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Leadership For The FDA Inspection   The Manager Review
 

Leadership For The FDA Inspection The Manager Review

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A leadership primer, and project plan, for an impending inspection by the FDA.

A leadership primer, and project plan, for an impending inspection by the FDA.

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    Leadership For The FDA Inspection   The Manager Review Leadership For The FDA Inspection The Manager Review Presentation Transcript

    • Our Leadership for an FDA Inspection: The Managers’ Review Adapted by Mitchell W. Manning Sr. from presentations by former FDA Investigators.
    • Agenda 1. Introduction to the FDA Inspection 2. Our Leadership of the FDA Inspection 3. Experiences from Inspections 4. Critical cGMP elements 5. Job performance - scenarios and role plays 6. Review/Wrap-Up/Questions
    • 1. Introduction to the FDA Inspection
      • A. Types of Inspections
      • B. All about cGMP (Current Good Manufacturing Practice)
      • C. How we get into trouble
      • D. The need for a successful inspection
      • E. FDA actions - if we don’t have a successful inspection
      • F. The FDA’s Inspection Team
    • 1. Introduction to the FDA Inspection A. Types of Inspections
      • 1. Pre-approval
      • 2. Post-approval
      • 3. Follow up to Warning Letter, etc.
      • 4. “For Cause”, recall, complaint, special program, ADR follow-up, etc.
      • Introduction to the FDA Inspection B. All about cGMP
      • 1. Requirement of job and our industry
      • 2. Valuable aid to provide properly documented and accurate records
      • 3. Protects the company
      • 4. CGMPs are the law (21 CFR Parts 210 &211)
      • 5. Protects the consumer
      • 6. Protects our professional integrity
      • 7. Protects our profitability
    • 1. Introduction to the FDA Inspection C. How we get into trouble
      • Complacency!
      • 1. Good last inspection
      • 2. Reduce those non-productive quality folk
      • 3. Still runs-why fix or replace
      • 4. Maintenance costs on the bottom line
      • 5. Customer want products first and foremost
      • 6. Protect bonuses at all cost
      • 7. Meet revenue targets
      • Look at the effects of complacency
    • 1. Introduction to the FDA Inspection D. The need for a successful inspection
      • 1. Approvals / Contracts
      • 2. Freedom from legal problems
      • 3. Our reputation(s)
      • 4. Stockholder market issues
      • 5. Stakeholders
      • 6. Insures consumer safety!
    • 1. Introduction to the FDA Inspection D. The need for a successful inspection cont’d
      • 7. Company hit with FDA sanctions
      • 8. Jobs are lost
      • 9. Tremendous resources are expended to correct the problems.
      • 10. We may loose our opportunity to work
      • 11. Law suits
      • 12. Company stock falls in value
      • 13. Loss of professional integrity
    • 1. Introduction to the FDA Inspection E. FDA Actions – if we don’t have a successful inspection
      • 1. Warning Letters
      • 2. Seizures
      • 3. Injunctions
      • 4. Prosecutions
      • 5. Withholding approval
      • 6. Detentions
      • 7. Invoke Application Integrity Policy (AIP)
    • 1. Introduction to the FDA Inspection F. The FDA’s Inspection Team
      • 1. Investigators
      • 2. Microbiologists
      • 3. Chemists
      • 4. Engineers
      • 5. Computer Specialist
      • 6. Headquarters Reviewer *
      • 7. US Attorney *
      • * Note: off site but involved
    • 2. Our Leadership for the FDA Inspection
      • A. Our Team
      • 1. Project Management
      • 2. Production
      • 3. Quality Operations
      • 4. Engineering
    • 2. Our Leadership for the FDA Inspection
      • B. Key Roles and Number of People
      • 1. Hosts/4
      • 2. Scribes/4
      • 3. Runners/4
      • 4. Key Divisional Contacts/8
      • 5. Document Room/4
      • 6. Situation Room/6+
    • 2. Our Leadership for the FDA Inspection
      • C. Instructions to Key Contacts
      • 1. When paged by 9999
      • 1. Immediately call the Situation Room
      • 2. You will receive specific instructions
      • 3. Follow the instructions immediately
      • 2. During the Inspection
      • 1. Notify the Situation Room prior to any absence from site during business hours
      • Our Leadership for the FDA Inspection D. When the FDA comes calling
      • 1. There is a written receiving procedure
      • 2. Insure security and sign-in are followed
      • 3. Establish, train, and follow alert system
      • 4. Notice of Inspection given to senior executive
      • 5. Keep FDA advised on any delays
      • 6. Inquire about the scope
      • 7. Ask to read the assignment letter
      • 8. Offer short presentation (optional)
    • 2. Our Leadership for the FDA Inspection E. Readiness Plan
      • 1. Daily start-up and end of day meetings
      • 2. Who issues the daily summary report?
