abbvie field specialist training -...

AbbVie Field Specialist Training

V 1.3 12/06/2013

Training to include:

• Prescription Drug Marketing Act • Annual , Random and Special Inventory/Storage Review

– Rep Responsibilities Form – Inventory Form – Worksheet – Storage Form

• Closeout – PPD Field Sales Checklist – Return Goods Manifest (RGM) – Equipment Checklist – Rep Certification Form – Speaker Program

• Good Documentation Practices • Math/Counting Review

Field Specialist Responsibility

• Our services are very important to the Pharmaceutical industry. As a Field Specialist (FS) you are expected to take your assignments seriously. Errors, careless mistakes and omissions made may cause problems for the Sales Representative (SR) for whom you are performing the inventory or closeout. The forms completed are official records that are maintained by the client. Please take your time when completing your assignments and follow all directives provided. Check your work while on site with the SR to ensure everything is correct, complete and signed.

Prescription Drug Marketing Act (PDMA)

• The Prescription Drug Marketing Act of 1987 and final implementing

regulations require that drug manufacturers or authorized distributors conduct random audits, physical inventories and reconciliations of Sales Representatives. The purpose of this act is to protect the public health, and to protect the public against drug diversion by establishing procedures, requirements, and minimum standards for the distribution of prescription drugs and prescription drug samples.

PDMA Training continued… • The following are the services we provide for AbbVie:

– Inventories (Annual, Random, and Special)

– Storage Site Inspections

– Field Sales Personnel Close-Outs

Key Definitions

• Drug sample: a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

• Drug coupon: a form that may be redeemed, reducing the cost for a drug that is prescribed.

• FIFO: First in, first out is an inventory term referring to stock rotation, meaning inventory should be used in the order it was received.

• Licensed Practitioner: means any person licensed or authorized by the state to prescribe drugs.

• FDA: Food and Drug Administration.

• Sales Representative: an employee or agent of a drug manufacturer who promotes the sales of prescription drugs to a licensed practitioner.

• Field Sales Personnel: inclusive of sales representative, but also includes management

• Prescription drug: any drug required by federal law to be dispensed only by a prescription.

PDMA Training continued… Inventories

Annual Inventories • Each Sales Representative who distributes samples shall have at least annually, a complete

and accurate physical inventory of all drug samples per the PDMA.

• PDMA regulations require the inventory to include: sample name, strength and number of units in the possession of the sales representative. The recording of lot numbers is an additional requirement of AbbVie.

Random Inventories • As part of the PDMA sample distribution security and audit system companies are required

to conduct random audits on randomly selected sales representatives.

Special Inventories • Special Inventory 1 – Performed at the client’s request as needed. SR has one business day

to comply and complete the inventory.

• Special Inventory 2 - Performed at the client’s request as needed. No advance notice is given to the SR. Scheduling is done through the SR’s manager and is completed with the manager present.

PDMA Training continued… Inventories / Storage Inspections

Storage Site Inspections • Samples must be stored and handled under conditions that maintain their stability,

integrity, and effectiveness and ensure that the drug samples are free from contamination, deterioration and adulteration per the PDMA.

• This can be accomplished by following the labeling requirements of each drug and by client specific standard operating procedures (SOPs).

• You will utilize the AbbVie specific form to determine if the storage location meets the pre-defined guidelines.

• Storage can be either a home or commercial facility as long as it meets the client’s requirements.

• As a Field Specialist you will:

• Check vehicle and detail bag for samples.

• Verify the address of the storage location, noting any discrepancy.

• Review storage guidelines with the Sales Representative and verify the location meets all designated requirements.

• Report on conditions in the storage location.

• Report adverse conditions directly to our office.

• Provide comments as needed.

PDMA Training continued… Field Sales Personnel Close-Outs

• A Closeout is the acquisition of client assets when employees voluntarily or involuntarily leave a company, transfer to a non-sampling position, go on extended leave of absence, or retire.

– Involuntary terminations require sensitivity on the part of the Field Specialist.

– If any hostile situations should occur while on site, please leave the premises immediately and notify our office of the conflict.

• Emergency Onsite contact numbers are provided in your directives for reporting hostile situations.

• The objective is to acquire and account for client assets and return them to the client’s designee.

• Closeouts require quick turnaround.

• Communication to our office while executing a close out is essential.

