I edit QD documents. I can initiate or terminate Review workflows. I am usually the first signature of approval.
Who is the Author?
100
The system that is used to track the US Q&C Scheduled and Completed Training
What is Le@rn?
100
This certification scheme for pharmaceutical excipients includes:
- GMP and GDP standards suitable for third-party auditing
- Definition of auditor competency
- Rules for third-party audit organizations
What is EXCiPACT?
100
Sharya Sandiford and Mildred Gauthier-Lopez
Who is Internal and External Auditing?
100
This is the form used to alert Global Quality of potential quality issues at the Affiliate level
What is a Rapid Quality Notice (RQN)?
200
This is the Role in QDMS that has the ability to initiate Approval and Obsolete approval workflows.
Who is the Coordinator?
200
I create courses in Le@rn and can view training histories for everyone in the organization I support.
Who is the TAPA?
200
This GMP Standard for Pharmaceutical Excipients is being developed by the NSF Joint Committee on Pharmaceutical Excipients and will be issued as an ANSI standard.
What is NSF/IPEC 363?
200
Missing systems, fraud, a pattern in the same or multiple systems
What is an audit observation?
200
This quality report is completed by each affiliate annually
What is the Affiliate Quality Review?
300
This document must always be governed by another QD. It cannot be a standalone document.
What is an (SD) Supporting Document?
300
Create courses in Le@rn, Maintain Q&C Curriculum, and Discontinue Courses
What are responsibilities of the TAPA?
300
Advantages of this include:
- clearly defined requirements
- improved compliance
- complete assessment by Certifying Body
- expense minimization
What is GMP certification standard?
300
A comment, observation, and/or recommendation, report, responses and corrective actions.
What is in an audit?
300
Name a third party contractor who is managed by Quality Systems.
What is BMS, Prasco, Impax, Teva or UCB?
400
This individual receives weekly notifications for major document status changes. This role is also the main point of contact if the document author has changed department’s or has left the company. This should be the initial point of contact when new or infrequent QDMS users need assistance.
Who is the QD Custodian?
400
I am responsible for the courses within the curriculum. I provide timely updates to the TAPA when courses or resources change.
Who is the US Q&C Team Manager
400
This free biweekly newsletter that can be subscribed to at ipecamericas.org.
What is the IPEC-Americas Insider?
400
For Cause, GXP, and New or re-qualified Facilities
What are audit types?
400
Name the two groups/roles that are responsible for completing the quality alert form that is sent to Global Quality.
What is the senior management of Quality Systems and the impacted group.
500
This check is due every two years on effective QDs. The workflows are initiated six months before the due date.
What is the Periodic Review?
500
This sequence of information entered into Le@rn uses an employee’s role to determine which group of employees will be registered for a US Q&C Curriculum Course.
What is a (pRule) prescriptive Rule?
500
This database is used for global third-party (supplier) audit coordination.
What is Phenix?
500
PAI, Mock Inspections, Due Diligence, Monitor Quality Performance Indicators
What is Internal & External Auditing?
500
The number of different product platforms supported by Quality Systems?