Type
Word Search
Description

This word search contains the following answers:

Warning Letter
Standard
SOP
Specification
Quality
Gowning
Observation
Mislabeling
Escalation
Documentation
Curriculum
Procedures
Work Instructions
Recall
Training
Lot Number
Manufacturing
Audit
ALCOA
Complaints
Recipe
Batch Record
Validation
Calibration
Qualification
CAPA
Root Cause

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Quality Bingo

Type
Bingo Cards
Description

These bingo cards contain the following answers:

COMPLIANCE
GMP
DOCUMENTATION
REGULATION
CONTAMINATION
INDUCTION
BATCH RELEASE
RISK ASSESSMENT
EUDRALEX
CAPA
DEVIATION
VALIDATION
APPROVE
REVIEW
TRAINING
GDP
AUDIT
CALIBRATION
CHANGE CONTROL
EVALUATE
INSPECTION
Guidelines
SOP
POLICIES

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Good Manufacturing Practice (GMP) Crossword

Type
Crossword
Description

This crossword contains the following questions and answers:

A system for ensuring that products are consistently produced and controlled according to quality standards, designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product Good Manufacturing Practice
The "c" in cGMP stands for "_____," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation Current
Planned and systematic activities implemented in a quality system so that quality requirements for a product will be fulfilled Quality Assurance
The FDA applies cGMP regulations on a _______ scale. Sliding
A document issued by QA that confirms that a product meets its specification. Certificate of Analysis
Version controlled templates or instructions for the manufacturing process MBR
A solution meant to reduce or eliminate the cause of a detected nonconformity or other undesirable situation Corrective Action
An action taken to remove or improve a process to prevent potential future occurences of a nonconformance Preventive
A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. (21 CFR 210.3) Batch
All operations involved in the preparation of a product, from receipt of materials, Production
an environment, typically used in manufacturing, that has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size Cleanroom
a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations SOPs
This group's mission is to ensure "quality and efficiancy, while supporting regulatory compliance, in the development and manufacture of clinical trial investigational products at MSK IPQA
One of the functions of this group is to accept or reject each batch or lot based on review of the completed manufacturing records Quality Control
A practice that ensures concision, legibility, accuracy, authenticity, and traceability of all development, production, and testing activity records GDP
A hierarchical set of MSK policies and procedures, documented in SOP format, describing institutional cGMP compliance Manufacturing Quality System
An inspection to check for GMP compliance Audit
A departure from standard procedures or specifications resulting in non-conforming material &/or processes, or where there have been unusual or unexplained events which have the potential to impact on product quality, system integrity or personal safety Deviation
The document used for each individual batch of API, based on the master production instruction BPR
A formal monitoring system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validation status of a system or process and cause corrective action, if any, to be taken that will ensure that the system or process retains, or is placed back into a validated state of control Change Control
All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of products and the related controls Manufacture
The non-fulfilment of a specified “material/product” requirement – (usually to a specification) that usually leads to rejection or reworking of the item Nonconformance
A finished product or raw material test result that falls outside approved, registered or official specifications or acceptance criteria. If validated it results in a Non-conforming product. OOS
The basic cause of a deviation, from which effective actions can be defined to prevent recurrence Root Cause
Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results Validation
___________ validation is the process by which it is established, by laboratory studies, that the performance characteristics of the analytical methods meet the requirements for the intended application Method
A section in an Investigational New Drug (IND) application describing the composition, production, and controls of the drug substance and product (21 CFR 312.23(a)(7)) CMC
Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product API
The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength, and purity. Quality

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Quality Crossword Word Search

Type
Word Search
Description

This word search contains the following answers:

STRATEGY
REPORTS
PROCEDURES
DEFECTS
MANAGEMENT
WASTE
TRENDS
TEAM
SUPPLIERS
RISK
NONCONFORMITY
FEEDBACK
DEVIATION
CONTINUOUS IMPROVEMENT
CULTURE
AUDIT
ASSURANCE
CALIBRATION
JANKEL
DOCUMENTATION
TRACEABILITY
ENVIRONMENT
QUALITY
ISO STANDARDS

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QUALITY BINGO

Type
Bingo Cards
Description

These bingo cards contain the following answers:

COMPLIANCE
SOP
TRAINING
GMP
DOCUMENTATION
CONTAMINATION
REGULATION
INDUCTION
BATCH RELEASE
RISK ASSESSMENT
DMS
EUDRALEX
CAPA
DEVIATION
VALIDATE
APPROVE
REVIEW
ACCURACY
OOS
INSPECTION
POLICY
PQS
AUDIT
SAFETY

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DATA INTEGRITY CROSSWORD PUZZLE

Type
Crossword
Description

This crossword contains the following questions and answers:

representation of facts data
secure, computer-generated, time stamped electronic record audit trail
set of related data items treated as unit records
original records raw data
an exact verified copy of an original record true copy
clear and readable legible
agency of the U.S federal government FDA
restrictive regulatory
systematic and independent examination of records audit
term used to define manipulation of data breach
system of moral principles ethics
system for ensuring products are consistently produced & controlled according to standards GMP
step by step instructions to carry out the operations SOP
This is needed to ensure data integrity Quality culture
European Medicines Agency EMA
complete data accurate
certified copies original
procedure of preparing, reviewing, approving, issuing, recording, storing & archival of any document GDP
data about data meta data
acronym used to describe data integrity ALCOA
extent to which all data are complete, consistent & accurate throughout data life cycle data integrity
act of following regulations compliance
record or report document
data able to track all changes attributable
this is divided into 50 titles cfr
a set of specification for application dossier for the registration of Medicines and designed to be used across Europe CTD
Equivalent of the FDA in UK MHRA

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QUALITY SYSTEM ELEMENTS Word Search

Type
Word Search
Description

This word search contains the following answers:

Audits
Calibration
CAPA
Compliance
Improvements
Customer Satisfaction
Documentation
Incoming Inspection
Monitoring
Pride
Process Controls
Quality Engineering
Regulations
Specifications
Standards
Teamwork
Testing

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Lab Week Bingo Cards

Type
Bingo Cards
Description

These bingo cards contain the following answers:

Mislabeled
Hematology
Chemistry
Microbiology
Phlebotomy
Pathology
Cytology
Blood Bank
Vacutainer
RBC
LabCoat
WBC
Processing
STAT
Syringe
Blood Culture
Gloves
Sharpie
Gauze
QC
Calibration
Critical
Routine
ASAP

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Research Methods Crossword

Type
Crossword
Description

This crossword contains the following questions and answers:

Section of a research paper that discusses the literature used and is organized through themes Literature Review
Section of a research paper that introduces the topic and tells of its importance introduction
Type of sampling sometimes known as grab, accidental, or opportunity sampling Convenience
Sampling used for hard-to-reach populations snowball
A condition to causality where the IV comes before DV Time Order
Results when a scale produces consistent results Reliability
Part of the methods sections that explains how to go about collecting data Procedure
Also known as a questionnaire Survey
Data that is open ended, in-depth, and insight-oriented Qualitative
This has to be present in an experiement Intervention
Level of measurement where distance has no meaning Interval
Type of survey involving closed ended questions with forced choices Structured
Observation where researchers remains apart from the observed Pure
People tend to change behavior when they know they are being observed Reactivity
Data that is consistent and standardized and uses large samples in its research Quantitative
Type of criterion validity that has the ability to predict future events Predictive
Only chance determines which elements will make it into the sampe Random

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HEALTH INFORMATION PROFESSIONALS WEEK Word Search

Type
Word Search
Description

This word search contains the following answers:

ADMISSION
APPOINTMENTS
ASSESSMENTS
AUDIT
CHART
DISCHARGE
DOCUMENTS
EZ GRAPHS
FILE
FORMS
HEALTHCARE
INFORMATION
LABS
MEETINGS
ORDERS
ORGANIZE
PAPERWORK
PROCEDURES
RECORDS
REPORTS
RESIDENTS
SCAN
TRANSFERS
WEIGHTS

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Quality Wordsearch

Type
Word Search
Description

This word search contains the following answers:

COMPLIANCE
REQUIREMENT
SPECIFICATION
PROCEDURE
DEFECT
QUALITY
AUDIT
COMPLAIN
STANDARD
IMPROVE
SUPPLIER
SATISFY
CUSTOMER

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