• Items may include: samples, computer, printer, fax, promotional materials, training information, credit cards, business cards and cell phones.

PDMA Training continued… Field Sales Personnel Close-Outs

• Abbott’s close-out requirements include the following:

– Conduct a final physical inventory of all samples.

– Return drug samples per client specific directives.

– Completion of paperwork: checklist, equipment return form, return goods manifest, and rep certification form

– Pack and ship Sales Representative’s computer, printer and associated items to the client’s designee via FedEx Ground.

– Pack and ship Sales Representative’s literature and associated items to the client’s designee via FedEx Ground.

– Assemble completed paperwork for shipment to the Field Inventory Services office in Richmond VA.

AbbVie Speaker Program Closeout

• Speaker Presentation Length Options: (DEFINITIONS)

– Short Speaker Program - Local Travel is a program requiring the duration of the presentation (including delivery, set up time, questions and answers) to be a minimum of one (1) hour and expected duration of up to two (2) hours. Typically held on site at a health care office/institution (such as a lunch webinar), and which required the speaker to travel a combined total, to and from the speaker program, of less than or equal to four (4) hours or one hundred twenty (120) miles from the speaker's home or office location.

– Long Speaker Program - Local Travel is a program requiring the duration of the presentation (including delivery, set up time, questions and answers) to be a minimum of two (2) hours. Typically held outside of a health care office/institution (such as a restaurant), and which required the speaker to travel a combined total, to and from the speaker program, of less than or equal to four (4) hours or one hundred twenty (120) miles from the speaker's home or office location.

– Short Speaker Program - National Travel is a program requiring the duration of the presentation (including delivery, set up time, questions and answers) to be a minimum of one (1) hour and expected duration of up to two (2) hours. Typically held on site at a health care office/institution (such as a lunch webinar), and which required the speaker to travel a combined total, to and from the speaker program, of greater than four (4) hours or one hundred twenty (120) miles from the speaker's home or office location.

– Long Speaker Program - National Travel is a program requiring the duration of the presentation (including delivery, set up time, questions and answers) to be a minimum of two (2) hours. Typically held outside of a health care office/institution (such as a restaurant), and which required the speaker to travel a combined total, to and from the speaker program, of greater than four (4) hours or one hundred twenty (120) miles from the speaker's home or office location.

AbbVie Speaker Program Closeout Continued….

Section A – Verify information recorded

matched information captured on the Speaker

Program Closeout Form.

Section B – Either the Yes or No box should

filled out completely. All fields must be

completed. If the field does not apply, write in

N/A.

Section C – Ensure a single designation is

selected.

Section D – Ensure a single designation is

selected.

Section E – Ensure the form has been signed

and either the ‘Speaker’ or ‘Attendee’ selection

has been checked.

Attendee List Verification

Verify all fields on the form are complete and

are legible. If the field is not legible, obtain

clarification from the field sales employee and

update the information using Good

Documentation Practices.

AbbVie Speaker Program Closeout Continued….

The header must be filled out completely. What info you don’t have on your assignment sheet,

the SR should be able to help you answer.

All questions must be answered by the SR!

Form is to be signed and dated by both the SR and

the Specialist.

Speaker Presentation Length can be found on the Speaker Presentation

Length Options: (DEFINITIONS) slide

PDMA Training continued… Quality Review • Review completed work prior to mailing to our office. • All forms should be completed per AbbVie specific directives. • Work is reviewed when received by Field Inventory Services. • Your review should include:

– Signatures on all forms (Both yours & the Sales Representative).

– All forms completed. – Math verified. – Good Documentation Practices.

• What we do is confidential in nature. Please refrain from:

– Discussing your personal life or other jobs with the SR. – Become personal with any SR. – Disclose to any SR the names of other clients or services we provide to other clients. – Discuss your position with our company or disclose our payment policy. – Ask for samples or promotional items. – Wait till the last minute to complete your assignments. – Do not volunteer any information or make recommendations to any SR.

Common Situations • SR asks you if they have passed the inventory/audit.

– The response is: I do not make that determination. I suggest you contact your manager or company.

• SR states they do not want you to count samples in the storage area they have not yet acknowledged as being received.

– The response is: All samples in your possession must be counted even if they are not yet acknowledged.

• SR or manager asks you to send an e-mail with the outcome of the inventory/audit.

