Inspection Readiness Training

Inspection Readiness Training
Victoria Niven Global Quality Operations Training and Program Development

Agenda Introduction What can we do to prepare? Individual interactions
Investigative Techniques During the Inspection Final notes

Learning Objectives At the end of the training you will be able to:
Define general inspection preparation activities Define the Dos and Don'ts of interacting with inspectors Identify different investigative techniques Define actions to be taken during the inspection

1. Introduction

Inspector Responsibilities
In general, inspectors assess compliance to relevant GMP references /cGMP expectations and issue a detailed report. Pfizer Auditors may also provide advice / guidance

Inspector Preparation
A regulatory inspector may review some of the following in advance : Company file held by the regulatory authority Site Master File Manufacturing Licence Registration Dossiers Previous inspection records A Pfizer auditor: May ask you complete a client profile Have a pre-audit teleconference

Regulatory inspector may ask to receive some of the following in advance: Annual financial report Complaints file Questionnaire providing specific information about the company Layout of site and diagrams Manuals Standard Operating Procedures

Some inspectors may prepare a checklist or aide-mémoire A general outline or program will also be drafted. Should be used to ensure the right people are available

Methods of Fact Finding
Trace Forward Follows the production flow from receiving starting materials to dispatch of product from the warehouse. Trace Backward Review the history of a batch through the various processes Random Start from points around the factory that appear to be significant. The inspector chooses which method, but the Trace Forward is the most common method.

Taking Notes The inspector will take notes, writing:
Details and facts (will trust but will verify) Specifics, not generalisations Specific records will include: Names of persons interviewed (and job titles) Document numbers and who receives them These people may be then be interviewed Equipment numbers Item identification Layouts Obvious non-conformities

2. Site Preparation

Preparation - Leadership
Pick an audit team and define their responsibilities Allocate rooms Inspection Room (where the inspector will be based) Back Room (where we prepare and hold relevant documents) Ensure that documentation is prepared See List Ensure that colleagues are trained and understand their responsibilities Ensure each area is clean and compliant (housekeeping) Ensure that there is a sign at the entrance advising that no cameras or video equipment are allowed Review of Previous Deficiencies. One of the first activities that should be undertaken by the SRI Team is to comprehensively review all previously issued GMP deficiencies (e.g. FD-483 observations), including those at other Pfizer facilities. This review must ensure that these deficiencies have been properly addressed by reviewing supporting documentation against commitments made by the plant to the agency. If this review determines that a previous deficiency has been incompletely or improperly addressed, a corrective and preventative action (CAPA) plan must be implemented to remedy the situation as soon as possible. All supporting documentation for each previous commitment should have been assembled in individual binders for presentation during a follow-up inspection. Inspection Readiness Assessment. If time allows, an inspection readiness assessment should be conducted well in advance of any inspection. This is especially important prior to the submission of a regulatory filing since the assessment may result in a decision to delay the filing until critical deficiencies are corrected. The assessment should be conducted by outside personnel, either consultants or CQA representatives, capable of giving a reliable report on the ability of the plant to withstand an inspection. Recent process assessments performed by Corporate Quality Assurance may be used in lieu of the inspection readiness assessment. The results of the assessment should be provided to the SRI Team. If it is deemed that certain issues cannot be resolved before the inspection, a corrective action plan with target completion dates should be developed and approved prior to the inspection. 3. Mock Inspection/Interaction Training. Mock inspection and interaction training will be given just prior to the inspection. It is not necessarily meant to uncover compliance gaps, but is intended as a dress rehearsal for those who will have the most contact with the investigators. Receptionists and security personnel will have such training prior to every inspection. In the mock inspection, plant personnel are provided training on how to interact with an inspector, systems for document delivery are tested, and personnel and strategies for presenting information are prepared. This is an invaluable exercise and should be conducted by someone well versed in the conduct of regulatory inspections. 4. Inspector Background Search. Knowledge of the inspector’s background can be invaluable in preparing for inspections. For example, most inspectors tend to cite firms for the same or similar deficiencies, such as computer validation deficiencies. In the case of FDA inspections, previous 483’s, Establishment Inspection Reports and other documentation can be obtained under the Freedom of Information Act. The information about the inspector’s background, combined with a good understanding of the purpose of the inspection, can be used to predict areas or topics that should be prepared for close examination during inspections. 5. Inspection Notebook/ Site Dossier. An inspection notebook or site dossier should be prepared to assist the inspectors. The dossier should include a company profile, organization charts for all functions, a list of products manufactured for the market of interest (e.g., US for FDA inspections), a full description of the product being inspected (including manufacturing processes), process flow diagrams, a history of recent inspections at the plant (optional), and QA-controlled floor plans. Preferably, these should be bound and should give a professional impression. 6. Documentation. Handout has a list of documentation that is typically requested and must be easily retrievable during an inspection. Copies of these documents should be gathered in the War room or other central location. By having this documentation at the ready, the inspector will feel reassured that the plant has a good command of the information at its disposal and is cooperating fully in the inspection. Failure to respond to documentation requests in a timely manner is the quickest way to set a negative tone in the inspection. For FDA and MCA inspections, critical documentation (e.g. important SOPs) should be available in English to facilitate the inspection. 7. Final Walk-Through. Just prior to the inspection, a final walk-through should be made of the plant. This walk-through can be conducted by the area responsible managers and should focus on general housekeeping issues. It is extremely important to convey a good initial impression when the inspector arrives. When areas present themselves as neat and clean, clearly identified, and well-organized, many questions related to various control issues may not even arise. In addition to housekeeping, the walk through should look for uncontrolled documents, tipex, equipment that is out of place or not cleaned, control of quarantined areas, proper instrument calibration dates, etc.

