enterey life sciences consulting pda so. cal pai presentation3
DESCRIPTION
Prep and execution for a PAI inspection, we typically organize our preparation activity into four main areas:Plan, Prepare, Execution, and Response & Maintenance.TRANSCRIPT
PAI: Pre‐Approval Inspection Presentation Panel Discussion Script
In discussing prep and execution for a PAI inspection, we typically organize our preparation activity into four main areas:
Plan, Prepare, Execution, and Response & Maintenance.
Phase Questions Talking Points (Answers)
Planning:
Initial Question: Looking back on your efforts to plan for your recent PAI, can you give us some insight into when you really start thinking, “we need to plan for an inspection”, and what did that plan look like?
Published guidance docs (7346); Field guides; experienced team members (Pink Sheet, Gray Sheet, Gold sheet)
High Level Project Plan
Defining Key Elements of a Successful Inspection
Follow Up Questions How did you know what to prepare for?
o Established publications
o Poll the experts o Current Industry
Trends
Once you had a plan, how did you get support internally and convince management that it was worthwhile to dedicate the necessary resources?
Preparation:
Initial Question: So, now you’ve got a good plan and it’s time to get ready. What were the key activities you performed to prepare for the inspection? Short Term: With the inspection just a few short weeks away, I imagine you shifted to “final preparation” mode. Tell the group about how you changed your mindset during that time, and what some of your final prep activities were.
Long Term
Gap Assessment
Gap Remediation
Self‐Inspections (Audits)
Mock Inspection
Identify & Commission the Inspection Readiness Team Short Term (~ Few months prior)
Define the tour route
Stage “obvious” documents
Request information from inspectors (E.g., agenda)
Final practice sessions
Facility “beautification”
Readiness “walkthroughs”
Inspection Logistics
Rehearsing “final team” assignments, and simulation
Getting technology ready, making sure it worked.
Office supplies, Food, etc.
Follow Up Questions 1. How did you monitor progress on closing gaps identified?
2. What were key lessons learned in the Mock Inspection?
3. How did you select individuals to present?
1. Regular meetings; frequency increasing as inspection drew closer.
2. Presenters, communication lines, Tour planning, etc. 3. Planned for specific individuals to be in the inspection
room; most issues handled by inspection team; ability to communicate effectively
4. Sr. Mgmt actively involved; supported inspection
PAI: Pre‐Approval Inspection Presentation Panel Discussion Script
4. How involved was Senior Management in the preparation activities?
5. How did you handle resolving differences of opinion?
preparation activities; ensured participation by key people
Execution:
Initial Question: So, you’ve done all this time preparing – now it is “the day of”. Did it all the planning pay off? How did you facilitate the inspection?
Followed our plan o Opening presentation
Build rapport with inspectors Used presentation to set stage Recommended that we provide a technical
presentation, for their benefit. o Followed planned tour route
Educate, show off facilitate o Adjusted as needed per inspector requests
Execute Logistics Plan o Communication between control room, and
inspection room; records retrieval, presenter prep o Make it look seamless to the inspectors o Know your contingency plans
Follow Up Questions How did you prepare for the unexpected? I.e., did you plan a response if you didn’t have a good answer to a question?
Know what you have (and don’t have), know what your gaps and weaknesses are; and prepare a defense strategy for those. Fall back on procedures, when all else fails.
Response & Maintenance:
Initial Question: Tell us a little bit about the process to respond, and how you managed that work effort?
Know what the response timeline is.
Don’t react, but develop responses that you can commit to and achieve.
Get your questions answered, but don’t be argumentative.
Identify the correct parties to develop the responses.
Get cross‐functional review and approval.
Track commitments to completion.
Follow Up Questions How do you maintain your state of inspection readiness?
Ensure accountability of the functions, with QA Oversight.