– The response is: I am unable to provide that type of information since I do not make any determination on the outcome. I suggest you contact your company.

• SR requests you meet at a location other than their storage site to conduct the inventory/audit.

– The response is: The inventory must be conducted where your samples are stored.

• SR refuses to sign off on the inventory/audit.

– The response is: I will make a notation on the form that you did not want to sign. (Make the notation on the form in front of the SR)

Common Situations • SR hands you a count of samples they took before you arrived and the rep wants you to

use that count.

– The response is: I must do the actual physical count of your samples. We will compare your count to mine. If there are any discrepancies we will count together to ensure an accurate inventory.

• SR asks you what other clients you do work for.

– The response is: Our client base is confidential and therefore I am unable to discuss them with you.

• SR requests you set an appointment at a time you can not make.

– The response is: Unfortunately I am booked on that day. I am open (offer 2 other days/times). Please do not provide reasons why you can not meet the SR on a certain day/time.

• SR asks how they (or someone else they know) can get a job as a specialist.

– The response is: I do not know of any openings at this time.

• Remember to keep the process on a professional level with all SR’s.

AbbVie Inventory Training • An inventory is a physical count of all pharmaceutical samples in the

possession of the SR (this includes the storage area, car & detail bag) and an inspection of the location where the samples are stored. Pharmaceutical Companies are required by the Prescription Drug Marketing Act (PDMA) of 1987 to conduct, at least annually, a complete and accurate physical inventory of all drug samples in the SR’s possession.

• Pharmaceutical companies ship samples to their SR who, in turn, distribute samples to physicians. Physicians then give the samples to their patients. While samples are in the possession of the SR, it is their responsibility to account for all samples received from their company and dispensed to physicians and to ensure they are stored in accordance with the labeling guidelines and company Standard Operating Procedures (SOP).

AbbVie Inventory Training • Client projects are uploaded to our secure website for tracking purposes,

called webtool. You will monitor your assignments and provide updates to each assignment on webtool at: webtools.buzzeopdma.com/pdma/login.aspx

– After you are assigned an AbbVie inventory a communication will be sent to you via e-mail requesting you obtain and print the necessary forms & other information off of the File and Email Depot located within webtool.

– The information posted on Webtool contains the forms & directives you will need in order to complete the assignment. Please review the forms & directives. Make sure to update your assignment on the web tool as ‘Received by FIS’ to acknowledge receipt of the assignment.

– The AbbVie inventory paperwork will NOT be sent to you in the mail. All forms must be obtained & printed off of the File and Email Depot.

AbbVie Inventory Training continued…

Rep Responsibilities

Form – Must be

completed by SR prior to

starting the inventory

Storage Review Form –

Used to document Pass/Fail

status of Storage Inspection

Sample Inventory Form –

Used to document the

Inventory and confirmation

that the count was

submitted in MAX properly


• You will obtain all SR contact information and other pertinent information (territory number, customer number, storage address, etc) from webtool. Assignment sheets will not be provided.

• Every assignment comes with client specific directives/forms, use only the current version posted on webtool. The directive will list the forms you need to print and will include the deadline for completing the assignment.

• If you are unable to meet the deadline, run into problems completing the assignment, or are unable to accept the assignment, notify our office immediately. If anything is missing or unclear contact our office. The directive will provide the name & contact information for the client coordinator handling the project. While this is your main contact, anyone in our office can assist you with questions or concerns.


• All samples in the SR’s possession must be included in your count. This includes any samples for which the SR states they have created a return in their system, but are still in possession of at the time of the inventory. Taking an accurate inventory is essential to compliance with the PDMA.

• SR’s that do not have any samples on hand, but do distribute samples to licensed practitioners will need an inventory performed. SR’s that no longer distribute samples to licensed practitioners will not need to complete the inventory process. SR’s on leave of absence will not be inventoried until they return from leave . Notify the AbbVie inventory client coordinator with any reason that would prevent the inventory from being completed within the required timeframe.


• The directive will give you a script to follow when calling the SR, as well as how to best reach the SR. AbbVie prefers you make initial contact with the SR via their internal voicemail system. AbbVie also requires a voicemail be left for the SR’s manager informing them that the SR needs to complete the inventory process. Specific instructions will be found in the client directives. You may utilize any other contact numbers provided for future attempts. Each time you contact the SR, webtool must be updated with ‘sales rep contacted’.

