The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do...
Transcript of The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do...
![Page 1: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/1.jpg)
The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on
Site to Conduct an Inspection
A Panel Discussion: Elaine Messa Vicky Stoakes
Joe Famiglietti David Elder
![Page 2: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/2.jpg)
FDA Expectations
• FDA conducts inspections to assess compliance with applicable laws and regulations
• FDA expects:
– Investigators to conduct inspections in a reasonable manner
– Industry to welcome the investigator professionally and do all they can to facilitate an efficient inspection
![Page 3: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/3.jpg)
FDA Expectations (cont.)
• FDA expects: – For minimal delays to occur at the outset of
unannounced inspections; no delays when the inspection was preannounced
– For investigators to conduct efficient inspections with as little disruption to operations as possible
– For information to be provided as swiftly as possible without delay; if you don’t know the answer, explain you don’t and get the person who does know as soon as you can
![Page 4: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/4.jpg)
FDA Expectations (cont.)
• FDA expects:
– For copies of records to be provided in a timely manner
– That inspected parties will be nervous (it’s ok, the investigator is too!)
– To be provided with access to all locations and records related to the manufacturing process; which means every step of the way (no “secret” rooms)
![Page 5: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/5.jpg)
FDA Expectations (cont.)
• FDA expects: – Courtesy and respect shown by all parties
– Investigators to openly communicate the scope of the inspection and findings at least daily
– For contentious issues to arise and for there to be open dialogue; communicate to avoid misunderstanding
– For industry to have procedures for inspections/audits
– For there to be a “war room”
![Page 6: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/6.jpg)
Question #1 for Panel Discussion
Are there common mistakes firms make within the initial hours of the
inspection?
![Page 7: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/7.jpg)
Question #2 for Panel Discussion
Can you offer a gift, coffee or lunch to the FDA Investigator? Is it different
for US vs. OUS inspections?
![Page 8: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/8.jpg)
Question #3 for Panel Discussion
What should you do if you do not know the answer to a question asked
by the FDA investigator?
Part B: What should you do if you realize an earlier answer was
incorrect?
![Page 9: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/9.jpg)
Question #4 for Panel Discussion
The FDA Investigator is asking questions to line operators on the
manufacturing floor, what should we do?
![Page 10: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/10.jpg)
Question #5 for Panel Discussion
Is it acceptable for FDA Investigators to ask for access to computer systems or for database downloads onto CD or
flash drive?
![Page 11: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/11.jpg)
Question #6 for Panel Discussion
At the opening meeting we informed the FDA Investigator that we have a policy
that does not allow photography but she saw a puddle under my WFI holding tank and just took out her camera, how can I
stop her from snapping a picture?
![Page 12: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/12.jpg)
Question #7 for Panel Discussion
What is the biggest mistake you have seen companies make in the “Back
Room” process?
![Page 13: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/13.jpg)
Question #8 for Panel Discussion
During the inspection, is it appropriate for attorneys or
consultants to speak of the firm’s behalf?
![Page 14: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/14.jpg)
Question #9 for Panel Discussion
What should firms do if they believe an FDA Investigator is acting
improperly (e.g. non-communicative, will not hold a “daily debrief,”
inconsiderate/unprofessional)?
![Page 15: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/15.jpg)
Question #10 for Panel Discussion
The inspection is nearing completion and our closeout discussion is
beginning – we just want it to end and we want the FDA Investigator out
of the site as quickly as possible, right?
![Page 16: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/16.jpg)
Question #11 for Panel Discussion
What should we do if we disagree with an FDA-483 observation or
believe that the FDA Investigator is wrong in his facts or conclusion?
![Page 17: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/17.jpg)
Inspection Efficiency
Do… • Have a procedure for hosting
inspections and follow your procedure from beginning to end
• Prepare and maintain a site overview slide deck that can be accessed immediately and cover key people, operations, products, and physical layout of the site
• Make the back room run like a Swiss watch
• Promptly respond to requests the first time they are asked
Don’t…
• Think you can “wing it” without a procedure or have a procedure but then deviate from it without cause or from inexperience
• Be surprised by, and unprepared for, a health authority inspection and then throw any available resources towards its management
• Delay in responding to requests for records or information.
• Make the agency request information twice before getting it
![Page 18: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/18.jpg)
Inspection Thoroughness and Correctness
Do…
• Be honest, always, and without exception
• Use subject matter experts properly
• Assign scribes who can document questions, requests for documents, and persons interviewed and who also understand the bigger picture of the inspection process and company operations
Don’t…
• Be untruthful, deceptive, or withhold relevant information
Put SMEs before the agency who have insufficient experience or ineffective communication skills
Use scribes simply as stenographers (effective scribes can be critical elements of the process)
![Page 19: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/19.jpg)
Inspection Professionalism
Do…
• Create a good first impression
• Identify the correct principal liaison
• Identify the correct support liaisons, who could take on the role of principal in his/her absence of when the inspection takes parallel tracks
• Set up the inspection team in a room of suitable size, lighting, and temperature control
Don’t…
• Have an uninformed receptionist who treats the Investigator as a solicitor
• Select principal liaisons, who lack the knowledge, savvy, or interpersonal skills to be effective
• Forget to select and train more than one principal liaison
• Seek to make the physical environment or the operating atmosphere unpleasant or uncomfortable
![Page 20: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/20.jpg)
Inspection Communication
Do…
• Assure prompt and effective internal communication throughout the process
• Assign scribes who can effectively translate requests and discussion points for collective awareness (not merely record every word spoken)
• ask questions of the investigators and seek clarification of observations or concerns
Don’t…
• Create any gaps in internal communication
• Fail to observe any potential areas of misunderstanding that become apparent through the questions, document requests, and discussions
• Leaving misunderstandings unresolved when the inspection concludes
![Page 21: The 10 Best and 10 Worst Things to Do When FDA …...The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection A Panel Discussion: Elaine Messa](https://reader030.fdocuments.in/reader030/viewer/2022040815/5e5c6d5b584a404e8649d254/html5/thumbnails/21.jpg)
Overall Advice
• Treat the inspection process as an important business activity and manage it accordingly
• For easily correctable items, take action while the inspection is ongoing and demonstrate corrective actions when completed
• Practice – conduct mock inspections of the overall process, including: reception, introductions, site overview, roles of top official, liaison, SME, and scribe, back room functionality, and communication system.