Diego Torillo
TRUE or FALSE. Regulatory Inspections should not be cancelled in EDA if the inspection was not performed.
False
TRUE or FALSE. XEVMPD dictionary check is required prior submission of PBRERs.
True
TRUE or FALSE. CAPA development and/or implementation may need to be expedited to mitigate potential impact depending on the nature and severity of the issue.
True
TRUE or FALSE. The PL creates an inspection notification document using CS_TP_QA02024 Notification of a Regulatory Inspection, and provides it to the QAL
False
Who played the role of Camia Delos Santos-Cruz / Jasmine in Wildflower?
Sunshine Cruz
At what calendar day does the final response document needs to be sent to customer
a. 70 days
b. 75 days
c. 80 days
d. 85 days
D. 85 days
Who played the role of Red Dragon?
Zsa Zsa Padilla
How many days must the customer return all the Call for information data?
a. 1 week
b. 3 weeks
c. 2 weeks
d. 4 weeks
C. 2 weeks
Which character from Wildflower said the following line: "Just like Gold, I am indestructible!"
Lily Cruz / Ivy Aguas
It is as QA tracking database
a. Apex Tracker
b. Event Driven Analysis
c. eTMF
B. Event Driven Analysis
It is the one consulted by the LS RR team for further details of the distribution?
a. AR Specialist
b. AR Coordinator
c. AR QC Reviewer
d. SMP
D. SMP
Defined as the Global Quality Assurance database used to document and manage quality events such as audits, regulatory inspections, findings, quality issues, investigations, corrective/preventive actions and effectiveness checks.
Electronic Quality Management System (eQMS)
Wildflower was aired on ABS-CBN's Primetime Bida evening block at what time?
5:45 PM PST, before TV Patrol
Type of delivery file that is prepared by the GRA publishing team?
XML
Arrange the following step for the submission of HA/PRAC Response (>12 Month Interval PBRER)
I. Add note to SARA APEX Tracker to review responses at next PBRER draft
II. Inform parties regarding delivery of file
III. File all documents with final PBRER in ELVIS
IV. Receive confirmation of delivery
II, IV, III, I
Who legally adopts Lily and raises her?
Priscilla Meirelles / Prianka Patil-Aguas
PSUR line listings include the following, EXCEPT?
a. Medically confirmed serious unlisted, serious listed cases and non-serious unlisted ADRs
b. Medically confirmed non-serious listed cases, if requested by RA’s
c. Medically unconfirmed reactions, if requested by RA
d. None of the above
C. Medically unconfirmed reactions, if requested by RA
Which character said "Na-stress ka ba, Emilia?"
Camia Cruz / Sunshine Cruz
During Issue Assessment and Triage, Lead Quality Assurance Representative is responsible for:
I. Reviews the information submitted and determines the severity.
II. Notifies the QA Vendor Qualification Team if the issue involves a vendor relationship.
III. Updates any remaining required fields in the eQMS prior to final QA approval of the investigation.
IV. Determines if the issue should be reported to Quality Assurance Review of Investigators (QA-RI) in accordance with CS_OP_QA0232 Investigator Compliance Status and Management of Investigators with Non-Compliance Issues
II and IV
It contains Inspection Management Checklists, training slide decks, system navigation guides for Inspectors, example documents, non-eSOP forms/templates
Inspection Management toolbox
Which of the following statements is/are correct about Quality Issue?
a. Represents a repeated or resolvable site non-compliance where previous mitigation plans could not bring the site back into compliance and/or where the monitor did not proactively identify and formally record the deficiencies.
b. May result in or has resulted in other regulatory authority or governmental agency enforcement action
c. Does not have the potential to significantly affect subject rights, subject safety, data integrity and/or the scientific validity of the studies
d. B & C
e. A & B
B. May result in or has resulted in other regulatory authority or governmental agency enforcement action
Which statement is true:
A. Never lie, give false information, or guess the answer to a specific question.
B. It is better to admit not knowing or forgetting than to give an answers that is later determined to be correct.
A. Never lie, give false information, or guess the answer to a specific question.
Which character delivered the line: "I don't have time for this, I have a bride to kill. So if you'll excuse me"
Emilia Ardiente-Torillo
Which statement is not true:
A. For Inspections that include a project electronic TMF (eTMF) in the scope, arrange to “lock/ freeze” the eTMF or take steps to halt project team / Records & Information Management action in the eTMF to prevent changes to the eTMF from taking place during the Inspection Time.
B. For Inspections that include a paper TMF, arrangements should be made to prevent changes from taking place during the Inspection period.
A. For Inspections that include a project electronic TMF (eTMF) in the scope, arrange to “lock/ freeze” the eTMF or take steps to halt project team / Records & Information Management action in the eTMF to prevent changes to the eTMF from taking place during the Inspection Time.
What does PRAC mean?
Pharmacovigilance risk assessment committee