– Be prepared when you talk to the SR. Have more than one date and time to offer the SR. Never give reasons to the SR if you cannot meet them at a day/time they request. If you cannot make a day and time the SR offers, simply state “I have another commitment” and offer an alternate day and time. We ask you to be flexible as the appointment should be convenient to the SR.

– Confirm the location where you will meet. The inventory must take place where the samples are stored, no exceptions. Samples may be stored in the a home or a commercial storage facility. If the SR stores their samples at an address other than the one provided on your website, follow the address discrepancy process outlined in your directives.


– Exchange cell phone numbers to ensure you are able to make contact easily.

– Confirm that the SR’s computer will be present and in working order on the day of the appointment. Email [email protected] if you encounter issues scheduling due to the inability for the SR to have their computer present and in working condition.

– Request that the samples be organized by strength and lot number prior to your appointment.

– Inventories should be scheduled in the morning, before the SR begins sampling to physicians (Start of Business) or in the afternoon, after they have finished sampling for the day (Close of Business). AbbVie has requested the appointments be scheduled 7-9am or 5-7pm unless otherwise requested by the SR.

– Always confirm the scheduled appointment with the SR 24 hours prior to the start time. Ensure, again, that the SR’s computer will be present and in working order for your scheduled appointment.

mailto:[email protected]


• Upon scheduling the appointment, update web tool with ‘appointment date & time’, i.e. 5/22/09, 7AM. Prior to your appointment make sure you have all required forms and directives, SR storage address & cell phone number, black or blue pen, clip board & flashlight. A flashlight may be needed if the storage location is poorly lit.

• Arrive 5 minutes early to the appointment.

• Call the SR if you are running late for the appointment

• When you arrive on site introduce yourself and present your ID Badge.

• Hand the SR the Rep Responsibility form. Have the SR read, sign & date this form prior to beginning the inventory count. Collect this form & return it to our office with in the packet including the completed inventory and storage inspection forms.

• Ask the SR to take you to the area where the samples are stored. Before beginning the count, confirm with the SR that all samples are available for you to count. *Always check the SR’s car & detail bag yourself to ensure all samples are counted.


• AbbVie requires the count to be in units by lot number. Count the number of full cases of samples & multiply by the number of units in the case. Units per case can be found on the exterior of the box or on the product list found on webtool. Next count ‘loose’ units. Add total units in the case and total loose units together to arrive at the total number of units for each product by lot number.

• AbbVie requires you to witness the SR enter the count into their computer. Specific instructions are provided in the directives.

• Before signing the inventory form you both must agree that the count is correct and all samples have been counted and entered into their computer correctly.

– If the SR does not agree to the count; you will recount together. Never sign off until you are both in agreement on the count. Remind the SR of this prior to signing the form.

– If you encounter computer entry problems, have the SR notify the Help Desk while you are on site. If the Help Desk can not resolve the problem while you are on site, cancel the appointment and notify [email protected]. Be sure to supply a detailed reason for the cancellation. The appointment will need to be rescheduled once the issue is resolved.



• The PDMA requires drug samples be stored and handled under conditions that will maintain their stability, integrity and effectiveness and ensure that all the drug samples are free of contamination, deterioration and adulteration. Storing samples in accordance with labeling guidelines will ensure compliance with this requirement.

• An inspection of the storage location will be completed by you and the SR. Read each question on the storage review form to the SR & record their responses. Comments should be provided as needed. Make sure you are clear when making comments. Both you and the SR will sign & date the storage inspection form.

– Sample storage location must be locked and only accessible to the SR. The key must only be accessible to the SR. If samples are stored in the home the area must have a locking device. No one else in the home should have access to the area.

– If stored in a commercial facility the unit must be locked & not accessible to anyone other than the SR. The key(s) or number combination/passcode to the locking device must be available only to the SR.


– Samples must be stored within package guidelines.

• The sample storage location must be temperature controlled by an air-conditioning and/or heating unit.

• The sample storage location must be clean, dry, free of debris, spillage & exposure to pests.

• Samples DO NOT need to be elevated off the floor.

• Before leaving the SR, make sure all forms are signed & dated as required by both of you. Thank the SR for their time.

• If the SR finds additional samples after you have left the inventory, they are to contact the Help Desk for guidance. The contact information is in your directives.


