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Employee: Lackey,Ronald T76365 Dept.: 17
Module: GHR-ISOTRAIN-OL-USER ISOtrain Online User Rev.: 0001
GHR-001198 ISOtrain Online: User (English)
(E-learning)
0001 TAKEN0001 23-Sep-2013 Y
GITCSF0007 TDTS Electronic Signature
Agreement
0000 TAKEN0000 23-Sep-2013 Y
Module: GM-01-CAPA-INIT-INV Required Training for CAPA Initial Investigators - MP Sites Rev.: 0000
CQP0702015 CORRECTIVE ACTION
PREVENTIVE ACTION (CAPA)
REQUIREMENTS
0004 TAKEN0004 06-Aug-2014 Y
CQP0703025 MEDICAL PRODUCTS
NONCONFORMANCE AND
CAPA PROCESS
MANAGEMENT
0000 TAKEN0000 03-Dec-2014 Y
GQUAL-CAPA-
INIT-INV
CAPA Initial Investigator
Training (English) (E-learning)
0000 TAKEN0000 22-Oct-2013 Y
GQUAL-CAPA-
OVERVIEW
CAPA Process Overview
(English) (E-learning)
0002 TAKEN0002 29-Oct-2013 Y
GQUAL-TW8-
CAPA-EI
(iKAT) Assessment for
Trackwise 8 CAPA Event
Initiator Role
0000 TAKEN0000 27-Nov-2013 Y
GQUAL-TW8-
CAPA-II
(iKAT) Assessment for
Trackwise 8 CAPA Initial
Investigator Role
0000 TAKEN0000 27-Nov-2013 Y
Module: GM-01-CAPA-INITIATOR Required Training for CAPA Event Initiators - MP Sites Rev.: 0000
CQP0702015 CORRECTIVE ACTION
PREVENTIVE ACTION (CAPA)
REQUIREMENTS
0004 TAKEN0004 06-Aug-2014 Y
CQP0703025 MEDICAL PRODUCTS
NONCONFORMANCE AND
CAPA PROCESS
MANAGEMENT
0000 TAKEN0000 03-Dec-2014 Y
GQUAL-CAPA-
OVERVIEW
CAPA Process Overview
(English) (E-learning)
0002 TAKEN0002 29-Oct-2013 Y
GQUAL-TW8-
CAPA-EI
(iKAT) Assessment for
Trackwise 8 CAPA Event
Initiator Role
0000 TAKEN0000 27-Nov-2013 Y
Module: GQUAL-HIPAA-OVERVIEW PMDA HIPAA Overview Rev.: 0000
GQUAL-HIPAA-
OVERVIEW
HIPAA Privacy and Global Field
Surveillance
0000 TAKEN0000 30-Oct-2013 Y
Module: GQUAL-NI-REQUIRED Required Training for Corporate Entity Rev.: 0005
GQUAL-000580 Good Manufacturing Practices
(GMP) (English) (E-Learning)
0005 TAKEN0005 23-Sep-2014 Y
GQUAL-001517 Good Documentation Practices
Basics (GDP) (English)
(E-learning)
0005 TAKEN0005 PD 24-Sep-2014 Y
NI03001 CORPORATE ENTITY
TRAINING
0006 TAKEN0006 23-Dec-2013 Y
Module: GQUAL-PCAEH Product Complaint and Adverse Event Handling Rev.: 0004
GQUAL-002028A Product Complaint & Adverse
Event Handling
0000 TAKEN0001 NR 09-Dec-2013 Y
Module: GQUAL-QMS-OVERVIEW Overview of the Baxter Quality Management System Rev.: 0001
GQUAL-001784 Introduction to the Quality
Management System
(E-learning)
0000 TAKEN0000 24-Sep-2013 Y
Req.CommentsSch ?QualifierDescriptionCourse Task Rev. Due
Rev.