Preparation - Who Should be Involved
Managers and Leaders should be prepared to answer questions on work that is done in their areas of responsibility Any colleague may be asked to explain what work they are doing

General Documents – amend as appropriate
Copy of registrations under review during the inspection. Product specifications Site master file (in the case of EMEA inspections, this should be provided to the inspection team as far in advance as possible). Index (list) of all SOPs used by the site Translations (where necessary) of critical SOPs, including those describing the handling of OOS results, deviations, media fills, change control, SOP management, training, environmental monitoring, etc. Qualification dossier for any contract laboratories or packagers used. List of lots manufactured for the market of interest during the inspection, including the date of manufacture for the previous 12 months. List of deviations since the previous inspection with translated titles. Have associated deviation investigation files on hand as well. List of OOS results (both initial and confirmed) for the last 12 months. Have associated OOS investigation reports on hand. Most recent Product Quality Reviews / Annual Reviews. Technology Transfer Reports (where appropriate) List of major changes to the site (organization, facility, equipment) Environmental monitoring and water testing quarterly reports and trending data. Product development report (in the case of pre-approval inspections). Complaint files Process flow charts and diagrams List of batches on stability for the market of interest. Be prepared to present stability failures and associated investigation reports. If applicable, list of media fills from the last two years and their results. Have media fill batch records and any associated investigation reports on hand. Approved WFI, HVAC, (and other critical utility) system drawings. List of critical equipment used in manufacturing. Have validation (IQ/OQ/PQ) reports available. List of all computerized systems used in any aspect of production and associated computer system validation reports Cleaning validation reports General Documents – amend as appropriate

Audit Team Roles & Responsibilities Initial Contact Inspection Escorts
Scribes Runner Back Room Administrator Subject Matter Experts Trainers Notes: These are the roles and responsibilities that will be discussed in this section

At no time can an inspector be on their own.
Audit Team For each inspector there should be: 1 escort 1 runner 1 scribe !!! Important !!! At no time can an inspector be on their own. This is employed on an as needed contingency basis. So, for a general plant tour where three inspectors are present, but can be reasonably expected to stay together, we would not detail 9 site personnel to go around with them. 1 escort, maybe two, just in case, probably a primary scribe and a back-up nearby, and maybe 2 runners.

Roles & Responsibilities Initial Contact
Security must Greet the Inspector(s) and sign them in as a visitor (with badge) Notify the Site Quality Authority representative Initial Site Quality Authority contact: Greets the guest and verifies the sign in Escorts inspectors to designated meeting room Conduct introductory meeting with designated participants Trainers Notes: Security should have a contact list for when the FDA or other regulatory agencies arrive.