• Prior to mailing completed paperwork to our office:

– Review the forms one last time for clarity, good documentation practices, dates and signatures. If you discover you missed an item needing the SR’s signature, notify our office. Place a call to the SR asking them to meet you to sign the forms. Do not mail paperwork to our office until it is completed properly.

– Always make copies of completed paperwork for your own files. Files must be kept for 6 months.

– Be sure to return completed paperwork to our office within 48 hours of completion of the appointment either by fax, scan/email, or USPS.

• Make sure the address is correct and affix proper postage when mailing via USPS.

– Update webtool with the comment ‘Completed and mailed to Cegedim’ and list the date the assignment was completed in the Date Completed box.


Inventory Training Recap 1. Pharmaceutical Companies are required by the Prescription Drug Marketing Act (PDMA)

of 1987 to conduct, at least annually, a complete and accurate physical inventory of all drug samples in the SR’s possession.

2. An inventory is a physical count of all pharmaceutical samples in the possession of the SR (this includes the storage area, car and detail bag) and an inspection of the location where the samples are stored. Samples for which a return has been created must be included in the count. Taking an accurate inventory is essential.

3. AbbVie Inventories should be scheduled in the morning, before the SR begins distributing samples to licensed practitioners (Start of Business) or in the afternoon, after they have finished distributing samples for the day (Close of Business). AbbVie has requested the appointments be scheduled 7-9am or 5-7pm. If the SR requests an appointment outside of this parameter, please accommodate their request and remind them of the Start of Business or Close of Business restriction.

4. Before signing the inventory form, both you and the SR must agree that the count is correct and all samples have been counted and entered properly into the SR’s computer. If the SR does not agree to the count, you will recount together. Never sign the form until you are both in agreement.

Inventory Training Recap 5. If any changes/corrections need to be made, follow the proper error correction method

noted in the Good Documentation Practices (GDP) training.

6. Any problems concerning the computer entry portion of the inventory are to be directed to the Help Desk while you are on site. If the problem cannot be resolved while you are on site, cancel the appointment and notify the client coordinator listed in your directives. A second inventory may need to be completed once the issue has been resolved.

7. The PDMA requires SRs store and handle all drug samples under conditions that will maintain their stability, integrity and effectiveness and ensure that all the drug samples are free of contamination, deterioration and adulteration. Storing samples in accordance with labeling guidelines will ensure compliance with this requirement. A storage inspection of the location will be completed by you and the SR. Do not adjust the outcome of the SR’s storage inspection.

8. If the SR finds additional samples after you have left the inventory they are to contact the Help Desk for guidance. The contact information is in your directives.

Inventories Rep Responsibility Form

Inventories Sample Inventory Form

All lines not used require a

straight line from corner to

corner, your initials, N/A,

and date

Complete the Header (Info is on

your Assigned but not Verified

website page)

SR must check the

appropriate boxes prior to

signing and dating the form

You must check the appropriate

boxes prior to signing and dating

the form

Computer Entry: The

Only exception is not

being able to enter a

zero inventory due to

system limitations

Random Inventory 1. Pharmaceutical Companies are required by the Prescription Drug Marketing Act (PDMA) of

1987 to conduct, at least annually, a complete and accurate physical inventory of all drug samples in the SR’s possession.

2. An inventory is a physical count of all pharmaceutical samples in the possession of the SR (this includes the storage area, car and detail bag) and an inspection of the location where the samples are stored. Samples for which a return has been created must be included in the count. Taking an accurate inventory is essential.

3. AbbVie Random Inventories should be scheduled with 5 business days of receiving the assignment and may be in the morning, before the SR begins distributing samples to licensed practitioners (Start of Business) or in the afternoon, after they have finished distributing samples for the day (Close of Business). AbbVie has requested the appointments be scheduled 7-9am or 5-7pm. If the SR requests an appointment outside of this parameter, please accommodate their request and remind them of the Start of Business or Close of Business restriction.

4. Before signing the inventory form, both you and the SR must agree that the count is correct and all samples have been counted and entered properly into the SR’s computer. If the SR does not agree to the count, you will recount together. Never sign the form until you are both in agreement.

Random Inventory 5. If any changes/corrections need to be made, follow the proper error correction method

noted in the Good Documentation Practices (GDP) training.

