OutputsProcess InputsStep 2 Step 3

With Whom?Ste

Procedures & Forms?

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

rob@13485cert.com

Adjacent Link Auditing

Design Controls

Post-Market Surveillance

Risk Analysis – Input to Design Process

http://bit.ly/AdjacentLinkAuditing

Complaint HandlingSeveral Processes

CAPA &Management Review

rob@13485cert.com

Tools for Supplier Evaluation

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

rob@13485cert.com

“It’s not my fault.”

http://bit.ly/MyBoneZoneArticles

rob@13485cert.com

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

rob@13485cert.com

Do you need help with responding to a FDA

Rob Packard

rob@13485cert.com

+1.802.281.4381

rob13485

rob@13485cert.com

Glenn@MedicalDeviceAcademy.com

+1.561.308.3093

If you can’t reach me…

Regulatory compliance consulting services

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