Roles & Responsibilities Initial Contact
During the Introductory Meeting Extend normal business courtesy Request Inspectors agenda indicating purpose, scope and expected duration of the inspection Develop / agree on tentative schedule for the inspection Present overview information on the site Trainers Notes: Go through the scenario of an inspector entering the facility. What are the logical first steps that should happen? Who will be the person to perform this greeting? Will you be individuals that will attend the introductory meeting?

Roles & Responsibilities Inspection Escorts
Accompany the Inspector at all times ensuring designated attire for the area is provided Set the tone & maintain courteous and professional attitude Ensure that all questions are within the scope of the audit Introduce the Inspector to others Be present during all interviews & discussions Assist in ensuring that colleagues understand the questions Trainers Notes: What does the last point mean here? Assist in ensuring that colleagues understand the questions without leading them – seek clarification Example: How do you operate this piece of equipment, escort says: you use the SOP don’t you??

Remain in contact with management Communicate with the scribe and runner Manage time and logistics Enforce company rules Ensure that identical samples are taken at the same time the samples are collected for the Inspector

Manage the document review and interview phase in the inspection room. One document at a time to the inspector When finished with the document, take it away and then present the next document If this process does not run smoothly you will quickly lose control

Do not keep the Inspector waiting Do not engage in stalling tactics Do not refuse to produce a record because the Inspector does not request it using the your terminology (e.g., “batch” Vs. “production” records) Adversarial – confrontational, challenging, opposing

Roles & Responsibilities Scribe
Crucial part of the audit – cannot rely on memory Take detailed, real time notes Provide a detailed, dated listing of all documents, samples or other items reviewed by, requested by, and/or provided to the Inspector Record who, what, when, where during the audit Summarize topics covered during the day Include a list of potential observations or inspector concerns Note: Keeping notes is important for all audits, however the distribution of the daily notes is different

Roles & Responsibilities Scribe –Taking notes
Avoid long descriptive text Use key words Don’t write anything down unless you understand what you are writing Draw diagrams/pictures Rewrite / finalise notes as soon as possible

Roles & Responsibilities Runner
Accurately document and track every request made by the inspector Ensure requested information and documents are given to the back room administrator, ready for logging and taking to the inspector

Roles & Responsibilities Subject Matter Expert
Have extensive knowledge of policies, procedures, operations, and organizational structure for their area Have the authority to access all information To be able to communicate and explain clearly and rationally

Roles & Responsibilities Back Room
One individual designated as the Administrator, to: Contact necessary personnel Ensure that all colleagues who have been requested by the inspector pass through the room for preparation Maintain a list of those being interviewed Ensure that the colleagues are informed about what he/she can expect during the interview and if possible where the line of questioning is leading Make the colleague feel relaxed and well prepared Debrief colleagues post interview People Management

Roles & Responsibilities Back Room
In addition, the back room administrator must: Track all outstanding inspector requests and their status Review the documentation the colleague has brought with them to ensure it is really what the inspector wants Acquire duplicate copies (or reference controlled systems) of items given to the investigator Ensure all confidential documents provided are marked ‘CONFIDENTIAL’ Catalog all requested documentation Documentation Management

Materials & Equipment Copiers, Fax, Phone Computers Flip charts
Stapler/Staple remover Notepads Clipboard Regulations and references Log Document Request Paperclips Confidential & Uncontrolled Copy Stamp Extra ink

3. Individual Interactions

Individual Preparation
Make sure areas are neat and clean and professional Ensure organization charts are up-to-date Ensure that all documents are properly controlled Locked areas should be locked Reagents, solvents, disinfectants should be properly labeled Equipment status should be clearly identified Recording charts and logbooks should be appropriately reviewed and signed. Many more items could be added to this list depending on your area What are your ideas on this? What are you going to do now in your area? Take a few minutes now (coffee??) to think about this because you are going to do this at the end.