Status
Baxter Healthcare Corporation
Employee Qualifications by Module
Date Range: 30-Mar-2015 - 30-Mar-2015
Date: 30-Mar-2015
Time: 3:35:35 PM
V
Server Time: 02:35:36 PM
92
Page 1 of 4
GQUAL-Q-POLICY Baxter Quality Policy 0000 TAKEN0000 23-Sep-2013 Y
Module: GQUAL-QTS-EXTAUDITEE QTS Audit External Workflow - Auditee Accounts Rev.: 0003
CQP0702003 External Inspection and Global
Enforcement Letter
Management
0004 TAKEN0004 05-Nov-2013 Y
CQP0703009 External Inspection and Global
Enforcement Letter Tracking
0001 TAKEN0001 31-Oct-2013 Y
GQUAL-001854 QTS Audit External Workflow -
Auditee Accounts (Main Contact
and Assignee) (English)
(E-learning)
0000 TAKEN0001 05-Nov-2013 Y
Module: GQUAL-QTS-INTAUDITEE QTS Audit Corporate Internal Workflow - Auditee Accounts Rev.: 0005
GQUAL-001851 QTS Audit Corporate Internal
Workflow - Auditee Accounts
(Main Contact and Assignee)
(English) (E-learning)
0000 TAKEN0001 07-Nov-2013 Y
Module: GQUAL-RM-AWARE Risk Management Awareness Rev.: 0000
GQUAL-001728 Risk Management Overview
(English) (E-learning)
0001 TAKEN0001 12-Nov-2013 Y
Module: UIL1-CQ-DOC-OWNER Corporate Quality Document Owner Staff Rev.: 0004
CQP0202003 Document Hierarchy 0010 TAKEN0010 23-Dec-2013 Y
CQP0203005 Document Change
Management
0008 TAKEN0008 23-Dec-2013 Y
DDM003 Document Change Package -
Submission
0000 TAKEN0000 10-Mar-2014 Y
Module: UIL1-CQ-EHS Corporate Quality Environmental, Health & Safety Rev.: 0001
P1S017 Facility Environment, Health
and Safety Awareness and
Training Procedure
0016 TAKEN0016 24-Sep-2013 Y
Module: UIL1-CQ-REQD Corporate Quality Core Training Requirements Rev.: 0009
1216428 Corporate Implementing
Document to the Baxter Quality
Manual
0004 TAKEN0004 24-Sep-2013 Y
CQM01 QUALITY MANAGEMENT
SYSTEM
0005 TAKEN0005 30-Mar-2015 Y
CQP0202001 Quality Record Retention 0008 TAKEN0008 17-Dec-2014 Y
GQUAL-001783 ISOtrain Online User
Compliance Requirements
(Primary Audience Northern IL;
may apply to other users)
0000 TAKEN0002 27-Sep-2013 Y
GQUAL-
BPLMNEWUSER
BPLM: Introduction and Basic
Concepts
0000 TAKEN0003 NR 23-Sep-2013 Y
Module: UIL1-GFS-FCA GFS FCA Staff Rev.: 0002
1102161 Recall Mailing List Tool User
Guide - Including Class
Code/Reporting Class Additions
& Changes & Installation Recall
Master
0003 TAKEN0004 25-Sep-2013 Y
1154899 U.S. Field Corrective Action
(FCA) Implementation
0018 TAKEN0018 08-Dec-2014 Y
1223092 U.S. Product Hold Procedure 0004 TAKEN0004 10-Oct-2013 Y
1226432 USE OF STERICYCLE FOR
THE FCA PROCESS
0001 TAKEN0001 26-Sep-2013 Y
1242663 CORPORATE QUALITY FCA -
MANAGING CUSTOMER
COMMUNICATION
0004 TAKEN0004 30-Sep-2013 Y
Req.CommentsSch ?QualifierDescriptionCourse Task Rev. Due
Rev.