6. Any problems concerning the computer entry portion of the inventory are to be directed to the Help Desk while you are on site. If the problem cannot be resolved while you are on site, cancel the appointment and notify the client coordinator listed in your directives. A second inventory may need to be completed once the issue has been resolved.

7. The PDMA requires SRs store and handle all drug samples under conditions that will maintain their stability, integrity and effectiveness and ensure that all the drug samples are free of contamination, deterioration and adulteration. Storing samples in accordance with labeling guidelines will ensure compliance with this requirement. A storage inspection of the location will be completed by you and the SR. Do not adjust the outcome of the SR’s storage inspection.

8. If the SR finds additional samples after you have left the inventory they are to contact the Help Desk for guidance. The contact information is in your directives.

Random and Special Inventories Rep Responsibility Form

Inventories:

Random and Special

• Random and Special

Inventories do not require computer entry

• All forms will be emailed to you along with specific instructions for faster turnaround and require more flexibility when scheduling

• Due to the sensitive nature, all forms must be returned within 24 hours

Inventories / Closeouts Worksheet

Locate the Correct Product on your

worksheet by comparing the

Description, Product Code (PC), and

Case Count.

Common Problems:

Samples that are the same

brand will have multiple PC’s

and can have a different

number of units per case.

Double check the worksheet,

product list, and actual

samples in order to ensure

accuracy

Count must be

documented Per Lot

Number

Inventories Sample Storage Inspection

If the SR fails any of

the first three criteria,

the fourth criteria

automatically is marked

as a Fail.

If the SR stores

their samples

at any location

other than the

one provided

on your

assignment

sheet,

document the

address

discrepancy

Home

Storage =

Onsite

Anywhere that is not

their home, even if it

is not a commercial

facility is considered

Off-site. Storage

Facility Name and

Storage Unit

Number are

Required

Both the you and the SR

must sign and date the form

AbbVie Closeout Training • Pharmaceutical Companies provide drug samples to their SR’s for distribution to

physicians. Promotional materials, training documents, hardware and vehicles are also provided. When Field Sales Personnel (FSP) leave the company, these assets must be returned to the client. This is where you come in.

• A closeout is the acquisition of assets from FSP no longer in a field based position.

– This may mean they are no longer employed, have been promoted or are taking a leave of absence. Your role is to acquire all client property in a professional and organized manner, document the task and correctly ship the assets. The client specific directive will guide you through the process. All close outs are different; it is important to always read the directives. If you have questions call our office.

• Closeouts require a quick turnaround. You will receive a call or an e-mail from our office inquiring about your availability to complete the assignment within a specific time frame. Due to the time constraints, it is of the utmost importance that you respond to the inquiry in a timely manner. Once you have committed to the assignment, our office will mail the paperwork to you via Fed Ex. If a FSP is not available on such a short turnaround, set the appointment for the closest available date and notify our office.

• A closeout requires a final inventory of samples (if applicable) and acquisition of all assets. Each project is different. The specifics are set by the client and vary.

AbbVie Closeout Training continued…

• Open your package of materials immediately upon receipt. Each assignment comes with client specific directives. Review the directives and forms. If anything is missing from your packet contact our office.

• When you contact the FSP, focus on the target date the client has requested and have several scheduling options available. We ask you to be flexible, remember this is a professional encounter and the appointment should be convenient to the FSP. Be aware of any tasks the FSP may need to perform before the appointment. This information will be in the client specific directive.

• During the initial conversation you should ask the FSP to give you an estimate of the number of boxes of samples, promo & literature they have on hand. It is always good to know ahead of time what to expect when you get on site. If needed you may need to rent a truck to accommodate everything being picked up. If you feel a truck rental is needed, you must notify our office so we may notify the client of the added expense.

• Bring boxes, scissors, packaging tape, and a black marker to the appointment.

• AbbVie requests we utilize FedEx Ground for the shipping carrier. Pre-printed shipping labels will be provided. Contact [email protected] if you require additional labels to complete returns.



• Samples may or may not be on site during the close out. If samples are present, you will need to perform an inventory of all samples. AbbVie requires the count by lot numbers. The client specific directives and Return Goods Manifest (inventory form) will detail what information to capture for the inventory. It is essential you capture all of the information during the close out. The inventory count must be accurate. Double check yourself.