Individual Preparation – Underlying Questions
Do you know what you are doing? Do you know why you are doing it? Do you have evidence to show you have done it correctly? Is everything under control? When something goes wrong, how do you correct the problem and how do you prevent it from happening again? Trainers Notes: In most cases, the inspector is looking for documents or records that answer these questions, including: 1. SOPs, methods, protocols, specifications, and master formulae that describe what is supposed to be done. 2. Validation reports, development reports, and other documents that provide reasons for why something is done a particular way. 3. Records, logs, batch records, and lab results showing that you are properly accomplishing the SOPs, methods, and other written procedures. 4. Deviation reports, OOS logs, quality trending, product quality reviews, recalls, and complaints that give an inspector an idea of the level of consistency and control. Also, the inspector will subjectively evaluate how people respond to questions and how quickly they provide information. 5. Deviation Reporting System (DRS) and CAPA

Interacting with Inspectors
Pfizer’s policy is cameras and recorders are not allowed during a inspection (should have a sign at reception) If an inspector insists on using cameras & recorders, discuss this with site / regional leadership to make the decision.

Body Language Total = 100% What is the % for Total Communication?
Voice = ____% Words = ____% Total = 100% Then go over the actual research numbers calculated: Body: 60 % Voice: 30% Words: 10%

What does your facial expression say about you?
Interacting with Inspectors What does your facial expression say about you?

4. Investigative Techniques

Investigative Techniques
Be Aware of interviewing techniques to: Obtain additional, volunteered information Validate –or- invalidate information already gathered Compare / contrast information Test knowledge or understanding Identify potential issues or concerns Assess honesty, integrity, credibility Trainers Notes: Inspectors utilize a number of techniques during their inspection in order to gather as much information as possible. It is found not only in the types of questions that they ask but also in how they ask them. They will also be aware of your behavior and body language as well as those around you. It is not uncommon for inspectors to ask for the same information from the same person in two different ways or ask separate people. Not only do they obtain the answer to the question but they can ensure there is a consistent message across the business unit, that individuals are not trying to hide any information, or that possibly on individual did not have all of the information available and they can gather further information form another source.

Silence Open Ended Questions Fishing Trips Redundant Confirming Questions Hypothetical Questions Eye Contact and Body Language Trainers Notes: We will go over each of these different types of questioning. If you have ever experienced any of these types of techniques, please share your story with the class so that we can all learn from it. Try to recognize if you have ever had these types of questions asked to you by a regulatory authority.

1. Silence Strategic pause – “whoever speaks first loses” Allow the inspector to make the next statement – keep quiet Trainers Notes: Silence is a common technique. Inspectors can sit for a few minutes looking at you or at a document without saying a word. Five minutes will seem like five hours when you are nervous and it is completely quiet. Typically this is when people start to get talkative to fill in the void. They will start to volunteer information that the inspector has not asked for. This can sometimes bring up information that the inspector was not aware of. Make sure that if there is silence, be silent. Only speak when you are spoken to and do not volunteer information to an inspector.

Investigative Techniques: Example – Silence:
Inspector: “What is the test you are currently performing? Analyst: “An HPLC assay for a new product.” Inspector: Silence and staring ……………………………… Analyst: (feeling awkward)….and, em, this is the first time I’ve done this assay by myself. It’s difficult to perform. See all these sample dilutions I have to make. Takes me all day. But, of course, I won’t be staying late today because I’m in the soccer final. John said he’d take over and…..(escort cuts in and ends the conversation). Trainers Notes: You can practice this with them. Ask the class the question and time how long you are quiet. It will seem much longer than it really is and you can start to feel the tension rise in the room.

Investigative Techniques: Example – Silence:
Inspector: “What is the test you are currently performing? Analyst: “An HPLC assay for a new product.” Inspector: Silence and staring ……………………………… Do not continue on with your answer. It is okay for there to be awkward silence in this instance. Wait for the inspector to ask another question or move on. Trainers Notes: This is how a colleague should handle the situation.

2. Open Ended Questions Inspector’s goal is to get excessive and volunteered information Ask for specificity and answer the specific question, don’t elaborate Trainers Notes: The inspector can ask an open ended question for two reasons: They really don’t know what information they are looking for and they are hoping that you will offer them something good. They want to ensure that you are familiar with the area in question and by giving a general question you may be forced to discuss the area in more specific details in order to answer the question. Either way, inspectors are hoping that information will be offered to them that will help them in their investigation. It may open up a can of worms that the inspectors was not previously aware of.