      • 3. Management evening action sessions?
      • 4. Who plans to receive the FDA 483?
      • 5. Who signs the FDA 483 response?
      • Our Leadership for the FDA Inspection F. Readiness Check
      • 1. Personnel training
      • 2. Selection of personnel:
        • To accompany investigators
        • Key personnel to provide data, etc.
        • Need to cover the FDA inspection team
      • 3. Inspection management plan
      • 4. Purpose of Readiness Check
      • 1. Evaluate readiness for FDA inspection
      • 2. Identify system weaknesses
      • 3. Provide opportunity for corrective action
      • 4. Identify key personnel presenters, subject
      • matter experts and backups
      • 5. Provide an opportunity to critique and/or
      • change presenters
      • 6. Identify and train coordinators—escorts,
      • runners and scribes
      2. Our Leadership for the FDA Inspection F. Readiness Check contd
      • Our Leadership for the FDA Inspection F.. Readiness Check contd
      • 4. Purpose of Readiness Checks cont’d
      • 7. Provide staff training
      • 8. Refresh staff knowledge of company policies
      • 9. Provide more effective communications
      • 10. Develop an experience base of Do’s and
      • Don’ts for entire staff
      • 11. Determine availability of documents
        • A. Can all appropriate documents be found?
        • B. Practice forwarding in a timely manner.
      • 12. Provide experience in document handling
      • 1. Provide re-training when necessary
      • 2. Correct identified system weaknesses
      • 3. Verify corrections with spot audits
      • 4. Maintain high awareness level of staff
      2. Our Leadership for the FDA Inspection G. Follow Up to Readiness Checks
    • 2. Our Leadership for the FDA Inspection H. Where will the FDA look?
      • 1. Examination of buildings, equipment and materials, cleaning
      • procedures, HVAC, etc.
      • 2. Facility tour is normally first
      • 3. Reviewing rejected batches
      • 4. May have complaints to follow-up
      • 5. Review of documents
        • a. Production records
        • b. Laboratory records
        • c. Logs/charts
        • d. Written procedures (SOPs)
      • 6. Sampling procedures
        • a. In-process materials
        • b. Finished released materials
        • c. Components
        • d. Labeling
        • e. Validation
    • 2. Our Leadership for the FDA Inspection I. Current Status and Next Steps
      • 1. Plan in place (FDA inspection procedure)
      • 2. Coordinators identified
      • 3. Key personnel available
      • 4. Designated responsibilities
      • 5. Communications
      • 6. Policies established in writing (Photos; recordings; etc.)
      • 7. Key management positions and changes
      • 8. Major changes in systems or facility since prior inspection
      • 9. Commitment of the company to comply
      • 10. Cover relevant company policy
      • 11. Introduce escorts & key personnel
      • 12. Set a positive tone for the inspection
    • 2. Our Leadership for the FDA Inspection I. Current Status and Next Steps cont’d
      • 13. Specify the FDA on-site office
      • 14. Listing of documents requested and copies for firm
      • 15. Summary of Q&As
      • 16. Daily review of findings
      • 17. Office space
      • 18. Escorts identified
      • 19. FDA investigators should be encouraged to discuss observations as they are made with management to minimize surprises/arguments when the FDA-483 is issued.
      • 20. How to say no
      • 21. Know the answer to every question
      • 22. Be responsive to FDA requests
    • 2. Our Leadership for the FDA Inspection J. Our Assessment Process
      • 1. Inspection project monitor assigned
      • 2. Document the major findings
      • 3. Insure accurate records on the daily FDA debriefing
      • 4. Keep up with FDA requests vs. corrective actions
      • 5. Follow up on items due FDA
    • 3. Experiences from other inspections.
      • Do’s
      • Don’ts
      • Possible scenarios
      • Experiences A. Do’s
      • Answer questions honestly
      • Answer questions directly
      • “ I Don’t Know” is acceptable
      • Provide documents timely
      • Be professional
      • Be prepared
      • Leave room if FDA asks for verbal ok
    • 3. Experiences A. Do’s (continued)
      • Communicate with the investigator
      • Project a positive,confident attitude
      • Police your area
      • Go over the Readiness plan with your reports
      • Insure re-reading of SOP and procedures
    • 3. Experiences B. Don’ts
      • Volunteer information
      • Guess or estimate
      • Provide any misinformation
      • Provide misleading information
      • Leave Investigator(s) alone
      • Show temper or be argumentative
      • Sign any statement, unless it is policy to do so
    • 3. Experiences B. Don’ts (continued)
      • Blame the Investigator or local Office
      • Talk about: FDA approved-product,process or plant. FDA approves applications, certifies acceptable level of compliance etc.
