Presented by:

Kara Lee McWatters, Director, Quality Assurance, Stiris ResearchLisa Cevasco, Director, Quality Assurance, SDC

August 27, 2019

Quality Assurance for Clinical Operations: Stress-Reducing Tips for a Successful

Regulatory Inspection

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Kara Lee McWattersDirector, Quality Assurance at Stiris Research

• 27 years in industry• RQAP-GCP Certified Auditor• Managed National and Global Clinical Programs

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OncologyImmunologyTransplant

NeurologyCardiovascularDermatology

Lisa CevascoDirector, Quality Assurance at SDC

• 13 years in industry• Regular FDA and international regulatory

body interactions• Experience with responses to inspection

findings

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Agenda

What Types of Inspections the FDA, Health Canada, and EMA Perform

Typical Conduct for Regulatory Inspections

Inspection Readiness Tips

Common Findings and Pitfalls to Avoid

Q&A

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What Types of Inspections the FDA, Health Canada, and EMA Perform

• Pre-approval• Post-approval• Compliance Follow-Up• For Cause

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Protect the rights, safety and well-being of human research

subjects

Assure the quality, reliability and integrity of the data

collected

The ‘Why’?

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Types of Inspections

• Trigger: Application to market a new product• Domestic and Foreign• Usually announced• Who?

Sponsors (pharma/biotech) and CROs Investigational sitesLaboratories, third-party service providers IRBs (ethics committees)

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Pre-Approval Inspections

Types of Inspections

• Main focus on manufacturer: GMP, device• Assess continuing compliance• Changes in manufacturing and process control• Non-GMP: safety reporting requirements being met

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Post-Approval Inspections

Types of Inspections

• Review actions taken in response to a previous inspection• Usually unannounced

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Compliance Follow-Up Inspections

Types of Inspections

• Unannounced• Investigate a specific problem• Who: health care provider, consumer, employee

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For Cause Inspections

Who Gets Inspected?

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CI62%

B EQ17%

IR B11%

Sponsor/ CR O10%

US FDA BIMO1622 INSPECTIONS

Clinical140

Clinical40

PV20

PV80

EM A/ NCAs He a l t h Canada

EMA/NCAS & HEALTH CANADA

FDA 2018 Metrics: https://www.fda.gov/media/127110/downloadEMA 2018 Metrics : https://www.ema.europa.eu/en/documents/annual-report/2018-annual-report-european-medicines-agency_en.pdfHealth Canada Inspection Database: http://www.healthycanadians.gc.ca/apps/gcp-bpc/searchResult-en.html?lang=en&sponName=&contNum=&region=&drugName=&phase=&startDate=&rating=&cat=1

The Moral of the Story?

Be Inspection Ready!

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Typical Conduct of a Regulatory Inspection

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Greet the Inspector, Check ID & Credentials

Escort Inspector(s) to Appropriate Room

Upon Arrival

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Notify Employees and Applicable Parties

During the Inspection

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Back RoomFront Room

During the Inspection

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• Be professional at all times; limit small talk

• Exchange business cards• Provide lunch, water, snacks• Escort inspector(s) per SOPs• Ask for clarification as needed• Only answer what they ask; do

not fill gaps of silence

Front Room

During the Inspection

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• Ask for clarification as needed• Share background on documents

prior to sending to front room• Stamp all confidential documentation• Maintain list of materials provided• Limit conversations in public areas• Keep employees notified

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Back Room

After the Inspection

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Await Regulatory Authority Report

Review Lessons Learned

Celebrate!

Inspection Readiness Tips

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Top 10 Inspection Readiness Tips

1. Develop SOP on regulatory inspections2. Conduct regular internal audits3. Ensure project documentation is up-to-date and readily available4. Maintain library of SOPs including retired versions5. Ensure proper technology support (printers, USB)6. Carefully select front room location7. Conduct mock inspection with external consultant8. Conduct inspection readiness training with staff9. Stay current on industry activities related to your projects10. Be aware of regulations and guidelines from inspection agencies

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Common Findings and Pitfalls to Avoid

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Inspection Outcomes

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CI/ Sponsor/Sites CRO

OAI 1% 4%VAI 27% 22%NAI 72% 74%

FDA

Critical 7%Major 49%Minor 44%

EMA/NCAs

Non-Compliant 8%Compliant 92%

Health Canada

FDA 2018 Metrics: https://www.fda.gov/media/127110/downloadEMA 2018 Metrics : https://www.ema.europa.eu/en/documents/annual-report/2018-annual-report-european-medicines-agency_en.pdfHealth Canada Inspection Database: http://www.healthycanadians.gc.ca/apps/gcp-bpc/searchResult-en.html?lang=en&sponName=&contNum=&region=&drugName=&phase=&startDate=&rating=&cat=1

Common Findings

• Protocol Compliance• Sponsor Oversight• Investigator Oversight• Informed Consent• Records• Quality System• Calibration and Maintenance

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Key Takeaways

Be Inspection Ready!SOPsSystems documentation Internal quality control and auditsSituational awareness

Tools for Inspection Readiness

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FDABIMO Website

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-

investigations/compliance-program-guidance-manual-cpgm/bioresearch-monitoring-program-bimo-compliance-programs

EMA/NCAsCompliance Website

https://www.ema.europa.eu/en/human-regulatory/research-

development/compliance/good-clinical-practice/inspections-procedure

Health CanadaGCP Website

https://www.ctg.queensu.ca/docs/public/misc/GCPpre-inspection.v1_en.pdf

“Spectacular achievement is always preceded by unspectacular preparation.”

-Robert H. Schuller

Questions?

Thank You!

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data@sdcclinical.comwww.sdcclinical.com

auditing@stirisresearch.comwww.stirisresearch.com