• When both you and the FSP are satisfied that all samples have been counted and correctly recorded on the Return Goods Manifest form (RGM), you will both sign and date the form. Signatures indicate agreement that the count is correct and complete. If you do not agree, re-count the samples together. Occasionally a FSP refuses to sign the form, simply document the form “Representative refused to sign” and sign and date the comment.


• If samples are on site, you will need to package them for shipment. Place full sealed cases of samples into a larger box. This will cut down on the number of boxes being shipped. If you encounter loose units, try to pack same product and strength in one box. If possible avoid co-mingling different products in the same box. On the exterior of the boxes write box 1 of 3, box 2 of 3, etc. It is a good idea to write an ‘S’ on the box so you know they contain samples. A copy of the RGM (inventory form) must be placed in one of the boxes of samples. This is essential for verification upon arrival to their destination. The samples will be counted & verified against your count. If there are any discrepancies, we may contact you for additional information. Place the correct shipping label on the boxes and record the tracking number on your paperwork.


• Close out packets contain a closeout checklist and an equipment checklist. The checklist will list the assets you are to acquire from the FSP; including: laptops, credit cards, promotional material. The checklist may give you specific details as to the make and model of the hardware (laptop, printer, etc) and accessories. The checklist will direct you how and where to ship the items. Secure all items on the checklist. Any item not turned over by the FSP should be documented. A FSP may not have every item listed on the checklist, note any discrepancy. Pack the hardware for shipment; ask the FSP for the original packaging. If they do not have it you will need to purchase boxes for shipment. The hardware should be packed securely with bubble wrap so it does not move around the box. If you purchase boxes make sure the items fit securely. Most shipping vendors will have packing supplies, including laptop boxes. Place a shipping label on the boxes and record the tracking number on the checklist. Make sure you ship items to the correct locations. Most errors that occur are shipping errors.


• Remember the client specific directives should be followed at all times. The directives detail the exact process for the client.

• Check the client specific directives on what to do with promo items, literature or training materials.

• Before leaving the close out check to make sure all forms are completed correctly and signed by both you and the FSP.

• Take all items to the shipping vendor for mailing. Do not leave the boxes until the vendor has entered them into their system and given you a receipt. It is your responsibility to remain with the items. Never leave them unattended. Make sure you have all the tracking numbers.

• Place all completed forms and unused shipping labels in an envelope and mail to our office. If you have retrieved credit cards, keys etc those should also be mailed to our office with the paperwork unless the directives state otherwise.

Closeouts PPD Field Sales Closeout Checklist

Red, White, or Blue references the color

of the shaded FROM section on the

prepaid label. The City, State, and Zip

Code for the correct label is also

supplied in order to facilitate the

shipping process.

Peel off the

Shipper Receipt

Number stickers

and stick them to

the checklist in the

appropriate

section

Shipper Receipt # =

Tracking Number

Shaded

From

Section

Destination

Check off Items

retrieved or

steps completed

in the

Completed/Retri

eved Column. If

the item was not

collected or the

step was not

performed you

must check the

box in the N/A

section, initial,

and date.

Closeouts Return Goods Manifest

Fill in the header

using the info from

your assignment

sheet

Enter the Product

Code (PC), Product

Description, Lot

Number, and Qty

Collected

All lines not used require a

straight line from corner to

corner, your initials, N/A, and

date

List the Tracking

Numbers for all

boxes shipped

List the Box Number

that the samples

were returned in. Ex:

1 of 4, 2 of 4, etc

FSP must check one

applicable statement Both you and the

FSP must sign

and date the form

Closeouts PPD Field Sales Equipment Closeout Checklist

FSP’s Name and Territory

Number should be filled in

for you

Enter the Date the

equipment will be

shipped to Abbott’s

Designee.

List your name

Qty Assigned is filled

in for you. Do not

alter this column.

Peel right sticker (Receipt,

Shipper Number) and stick

on the appropriate

section of the equipment

checklist

Items Collected or

assigned but not

collected should be

noted in the Qty

Retrieved Column.

Anything assigned but

not collected requires

a comment explaining

why the item was not

returned.

All Not Applicable

sections require the N/A

box to be checked and

the box to the right to be

initialed and dated.

Proper Error Correction

is Essential

Closeouts Representative Certification Form

Complete the Header using the

information supplied on your

assignment sheet.

Common Problems:

The FSP’s Employee ID

(also used as their vmx

number) is NOT their

customer number.

Utilize the number on

your assignment sheet.