Status
Baxter Healthcare Corporation
Employee Qualifications by Module
Date Range: 30-Mar-2015 - 30-Mar-2015
Date: 30-Mar-2015
Time: 3:35:35 PM
V
Server Time: 02:35:36 PM
92
Page 2 of 4
COMMUNICATION
CQP0302010 RETURNED PRODUCT 0001 TAKEN0003 NR 06-Aug-2014 Y
CQP0303010 PRODUCT HOLDS 0002 TAKEN0002 18-Dec-2013 Y
CQP0503006 CE Marking of Medical Devices 0003 TAKEN0003 13-Nov-2013 Y
CQP0602001 PRODUCT LABELING
CONTROL
0002 TAKEN0003 13-Nov-2013 Y
CQP0703004 GLOBAL FIELD CORRECTIVE
ACTION (FCA) PROCESS
0008 TAKEN0008 06-Mar-2015 Y
CQP0703014 GLOBAL FIELD ALERT
PROCEDURE
0004 TAKEN0004 03-Dec-2014 Y
Module: UIL1-GFS-REQUIRED Global Field Surveillance Staff Rev.: 0006
1266017 MATRIX FOR COMPLAINT
AND SAFETY REPORTING
RESPONSIBILITY FOR
FINISHED GOODS,
CATEGORY B
0000 TAKEN0000 13-Feb-2015 Y
CQP0503038 QUALITY RISK MANAGEMENT 0000 TAKEN0000 27-Dec-2014 Y
CQP0702003 External Inspection and Global
Enforcement Letter
Management
0004 TAKEN0004 05-Nov-2013 Y
CQP0702005 IDENTIFYING AND
REPORTING COMPLAINT
INFORMATION
0006 TAKEN0006 06-Dec-2013 Y
CQP0702014 IDENTIFYING AND
REPORTING ADVERSE
EVENTS AND OTHER
INFORMATION REQUIRED BY
PHARMACOVIGILANCE
0001 TAKEN0001 ABS 03-Dec-2014 Y
CQP0703004 GLOBAL FIELD CORRECTIVE
ACTION (FCA) PROCESS
0008 TAKEN0008 06-Mar-2015 Y
CQP0703008 Tier I Corrective and
Preventative Action (CAPA)
Nonconformance Management
0003 TAKEN0004 NR 15-Nov-2013 Y
TAKEN: 51
EQUIV: 0
MISSING: 0
FR: 0
REVISION: 0
RETRAIN: 0
Qual: 100.00%
ITP: 100.00%
Total Courses: 51
Req.CommentsSch ?QualifierDescriptionCourse Task Rev. Due
Rev.
Status
Baxter Healthcare Corporation
Employee Qualifications by Module
Date Range: 30-Mar-2015 - 30-Mar-2015
Date: 30-Mar-2015
Time: 3:35:35 PM
V
Server Time: 02:35:36 PM
92
Page 3 of 4
***End Of Report***
Req.CommentsSch ?QualifierDescriptionCourse Task Rev. Due
Rev.
Status
Baxter Healthcare Corporation
Employee Qualifications by Module
Date Range: 30-Mar-2015 - 30-Mar-2015
Date: 30-Mar-2015
Time: 3:35:35 PM
V
Server Time: 02:35:36 PM
92
Page 4 of 4

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Baxter Training

  • 1. Employee: Lackey,Ronald T76365 Dept.: 17 Module: GHR-ISOTRAIN-OL-USER ISOtrain Online User Rev.: 0001 GHR-001198 ISOtrain Online: User (English) (E-learning) 0001 TAKEN0001 23-Sep-2013 Y GITCSF0007 TDTS Electronic Signature Agreement 0000 TAKEN0000 23-Sep-2013 Y Module: GM-01-CAPA-INIT-INV Required Training for CAPA Initial Investigators - MP Sites Rev.: 0000 CQP0702015 CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) REQUIREMENTS 0004 TAKEN0004 06-Aug-2014 Y CQP0703025 MEDICAL PRODUCTS NONCONFORMANCE AND CAPA PROCESS MANAGEMENT 0000 TAKEN0000 03-Dec-2014 Y GQUAL-CAPA- INIT-INV CAPA Initial Investigator Training (English) (E-learning) 0000 TAKEN0000 22-Oct-2013 Y GQUAL-CAPA- OVERVIEW CAPA Process Overview (English) (E-learning) 0002 TAKEN0002 29-Oct-2013 Y GQUAL-TW8- CAPA-EI (iKAT) Assessment for Trackwise 8 CAPA Event Initiator Role 0000 TAKEN0000 27-Nov-2013 Y GQUAL-TW8- CAPA-II (iKAT) Assessment for Trackwise 8 CAPA Initial Investigator Role 0000 TAKEN0000 