      • Talk negative about how the last investigator’s appearance or behavior
      • Make negative comment about your fellow worker or the company.
    • 3. Experiences C. Possible scenario
      • Many investigators appear to ramble and be non-specific with questions or comments.
        • Be careful. Sometimes they are fishing and hoping you will guess what they are asking. This can reveal clues to them that can lead to a fishing expedition.
    • 3. Experience C. Possible Scenarios
      • Loose notes on desks, information left on chalk board, scrap paper, etc.
        • Instruct people so there are none of these left in their areas.
        • A requirement to shred all discarded paper is a good rule.
        • Situations have occurred where FDA found damaging company information left out in the open.
    • 3. Experiences C. Possible scenarios
      • These Questions might get you into trouble.
        • Asking about a related area you are familiar with.
        • You answer one question, then another. Soon you get to where you are no longer sure.
        • STOP!
        • Suggest that the FDA get specific information from the area expert; offer to bring the expert to FDA.
    • 3. Experiences C. Possible scenario
      • Avoid being robotic in answering FDA questions.
        • Don’t volunteer any damaging or leading information.
        • Honestly and completely answer their questions.
        • Be calm. Maintain a confident,attentive and responsive attitude throughout the inspection.
    • 3. Experience C. Possible scenario
      • Avoid providing more than is asked for.
        • If training information is requested for a specific task, for a specific employee, don’t provide the full training file.
        • Clarify exactly what is wanted and provide it in a timely manner.
    • 3. Experience C. Possible scenario
      • It is ok to answer general questions about another area.
        • Do it in a way that your answer leaves the investigator with the understanding that if he or she want’s a final answer he/she will need to talk to the area expert.
        • Say, “ As I recall” or “Based on my recollection” followed by, “Let’s talk to. . .”
    • 4. Critical cGMP Elements
      • Write procedures
      • Follow your procedures
      • Document/record work
      • Validate work
      • Design and build proper facilities
    • 4. Critical cGMP elements cont’d
      • Maintain the facilities and equipment
      • You must know your job
      • Train to maintain excellence
      • Be clean
      • Control for quality
      • Audit for compliance
    • 5. Job Performance – Scenarios and Role Plays
      • Evidence of a stability failure is found by the Investigator.
      • What are you going to say to FDA?
      • The FDA Investigator appears confrontational.
      • What are you going to say and do?
      5. Job Performance – Scenarios and Role Plays
      • The investigator makes a leading statement about noncompliance with eye contact, and then there is a long awkward pause.
      • What are you going to say and do?
      5. Job Performance – Scenarios and Role Plays
      • FDA: What are they doing?
      • Potential Answers
        • I don’t know. I will check with the operator
        • Making a batch of cold tablets
      5. Job Performance – Scenarios and Role Plays
      • FDA: How does Joe know how to do that?
      • Potential Answers:
        • I am sure Joe was trained. Let’s ask him.
        • Our company policy requires that all employees are trained on the process prior to their assignment. Joe also has considerable experience on the job
      5. Job Performance – Scenarios and Role Plays
      • FDA: Where is the procedure for the job this operator is doing?
      • Potential Answers:
        • I am sure they are around. I will find out later and get back on that.
        • Official procedures are available in the area of use. Our employees are expected to follow the official procedure.
      5. Job Performance – Scenarios and Role Plays
      • FDA: Is that the latest procedure?
      • Potential Answers:
        • Yes, only the current procedure is available for use.
        • This should be the latest issue. Lets go to central data and verify.
      5. Job Performance – Scenarios and Role Plays
      • FDA: When was Bill trained?
      • Potential Answers:
        • I don’t recall the exact date when when Bill first came on the job but our policy is to train on a job before the employee conducts cGMP work. Also we conduct periodic re-training.
        • Bill came to work about 10 years ago so I know he was trained then. Let’s go to the training files and check on the date.
      5. Job Performance – Scenarios and Role Plays
      • FDA: This procedure has been revised, were you trained on the revisions?
      • Potential Answers:
        • Yes, we are required to conduct a formal training session on the revisions prior to implementing.
        • The area supervisor keeps up with training. I think I will defer your question to that person. I do know a lot of training goes on every Thursday evening.
      5. Job Performance – Scenarios and Role Plays
      • Why Challenge ourselves with Role Playing?
      • Planning vs Implementation
      • Exercising your brain
      • Experience leads to wisdom
      • A picture/experience is worth……….
      5. Job Performance – Scenarios and Role Plays
      • From past inspection experience give us a . . . . . . .
