TRAINING ON FDA INSPECTIONS FOR CATALYTICA...•Headquarters Reviewer 3 . 7 SUBSYSTEMS OF THE...
Transcript of TRAINING ON FDA INSPECTIONS FOR CATALYTICA...•Headquarters Reviewer 3 . 7 SUBSYSTEMS OF THE...
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P R E P A R I N G F O R A N F D A
I N S P E C T I O N
A D A P T E D B Y L E O J . L A G R O T T E F R O M P E R S O N A L E X P E R I E N C E , P R E S E N T A T I O N S & B Y O T H E R F O R M E R
F D A I N V E S T I G A T O R S .
Florida Medical
Manufacturers Consortium
May 14, 2018
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WHY DO WE NEED A SUCCESSFUL INSPECTION?
• Prevent Regulatory action
• Ensures consumer safety
• Your professional reputation
• Freedom from legal problems
• Verify our continuous improvement process
• Increased Customer Response via Sales
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WHO’S ON THE INSPECTION TEAM?
• All QA/RA
• Engineers/Chemists
• Investigators
• Microbiologists
• Computer Specialist
• Headquarters Reviewer
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7 SUBSYSTEMS OF THE QUALITY SYSTEM
Material Controls
Records/
Documents/
Change Controls
Design Controls
MANAGEMENT
Corrective
&
Preventive Actions
Production
&
Process Controls
Facility
&
Equipment Controls
Sterilization
Process
Controls
Medical Device
Tracking
Reports of Corrections and
Removals Medical Device
Reporting
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WHAT WILL THEY LOOK AT? DEPENDS ON THEIR ASSIGNMENT!
• Complaints/Service/CAPAs/NCRs
• Computers/Software/eMDR
• QM, Procedures and Work Instructions
• Rejected batches
• Validation and Sterile Processes
• Overall facility
• Buildings, equipment, materials, cleaning procedures, HVAC, etc.
• Design Controls and Especially Risk Management
• New High Risk Devices, 510(k), Change Controls
• Labels and Packaging, Are you GUDID Compliant
• Components and Nonconformances reported in
• In-process materials and systems
• Validation processes including Sterilization
• Final Release Activities
• Logbooks, records and documents
• Areas not looked at before-Be Ready
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WHAT SHOULD YOUR COMPANY BE DOING PRIOR TO THE INSPECTION ?
• Review all new designs; design changes and major NC since last inspection.
• Review your performance since last inspection (Internal Audits and CA).
• Provide continuing verifiable cGMP training to all employees.
• Taking broad steps to communicate the importance of the expected FDA inspection to all management and employees.
• Ensure Resources are available to review QS to ensure regulatory compliance. (continual)
• Identifying inspection coordinators.
• Developing an inspection response plan.
• Establishing communication procedures.
• Designating key personnel responsibilities.
• Establishing written policies-photos; recordings; etc.
• Enhancing your continuous improvement process.
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WHAT SHOULD I DO PRIOR TO THE INSPECTION?
• Support preparation efforts. • Ensure your work area is neat and orderly. • Ensure your area equipment and instruments are
clean and calibrated. • Ensure your logs and production documents are
filled out completely, accurately and legibly at time of performance.
• Be prepared. • Know your job. • Encourage your fellow workers. • Expect high quality in all your work-accept
nothing less. • Remember: First impressions are lasting
Impressions; Employees, facilities and high quality documents make a lasting impression with the FDA! 7
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WHAT CAN I DO DURING THE INSPECTION?
• Listen carefully to questions.
• Don’t assume you know the question.
• Answer only after the question is fully stated.
• Be confident of your answer. If you don’t know, say so.
• Avoid bragging about your area.
• Don’t be nervous.
• Re-review all your procedures.
• Provide only what is asked for.
• Don’t leave documents out on your desk.
• Keep your area clean. Be ready any day!
• Be proud of your area but the best of things are left
unseen.
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HOW DO I ANSWER AN INVESTIGATOR’S QUESTIONS? • Do’s
• Don’ts
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DO
• Be prepared. • Be professional. • Provide documents in a timely fashion. • Answer questions directly and honestly. • Recognize“ I Don’t Know” is an acceptable
answer.
Don’t • Guess or estimate. • Volunteer information. • Provide any misinformation. • Provide misleading information. • Show temper or be argumentative 10
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R E S P O N D I N G T O
T H E F O R M F D A - 4 8 3
Florida Medical
Manufacturers Consortium
May 14, 2018
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7 STEPS TO RESPOND TO FDA 483 INSPECTIONAL OBSERVATIONS
• Respond to the FDA 483 violation(s) in less than 15 business days
– Use New Electronic Format to Appropriate Compliance Division
• Use your CAPA forms instead of a memo
– First Page prepare a Cover Letter backed by all CAPAs and Corrective Actions
• Document the investigation and root cause
• Don’t forget containment and correction
– If a market withdrawal or Recall is planned, demonstrate containment of affected
product before end of inspection with plan to continue if completed.
• Explain the corrective action plans and timelines
– Send all documents corrected, SOPs, Work Instructions, Training Records
• Show the FDA you have already taken action
– Demonstrate initiation of CAPAs or Document corrections before end of inspection
• Follow-up before the FDA does
– At a minimum every 30 days or as corrective actions are completed
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NEW FDA CONTACT INFORMATION
Florida is under the new reorganization of Office of Regulatory Affairs Office of Medical Devices and Radiological Health Operations (OMDRHO) Division 2 – Central
555 Winderley Place, Suite #200
Maitland, FL 32751
Area Under Division 2- AL; FL; GA; IA; IL; KS; LA; MN; MO; MS; NC; ND; NE; SC; SD; TN; WI; Puerto Rico and Virgin Islands
Send all correspondence via email: [email protected]
Label all attachments and keep each file less than 100MB. If greater send multiple emails
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THANK YOU
DISCUSSION & QUESTIONS
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Leo J. Lagrotte Senior Consultant [email protected] 941-920-2645
www.qss-llc.com