27-Nov-2013 Y Module: GM-01-CAPA-INITIATOR Required Training for CAPA Event Initiators - MP Sites Rev.: 0000 CQP0702015 CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) REQUIREMENTS 0004 TAKEN0004 06-Aug-2014 Y CQP0703025 MEDICAL PRODUCTS NONCONFORMANCE AND CAPA PROCESS MANAGEMENT 0000 TAKEN0000 03-Dec-2014 Y GQUAL-CAPA- OVERVIEW CAPA Process Overview (English) (E-learning) 0002 TAKEN0002 29-Oct-2013 Y GQUAL-TW8- CAPA-EI (iKAT) Assessment for Trackwise 8 CAPA Event Initiator Role 0000 TAKEN0000 27-Nov-2013 Y Module: GQUAL-HIPAA-OVERVIEW PMDA HIPAA Overview Rev.: 0000 GQUAL-HIPAA- OVERVIEW HIPAA Privacy and Global Field Surveillance 0000 TAKEN0000 30-Oct-2013 Y Module: GQUAL-NI-REQUIRED Required Training for Corporate Entity Rev.: 0005 GQUAL-000580 Good Manufacturing Practices (GMP) (English) (E-Learning) 0005 TAKEN0005 23-Sep-2014 Y GQUAL-001517 Good Documentation Practices Basics (GDP) (English) (E-learning) 0005 TAKEN0005 PD 24-Sep-2014 Y NI03001 CORPORATE ENTITY TRAINING 0006 TAKEN0006 23-Dec-2013 Y Module: GQUAL-PCAEH Product Complaint and Adverse Event Handling Rev.: 0004 GQUAL-002028A Product Complaint & Adverse Event Handling 0000 TAKEN0001 NR 09-Dec-2013 Y Module: GQUAL-QMS-OVERVIEW Overview of the Baxter Quality Management System Rev.: 0001 GQUAL-001784 Introduction to the Quality Management System (E-learning) 0000 TAKEN0000 24-Sep-2013 Y Req.CommentsSch ?QualifierDescriptionCourse Task Rev. Due Rev. Status Baxter Healthcare Corporation Employee Qualifications by Module Date Range: 30-Mar-2015 - 30-Mar-2015 Date: 30-Mar-2015 Time: 3:35:35 PM V Server Time: 02:35:36 PM 92 Page 1 of 4
  • 2. GQUAL-Q-POLICY Baxter Quality Policy 0000 TAKEN0000 23-Sep-2013 Y Module: GQUAL-QTS-EXTAUDITEE QTS Audit External Workflow - Auditee Accounts Rev.: 0003 CQP0702003 External Inspection and Global Enforcement Letter Management 0004 TAKEN0004 05-Nov-2013 Y CQP0703009 External Inspection and Global Enforcement Letter Tracking 0001 TAKEN0001 31-Oct-2013 Y GQUAL-001854 QTS Audit External Workflow - Auditee Accounts (Main Contact and Assignee) (English) (E-learning) 0000 TAKEN0001 05-Nov-2013 Y Module: GQUAL-QTS-INTAUDITEE QTS Audit Corporate Internal Workflow - Auditee Accounts Rev.: 0005 GQUAL-001851 QTS Audit Corporate Internal Workflow - Auditee Accounts (Main Contact and Assignee) (English) (E-learning) 0000 TAKEN0001 07-Nov-2013 Y Module: GQUAL-RM-AWARE Risk Management Awareness Rev.: 0000 GQUAL-001728 Risk Management Overview (English) (E-learning) 0001 TAKEN0001 12-Nov-2013 Y Module: UIL1-CQ-DOC-OWNER Corporate Quality Document Owner Staff Rev.: 0004 CQP0202003 Document Hierarchy 0010 TAKEN0010 23-Dec-2013 Y CQP0203005 Document Change Management 0008 TAKEN0008 23-Dec-2013 Y DDM003 Document Change Package - Submission 0000 TAKEN0000 10-Mar-2014 Y Module: UIL1-CQ-EHS Corporate Quality Environmental, Health & Safety Rev.: 0001 P1S017 Facility Environment, Health and Safety Awareness and Training Procedure 0016 TAKEN0016 24-Sep-2013 Y Module: UIL1-CQ-REQD Corporate Quality Core Training Requirements Rev.: 0009 