Both the FSP and you must

sign and date the form

The FSP must check off

the appropriate boxes on

the form prior to signing

and dating the form

AbbVie Closeout Continued…

How to fill out the Representative

Responsibility Form Correctly:

1 – Sales Reps Full Name.

2 – SR’s Customer # & Territory #.

3 – Your Name.

5 – SR either has or hasn’t submitted

samples calls.

6 – SR is to sync iRep in the iPad in front

of you. You either check #7 Successful if

it is completed or #8 if they were unable

to or it failed. If it failed please write and

explanation of why in #9.

10 – SR printed disbursement copies for

their records. Check #11 if they have and

#12 if they have not.

13 – SR understands they are to kept a

copy of all records for 40 months.

14 – SR’s signature and date.

15 – Your signature and date.

AbbVie Good Documentation Practices (GDP) Training

• Documentation needs to comply with Abbotts requirements.

• AbbVie is subject to auditing by the FDA.

• AbbVie is expected to have documented operating procedures and must fully comply with those procedures. Any service providers used by AbbVie to support regulated activities must comply with the established government regulations as well as AbbVie policies.

• The objective of this training is to provide an introduction to required documentation practices as they relate to the services we provide AbbVie. Paperwork may be returned to you for correction if these procedures are not followed.

AbbVie Good Documentation Practices (GDP) Training

• General guidelines are as follows when completing paperwork:

– Documentation (writing, form entries) must always be legible

• Someone else must be able to read what you wrote

– Printing information is preferred.

– Your signature on a document must contain your first and last name and the current date (Example: John Doe 2/6/12)

– Signatures are incomplete without the correct date including day, month, and year (for example 01/02/12)

– Indelible, non-erasable ink must be used (black or blue ink only)

– The ink must allow for clear copying

– Write-overs, scribbles and multiple lines-through or obscuring the original entry is unacceptable

– The use of correction tape or white-out is not allowed

AbbVie GDP Training Continued…

• Signatures are documentation and/or verification of:

– Documentation correctness (your entries are correct and complete.)

– The task is complete

– Acknowledgment of actions performed

• Pre- and post-dating entries is not allowed

• Subsequent changes or data entries to a document (after the date it was completed) require an additional signature & a date

• Example: Document received by our office that must be returned to you for correction must be signed and dated by you after the correction is made. The date the correction is made must be used.

• Most importantly, signatures are legally binding

• All fields on a document or form must be completed unless the client specific directives state otherwise. If a field does not apply write in N/A, your initials, and date. Leaving a field blank can be interpreted as an error.

AbbVie GDP Training Continued…

• Error Correction Method:

– Corrections or changes to any document must not obscure the original entry.

– The originator that made the data entry must make the data entry error correction or change. If the sales rep makes an error they must make the correction. If you make the error, you must make the correction. Depending on the circumstance our office may make an error correction or change on your behalf. In some cases the paperwork will be returned to you for correction; make sure you follow the proper error correction method.

• Draw a single line through the error

• Sign and date (first initial, last name, and date)

• Write the correction adjacent to or as close as possible to the error line. Make sure the correction is clear.

• Include a statement indicating the reason for the correction.

Unacceptable corrections: Acceptable correction:

Judy Smith 1/6/09 jsmith 2/6/09 Judy Smith 1/6/09 2/6/09

Judy Smith 1/6/09 jsmith 2/6/09 Incorrect date J Smith 2/6/09

Judy Smith 1/6/09 2/6/09 Incorrect date

Correction

must be single

straight line No Reason

No Signature Single line through incorrect date. Legible

signature, and date of person correcting mistake

Math/Counting Review • AbbVie has products that are the same brand with more than one product code. Each

product code can have a different units per case. It is essential that you check the cases &/or Loose Units to ensure accuracy.

Product Code PRODUCT DESCRIPTION Units Per Case

402 NIASPAN TABS 500 mg. 20

403 NIASPAN TABS 500 mg. 60

This label was taken from a

case of Synthroid 100mcg.

Please note the location of

the Product Description,

Strength, Product Code,

Lot Number, and Units Per

Case

Utilize the Product List and

Worksheet Supplied to aid in

accurate counting

The training is now complete. Please click on the below hyperlink

to take you to the test.

https://secure.testcraft.com/buz254/assess.aspx?aid=ABBVIEFISTRAINING2014&apass=ABBOTT



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