Investigative Techniques: Example – Open Ended Questions
Inspector: (observing an analyst performing a test method) “What difficulties do you encounter with this method?” Colleague: “Well the machine is quite old, so sometimes this lever sticks. Other times, if the humidity is high in the lab, then the product will stick to the inside of the container, and ………..” Trainers Notes: This is not a direct question for a particular problem. This opens the colleague to tell the inspector all of the problems they have ever had with the equipment, the test, the product. You want to narrow the focus of the question if possible to ensure that you are only giving them the information that they are asking for.

Investigative Techniques: Example – Open Ended Questions
Inspector observing an analyst performing a test method: “What difficulties do you encounter with this method?” Colleague: “I perform sampling according to SOP XXX. If there are any difficulties I refer to SOP YYY. Escort or Supervisor: Try to get them to focus the question by asking them to explain further what type of information they are looking for. Trainers Notes: Asking the inspector to rephrase the question may cause them to become more specific with the information that they are looking for. This puts the ball in their court to take the questions from the general to the specific. You can also repeat the question for them stating the question in a more specific manner to avoid offering too much information and ask if this is what they are asking for. If they say then just offer information about that specific area and what for them to ask another question.

3. Fishing trips Inspectors like to open cans of worms Try to specify Provide the information requested, no more and no less If you do not know the answer, defer to the escort Trainers Notes: Fishing trips start when an inspector doesn’t really ask a question about a process or a material but rather ask to see large amounts of records or files. This is done in the hope that by reviewing all of these files or records the odds are that they will stumble into a problem. It is most common that inspectors will ask to see complaint files, deviations, CAPA files and validation protocols. They will sometimes not ask for a particular business unit or product but rather ask to just see the files. This implies that they want to review them all, which can be a very large amount of records.

Investigative Techniques: Example - Fishing Trips
Inspector: “Can you show me your complaint file?” Colleague: “Sure. Let me show you where we keep it. The document manager there can get you a copy of any one that you would like to see” Trainers Notes: Do not take an investigator to an area where you store files and allow them to pillage through them on their own. Specifics records need to be requested through the proper procedures and then photocopied for the inspector to review. Ask the inspector if they would like to focus on a particular product class or the last six months of complaints. Try to focus them into a smaller amount of records for them to review so that it is more manageable for everyone involved.

Investigative Techniques: Example - Fishing Trips
Inspector: “Can you show me your complaint file?” Colleague: “I would be happy to. Could you tell me what product or production area you would be interested in?”

4. Redundant confirming questions Do not rush, think before you answer Stick to your original answer, do not elaborate Trainers Notes: No the inspector has not lost their mind or come down with temporary amnesia. They will ask you the same question more then once for good reason. Sometimes they may rephrase the question and sometimes they may just wait some time and ask the exact same question again. They want to ensure that you are offering them an accurate and consistent message. If they feel that you were not confident in your answer the first time they asked the question, they may ask it again to see if they get the same answer. This is a way to try to trip someone up if they are lying about something or trying to cover something up.

Investigative Techniques: Example – Redundant Questions
Inspector (looking at a scale): “How would you go about cleaning this piece of equipment?” Colleague: “The scale is cleaned as per SOP xxx.” Inspector: (At an additional scale of the same make in the laboratory) “To clean this piece of equipment you would wipe it down with alcohol correct?” Colleague: “This scale is also covered by SOP xxx.” Trainers Notes: Ensure that you give the same answer as the previous questions. No more and no less information.

5. Hypothetical questions When asked a hypothetical question about a work process, respond by referring the particular procedure. Try and keep the discussion realistic based on actual facts or history. Don’t play the “What If” game as this may introduce “unreal” concerns Trainers Notes: Never directly answer a hypothetical question. You can not ignore the inspector completely but try to give them an answer based in reality. Refer to policies or procedures. You can also refer them to the leadership in the area. But do not play the ‘what if’ game with them because you could open yourself up to scrutiny and questions that aren’t necessary.