1216428 Corporate Implementing Document to the Baxter Quality Manual 0004 TAKEN0004 24-Sep-2013 Y CQM01 QUALITY MANAGEMENT SYSTEM 0005 TAKEN0005 30-Mar-2015 Y CQP0202001 Quality Record Retention 0008 TAKEN0008 17-Dec-2014 Y GQUAL-001783 ISOtrain Online User Compliance Requirements (Primary Audience Northern IL; may apply to other users) 0000 TAKEN0002 27-Sep-2013 Y GQUAL- BPLMNEWUSER BPLM: Introduction and Basic Concepts 0000 TAKEN0003 NR 23-Sep-2013 Y Module: UIL1-GFS-FCA GFS FCA Staff Rev.: 0002 1102161 Recall Mailing List Tool User Guide - Including Class Code/Reporting Class Additions & Changes & Installation Recall Master 0003 TAKEN0004 25-Sep-2013 Y 1154899 U.S. Field Corrective Action (FCA) Implementation 0018 TAKEN0018 08-Dec-2014 Y 1223092 U.S. Product Hold Procedure 0004 TAKEN0004 10-Oct-2013 Y 1226432 USE OF STERICYCLE FOR THE FCA PROCESS 0001 TAKEN0001 26-Sep-2013 Y 1242663 CORPORATE QUALITY FCA - MANAGING CUSTOMER COMMUNICATION 0004 TAKEN0004 30-Sep-2013 Y Req.CommentsSch ?QualifierDescriptionCourse Task Rev. Due Rev. Status Baxter Healthcare Corporation Employee Qualifications by Module Date Range: 30-Mar-2015 - 30-Mar-2015 Date: 30-Mar-2015 Time: 3:35:35 PM V Server Time: 02:35:36 PM 92 Page 2 of 4
  • 3. COMMUNICATION CQP0302010 RETURNED PRODUCT 0001 TAKEN0003 NR 06-Aug-2014 Y CQP0303010 PRODUCT HOLDS 0002 TAKEN0002 18-Dec-2013 Y CQP0503006 CE Marking of Medical Devices 0003 TAKEN0003 13-Nov-2013 Y CQP0602001 PRODUCT LABELING CONTROL 0002 TAKEN0003 13-Nov-2013 Y CQP0703004 GLOBAL FIELD CORRECTIVE ACTION (FCA) PROCESS 0008 TAKEN0008 06-Mar-2015 Y CQP0703014 GLOBAL FIELD ALERT PROCEDURE 0004 TAKEN0004 03-Dec-2014 Y Module: UIL1-GFS-REQUIRED Global Field Surveillance Staff Rev.: 0006 1266017 MATRIX FOR COMPLAINT AND SAFETY REPORTING RESPONSIBILITY FOR FINISHED GOODS, CATEGORY B 0000 TAKEN0000 13-Feb-2015 Y CQP0503038 QUALITY RISK MANAGEMENT 0000 TAKEN0000 27-Dec-2014 Y CQP0702003 External Inspection and Global Enforcement Letter Management 0004 TAKEN0004 05-Nov-2013 Y CQP0702005 IDENTIFYING AND REPORTING COMPLAINT INFORMATION 0006 TAKEN0006 06-Dec-2013 Y CQP0702014 IDENTIFYING AND REPORTING ADVERSE EVENTS AND OTHER INFORMATION REQUIRED BY PHARMACOVIGILANCE 0001 TAKEN0001 ABS 03-Dec-2014 Y CQP0703004 GLOBAL FIELD CORRECTIVE ACTION (FCA) PROCESS 0008 TAKEN0008 06-Mar-2015 Y CQP0703008 Tier I Corrective and Preventative Action (CAPA) Nonconformance Management 0003 TAKEN0004 NR 15-Nov-2013 Y TAKEN: 51 EQUIV: 0 MISSING: 0 FR: 0 REVISION: 0 RETRAIN: 0 Qual: 100.00% ITP: 100.00% Total Courses: 51 Req.CommentsSch ?QualifierDescriptionCourse Task Rev. Due Rev. Status Baxter Healthcare Corporation Employee Qualifications by Module Date Range: 30-Mar-2015 - 30-Mar-2015 Date: 30-Mar-2015 Time: 3:35:35 PM V Server Time: 02:35:36 PM 92 Page 3 of 4
  • 4. ***End Of Report*** Req.CommentsSch ?QualifierDescriptionCourse Task Rev. Due Rev. Status Baxter Healthcare Corporation Employee Qualifications by Module Date Range: 30-Mar-2015 - 30-Mar-2015 Date: 30-Mar-2015 Time: 3:35:35 PM V Server Time: 02:35:36 PM 92 Page 4 of 4