Sample Compliance Sop Review 1 Jeopardy Template

General SC SOPs 1	General SC SOPs 2	General SC SOPs 3	General SC SOPs 4	General SC SOPs 5
100 Sample Loss: Inventory loss, casual loss, natural disasters. Loss in Transit: Loss by carrier while being transported. What is the difference between Sample Loss and Loss in Transit?	100 Anyone who handles samples or manages or facilitates sampling programs and anyone identified by Sample Compliance as needing training. Who needs to take the PDMA training and assessment?	100 Vermont What state specific procedure was removed from the Government and State/Jurisdictional Requirements SOP due to the increase of Jurisdiction required regulations and reporting and the need to stay high level on SOPs?	100 False, disciplinary/corrective action for CSOs is carried out by CSO management. Janssen provides content, policies and training and may request removal of a CSO. True or False? CSOs are subject to disciplinary/corrective action administered by Janssen.	100 Once each calendar year. How often does Sample Compliance audit each storage location?
200 Sample Compliance. Who is ultimately responsible for loss reporting?	200 Thefts, losses, violations, investigations of violations, FDA reportables. Name three events that fulfillment vendors must notify the Company about in writing.	200 Capturing the supervising physician name for mid-level practitioners in Michigan. What state-specific procedure was removed from the Government and State/Jurisdictional Requirements SOP because it is no longer a requirement?	200 Group 1 - major violations of state or federal laws, causing risk to the company, possibly resulting in termination. Sample Compliance - Less severe violations of PDMA or Sample Compliance policies, resulting in Compliance Warning. What is the difference between Group 1 Violations and Sample Compliance Violations?	200 Two. Exceeding what % of significant loss reportable per reconciliation in each quarter will require reporting a quality issue and CAPA in TrackWise.
300 False, each state decides the sample eligibility of their health care professionals and reps are responsible to know the regulations in the state in which they sample. True or False? Mid-level practitioner sample eligibility is determined at the national level.	300 Passing score on PDMA assessment, Sample Storage Certification, Sample Storage address in myAlign. Name three things a rep must have prior to receiving samples.	300 A specialty listed specifically on the Sample Distribution Plan as acceptable to sample. What is an Approved Specialty?	300 False, this is no longer maintained by Sample Compliance. True or False? Field associates must maintain a current storage address with Sample Compliance.	300 Two business days. How long does Sample Compliance have to produce inventory records or reconciliation reports when requested by the FDA.
400 An extension must be filed within 30 days of the initial notification. If an investigation remains open longer than 30 days, what must be filed and when?	400 CSO - Contracted Sales Organization. Quintiles employees working for Janssen is an example of what?	400 Brand, in the Sample Distribution Plan. Who is responsible for providing approved and do not target specialties?	400 The samples must be returned for destruction. If it is determined that failure to store samples properly may have affected their integrity, what must happen?	400 Percentage and unit. For a variance to be reportable, it needs to be over both the ________ and the ________ threshold.
500 False, only if reporting is required in that state, reporting is not required in every state. True/False Every FDA reportable must also be reported to the State in which the incident occurred.	500 Jurisdiction. What do we call "the territory over which authority is exercised"?	500 HCC When a sample distribution is made to a practitioner whose specialty is on the "Do Not Target" list, who must be notified?	500 False. Storage locations are approved by Field Management. True or False? All storage locations must be approved by Sample Compliance.	500 Dollar value, Size of manufacturer, reportability to FDA, potential for diversion, security and audit systems, dollar value of inventory on hand, program complexity, product type, indication, safety issues associated with product, size and type of sample configuration, potential street value, size of sales force. Name any four of the factors that may be used in determining a product SLT.

Sample Compliance SOP Review

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