      • “ HEAVENLY” situation
      5. Job Performance – Scenarios and Role Plays
      • From past inspection experience give us a . . . . . . .
      • “ situation straight from H!!!”
      5. Job Performance – Scenarios and Role Plays
      • How do you take the blood off the question mark ?
      • EXERCISE
      5. Job Performance – Scenarios and Role Plays
      • FDA finds a thermometer in the laboratory that has not been calibrated.
      • What do you say and do?
      5. Job Performance – Scenarios and Role Plays
      • Upon reviewing the label room, inserts and labels are found which do not have any status label.
      • What are you going to do and say?
      5. Job Performance – Scenarios and Role Plays
      • There is a temperature excursion showing on the daily chart recordings for the stability chamber.
      • What are you going to do and say?
      5. Job Performance – Scenarios and Role Plays
    • 5. Job Performance – Role Plays and Scenarios
      • A. Discarding original data
      • B. OOS Investigation
      • C. First Impressions
    • A. Discarding original data
      • 1. Using cheat sheets, sticky sheets, or paper scraps is a common practice for recording some preliminary data.
      • 2. This is a destruction of original data when you discard that scrap paper.
      • 3. Also, your data becomes non-original
      5. Job Performance – Scenarios and Role Plays
    • B. OOS Investigations
      • 1. Failure to have an adequate written procedure and follow it can spell trouble.
      • 2. Many errors are assigned a cause based on a theoretical possibility of a solution.
      • 3. This is wrong.
      • 4. A full expanded investigation must be made if the assignable cause is not identified.
      • 5. In some cases, circumstantial evidence can be enough.
      5. Job Performance – Scenarios and Role Plays
    • B. OOS Investigations
      • Prepare by reviewing and collecting appropriate documents
        • Batch records
        • Associated laboratory records
        • Investigation reports
        • Non-conforming materials reports
        • OOS reports
      5. Job Performance – Scenarios and Role Plays
    • C. First impressions
      • During a visit to a firm in Cincinnati, Ohio the owner hardly spoke to me.
      • He said go on and inspect, never moving from behind his desk.
      • I proceeded to gather a strong case of violations and when done I presented a shocked owner with a very negative report.
      5. Job Performance – Scenarios and Role Plays
    • First Impressions are Lasting Impressions
      • 1. Employees facilities and documents make a lasting impression with the FDA investigator
      • 2. Frequent employee meetings
      • 3. What to expect
      • 4. Know your job
      • 5. Be prepared!
      • Job Performance – Scenarios and Role Plays
      • In Conclusion
    • 6. Review/Wrap-Up/Questions
      • A. Responses to 483 Observations
      • B. Managers Can. . .
      • C. FDA reference sources
    • 6. Review/Wrap-Up/Questions A. Responses to FDA-483 Observations
      • 1. At Close Out Discussion
        • a. Assure clear understanding
        • b. Correct any errors
        • c. Provide corrections already in place
      • At Close Out Discussion
        • Don’t over react or over promise
        • Request clarification on issues
        • Don’t argue
      6. Review/Wrap-Up/Questions A. Responses to FDA-483 Observations
      • At the close out discussion
        • Keep a positive attitude
        • Don’t blame FDA
        • Promise a prompt written response
      6. Review/Wrap-Up/Questions A. Responses to FDA-483 Observations
      • In writing always
        • Assure clear understanding
        • Correct any errors
        • Provide corrections already in place
        • Provide additional supporting data
        • Provide decisions subsequently made
        • Provide time frames
        • Provide periodic updates
      6. Review/Wrap-Up/Questions A. Responses to FDA-483 Observations
    • 6. Review/Wrap-Up/Questions B. Managers Can. . .
      • Manage preparation efforts
      • Insure your work areas are orderly
      • Verify your area equipment and instruments are clean and calibrated
      • Instruct employees that all logs and production documents are filled out completely, accurately and legibly; at time of performance
    • 6. Review/Wrap-Up/Questions C. FDA Reference Sources
      • Compliance Programs
      • Investigations Operations Manual
      • Compliance Policy Guides
      • Regulatory Procedures Manual
      • Inspection Guides
      • Laboratory Procedures Manual
      • Code of Federal Regulations (Part 21)
      • Agency Guidance Documents
      • Federal Register
    • I’m so glad the inspection is over. The FDA is gone.
      • Well, think again.
      • 1. Me responsible? No, you and the Company.
      • 2. What is debarment?
      • 3. Penalties/prosecution
      • 4. Warning letter a warning-or a promise
      • 5. Always confident-never complacent
      • 6. Now you, the company, and the FDA (we) have a baseline benchmark for continuous cGMP compliance improvement.