Investigative Techniques: Example – Hypothetical Question
Inspector: “What would you do if a machine broke down?” Operator: “Oh that would never happen. We take really good care of our machines here. We have a great preventative maintenance program that I supervise.” Trainers Notes: Never use the words ‘that would never happen here’. Immediately that will push the investigator to prove you wrong. Once he does prove you wrong it will look like you were lying or trying to cover something up. You should also not give a hypothetical response; “well if that did happen then I might xxxxx or I might xxxx.’ Those are not actions based on procedure or policy then they may be wrong and not what should be done in a validated system. Be sure to only offer answers for actions that are referenced in controlled approved documents.

Investigative Techniques: Example – Hypothetical Question
Inspector: “What would you do if a machine broke down?” Colleague: “Procedures for operating this piece of equipment and what to if there are interruptions are defined in SOP xxx” or “As SOP xxx states, I would contact the area supervisor.”

6. Eye contact and Body Language Be honest and relax If you think you made a mistake, work with the escort to assure mistaken information is taken care of in an appropriate manner; offer to contact the appropriate resource to get the correct answer Trainers Notes: When individuals are talking 60% of the message is coming from their body language. How you move and react to someone says a lot about how you feel. Make sure you are aware of your body language when you are speaking with or near an investigator. Do not be nervous or anxious. Do not avoid eye contact or disappear when an investigator enters an area. They will notice and think that something is wrong.

Investigative Techniques: Example – Body Language
Inspector may ask an operator a question while they are working near a production line. Do not pretend like you cannot hear them because the machinery is too loud or avoid eye contact so that they will not speak with you. This looks like avoidance and will be viewed as suspicious behavior. For example, an Inspector enters into the manufacturing area and slowly all operators leave the area and exit into the packaging area to avoid being questioned by the inspector Trainers Notes: If everyone in one area leaves at the same time, the inspector will notice. They have their eyes and ears open to their surroundings. Also, don’t avoid eye contact assuming that the inspector won’t ask you question if they can’t make eye contact with you. Avoiding eye contact may make them feel that you are trying to hide something from them. Be open and honest and relaxed.

5. During the Inspection

Key Points Tour Thing to do / not to do
Implementing Immediate Corrective Actions Daily Debriefing Meetings Concluding the inspection Follow up action Items

Tour Those colleagues who are associated with the route should be notified that it is about to commence The escorts must remain with the inspector at all times If the inspector wishes to look in another area that is not on the ‘planned’ route then those ‘other’ areas can also be toured Detailed notes should be taken Change wording to not being instructive, more passive, this is what will happen

Things TO DO Act in a professional manner
Show an interest in their recommendations and comments Let them talk and listen carefully Provide prompt and courteous responses “Politely” point out published references to support your policy and practices Ask the Inspector to point out observations as they are noted Try to determine the point of the observation or concern Research the situation and formulate your response Present your response at the appropriate time; e.g. end of the day If answering quantitative questions - Inform the inspector that you will provide an answer after reviewing the appropriate records

Things NOT TO DO Be nervous Lie to the Inspector
Interfere with the Escort/Inspection Team Argue or extensively debate with the Inspector Argue with others when the Inspector is present Answer “off-the-record” questions Guess or provide approximate answers Correct other people in front of the Inspector Interrupt someone else’s answer Interrupt the Inspector’s comments and explanations Provide your opinions Answer for someone else Answer questions that do not pertain to your department or operations Use the Inspector as your consultant

Things TO DO – When reviewing Records
Provide general assistance with the format of the records Locate the information or data that addresses the Investigator’s question or request Have an expert or the responsible person available to answer follow-up questions Be sure you have people who are knowledgeable in the area where the investigation is being held to answer questions. For example, you don’t want a general manager to answer a question in the lab; you want the person who is there working daily with the equipment to answer the questions. Be helpful – if you know where the answer to a question is in the SOP, help the Investigator locate that specific section.

