The FDA Regulatory and Compliance Symposium Preparing for the FDA’s Risk-Based Inspections...

The FDA Regulatory and Compliance Symposium

Preparing for the FDA’s Risk-Based Inspections

Presented By: Martin Browning, EduQuest, Inc.

www.EduQuest.Net

© 2005 EduQuest, Inc.

Preparing for the FDA’s Risk-Based Inspections – Agenda

• A little history

• Current driving forces

• FDA “risk” initiatives

• Inspectional process changes

• Preparation


Risk and FDA

• Response to catastrophe (or perceived catastrophe)

• Patients and users

• Influence of the Medical Device cGMP regulation

• Product risk

• Process risk

• Influence of harmonization issues


Risk and FDA

• Safety Net– Gatekeeper– Inspections– Self reporting

• Risk-benefit– Time-to-market and availability to patients– Post-market studies


Risk and FDA

• Loss of the little “c” (e.g. cGMP)– Scope growth (Foods and Drugs to Foods, Drugs,

Cosmetics, Devices, Biological Products, Radiation Emitting Products, Terrorism,…)

– Technology explosion (Computer and Software driven)

– Lack of competitiveness in hiring and loss of competitiveness in retaining

– Rigidity

– Response of the regulated industries


Current Driving Forces

• Medical mistakes

• Food/Drug/Supplement/etc. interactions

• The Generic Drug Scandal

• Criticisms of approvals

• “Partnering with Industry”

• Pharmaceutical promotion


Current Driving Forces

• FDA funding by “User Fees”

• Prescription drug costs in the US

• FDA stance on “re-importation”

• The politicizing of the FDA

• Incredibly low Agency Funding

• Low Agency morale


The Agency Response

• Do more with less and less– Resulted in doing less with less

• Rebuild the “Science Base” of the Agency– Increased use of “outside” scientists

• Turn to technology– Pray for Process Analytic Technology

• Focus resources on “risk”


FDA “Risk” Initiatives

• Internal Initiatives– Focus on internal systems– Schedule inspections based on risk

• Premarket Initiatives– More meaningful data– More automation in submissions– More electronic analysis– Speedier approvals


FDA “Risk” Initiatives

• Other Initiatives– “Science” based approaches– PAT (Process Analytic Technology)– Reinterpretation of Part 11– Centralizing Warning Letter Review– Inspectional process changes– Etc.


Inspectional Process Changes

• Choosing whom to inspect

• The Investigator

• Smoothing of the reporting process

• Focus of the inspection

• Increased dangers



• Some of you should prepare for more frequent inspections based upon– Complaints, AERs, MDRs

– Known product complexity

– Known manufacturing process complexity

– Life sustaining/supporting status

– Inspectional history (recalls, 483s, Warning Letters, etc.)

• Improve your “score” on FDA’s “rating system”



• The Investigator– “Pharmaceutical Inspectorate” (Team Biologics,

National Experts, etc.)– Increased use of District or Regional inspection teams– Increased specialization

• Smoothing of the reporting process– “Turbo – 483”, “Turbo – EIR” (revisions, I hope)– Slightly improved data systems



• Focus on “Systems”– FDA believes “Quality Systems” map clearly to all

cGMP regulations – understand how the “map” applies to you

– Keep up with FDA guidance, compliance programs, legal actions, and monitor Agency presentations

– Understand the “QSIT” model, and the regulatory approach used in the Medical Device cGMPs



• Focus on “Systems”– Have a quality system and all subsystems, document

them, use them, and have evidence of their use– Prepare for “bottom-up” inspections beginning with

complaints, OOS results, failure investigations, AERs, MDRs, non-conformances, process deviations, etc. The causes of these events should be included in (or be added to) your established patient, product, and process risks



• Focus on “Systems”– Pay special attention to the “Management Controls”

subsystem and its effectiveness– FDA expects quality control, quality assurance, and

quality oversight processes – assure that these processes work and their effectiveness is communicated to “management with executive responsibility”



• Focus on “Risk”– Patient Risk– Product Risk– Process Risk– Have formal methodologies for risk management

appropriate for your products (e.g. FMEA, FMECA, FTA, HACCP)



• Focus on “Risk”– Map and understand your processes identifying

specifications, control points, critical control points, process monitoring, and risk mitigations

– Build new processes based on science– Rebuild existing processes– Validate processes, treating validation as a life-cycle

process



• Increased Dangers– Fewer “bites-at-the-apple”– More centralized FDA coordination/communication– “Bottom-up” approaches can lead to erroneous

conclusions– Some will look at FDA’s initiatives as excuses not to

comply with regulations – this would be a critical mistake

The FDA Regulatory and Compliance Symposium Preparing for the FDA’s Risk-Based Inspections...

Documents

Transcript of The FDA Regulatory and Compliance Symposium Preparing for the FDA’s Risk-Based Inspections...