Things NOT TO DO – When reviewing Records
Point out errors Correct errors during the review Comment or “apologize” for the quality of the data Comment on plans to improve recordkeeping practices, unless criticized by the Investigator Make constant references to planned SOP revisions, unless criticized by the Investigator Provide a detailed explanation/ translation, unless specifically requested Again, don’t interpret. Don’t feel nervous or compelled to explain more than what is asked or records and data. The Inspector learns more by what you tell them, so tell them only what is pertinent to their question then stop and wait for the next question. Don’t make comments like “It should be…” or “we meant to…” If an observation is made for a bad practice, but you know there is a plan in progress already to fix it, go ahead and say so – you are getting cited anyway, so at least they will know you have already recognized the problem and are working on correcting it.

Implementing Immediate Corrective Actions
A systematic approach should be taken here and interdependencies considered It should be ensured that the corrective actions do not conflict with other methods, procedures or policies All change control procedures should be followed Creating new problems should be avoided Shortcuts should not be taken Global Implications should be considered Trainers Notes: Sometimes it is possible to implement a corrective action to an observation while the inspection team is still at the facility. When this is possible, make sure that it is discussed with management and QA before making any commitment to the investigator.

Implementing Immediate Corrective Actions
Observations noted by the Inspector that are readily correctable shall be corrected as soon as possible (preferably before the close of the inspection). The inspector should be requested to note the corrections in their report Trainers Notes: Examples: SOPs rewritten and implemented while inspection still ongoing Or possible repairs made to structures or fixtures. Ensure that the inspector is aware of the change and it is denoted in the inspection report. Sometimes inspectors will not include the observations as a 483 if it is corrected prior to the inspection conclusion.

Daily Debriefing Meetings
Listen carefully Any concerns should be addressed the next day rather than contesting them at the debriefing Time of return the following morning should be confirmed Any preparations required to move the inspection along should be established 2nd bullet: Any concerns should be addressed the next day rather than contesting them at the debriefing unless it is a quick clarification

Concluding the Inspection
The Exit meeting should include only key participants and S-QRT members Colleagues should attempt to fully understand any observations made by the Inspector If there is disagreement with points raised by the Inspector, these opinions should be politely expressed as well as in subsequent written responses Trainers Notes: S-QRT - Site Quality Review Team It is good to test for understanding at each daily wrap session before waiting till the end. You do not want to get to the end of the inspection and find out that you could have avoided a 483 item by performing a corrective action immediately if you had truly understood what the inspector was unhappy with. If the QO approves the specific action first, then the site can commit to it during the wrap-up session. Do not assume that you always need to agree with the findings of the inspector. Do not become argumentative while discussing the point but do be sure that your opinion is noted in case of discussion in the future. Be sure that you have any necessary data or records to back up your opinion.

Concluding the Inspection
Colleagues should avoid committing to specific actions to the Inspector during exit meeting A designated colleague shall be identified to submit a written response to the inspector/ authority within the agreed timeframes Again not instructive

Follow up actions A written response to the report should be drafted by the Site Quality Authority, reviewed and agreed to by the SQRT. Responses to Regulatory audits are also submitted to the responsible QOAL, responsible Manufacturing Team Leader, and VP Global Quality Operations, for review and approval.

6. Final Points

Remember!! Gain the inspectors trust, through Planning
Organization, and Professional behavior

Desired Inspection Outcome
The inspector leaves the site thinking that we are professional, knowledgeable, competent i.e. we are doing the right thing for our customers and operating in a state of control All documents and data requested were presented to the inspector is good time All documents and data were complete and correct, and adequately addressed their concern There was no antagonism / arguments between the inspector and the site colleagues There was a controlled and efficient atmosphere What would be a successful outcome for you?

Summary Individual actions can have a large effect on the investigator’s perception of our company and on the inspection’s outcome. Do your preparation Know what you are responsible for Be professional and courteous Only answer what is asked Understand all questions clearly before answering Remain calm! Trainers Notes: Each person who meets directly with an agency official or who helps to support an inspection plays a critical role. Little things, said and done, can have an enormous impact on what the inspector thinks of the firm. If the firm can show that it is concerned, that it really wants to do the right thing, and that it has visible management support, the firm will do much better in “surviving” an inspection.

Please complete your training record and your learning evaluation
Questions ? Please complete your training record and your learning evaluation

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