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Webinar Recordings
Webinar Recording: Requirements: Your Foundation for Conducting Successful Computer System Validations
Recorded Tuesday, January 26, 2010
11:00 a.m.-12:00 p.m. Eastern Standard Time (United States)
Instructors: Jay King, Senior Manager, Software and New Product Quality, LifeScan, a Johnson & Johnson Company
John Janeri, President, Compliance House, Inc.
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Webinar Recording: Computer Validation Audits: A Primer for Successful Execution
Recorded Thursday, January 21, 2010
11:00am – 12:00pm -Eastern Daylight Savings Time-United States
INSTRUCTOR: Eric Henry, Senior Manager, Corporate Software Quality, Boston Scientific
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Webinar Recording-GLP – Effective Documentation and Study Reconstructability
Thursday, December 3, 2009
11:00 a.m.-12:00 p.m., Eastern Standard Time (United States)
Instructor: Celeste A. Rose, RQAP-GLP; GLP Subject Matter Expert
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Webinar Recording-The Seven Deadly Sins of Failure Investigations
Tuesday, December 8, 2009
11:00 a.m.-12:00 Noon, Eastern Standard Time (United States)
Eldon Henson, Director API products and R&D Quality, Covidien (formerly Mallinckrodt).
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Special 21 CFR Part 11 Webinar Recording Package
➢Purchase this Special Recording Package in our enKap Store
Special Webinar RECORDING package includes:
➢1. Webinar Recording - FDA Part 11 Inpections: A Primer for Successful Execution
➢2. Webinar Recording - Conducting Effective Internal/External Part 11 Audits: And Auditor Tells How
➢3. Webinar Recording - 21 CFR Part 11: A Primer for Implementing Audit Trail
Plus Bonus Material
➢Part 11 System Compliance Assessment Checklist
➢FDA Part 11 Inspections - Frequently Asked Questions and Answers
LIMITED TIME OFFER - OVER 50% DISCOUNT
FDA Enforcement Trends-GCP: A Primer for Preparing for 2010
Webinar Recording -21 CFR Part 11: A Primer for Implementing Audit Trail
Tuesday, November 3, 2009
10:45 a.m.-12:00 Noon, Eastern Standard Time (United States)
Instructor: Jasmin NUHIC, Senior Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert, Medtronic, Inc.
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Webinar Recording - Conducting Effective Internal/External Part 11 Audits: An Auditor Tells How
Tuesday, October 27, 2009
10:45 a.m.-12:00 Noon, Eastern Standard Time (United States)
Instructor: Jasmin NUHIC, Senior Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert, Medtronic, Inc.
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Webinar Recording - Basic Principles of Drug GMP: Meeting FDA Requirements
Thursday, October 22, 2009
10:00 a.m.-11:00 a.m., Eastern Standard Time (United States)
Instructor: John Stromp,former Manager Documentation, Regulatory and Compliance, GlaxoSmithKline
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Webinar Recording – Drug Enforcement Administration (DEA) Regulations: Basic Principles of Controlled Substances Compliance
Tuesday, October 13, 2009
10:00 a.m.-11:00 a.m., Eastern Standard Time (United States)
Instructor: John Stromp,former Manager Documentation, Regulatory and Compliance, GlaxoSmithKline
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Webinar Recording - FDA CAPA Inspections: A Primer for Successful Execution
Recorded Wednesday, October 7, 2009
11:00 a.m.-12:00 noon -Eastern Standard Time-United States
INSTRUCTOR: William McQuillan, Global Manager Change Document and Record Management and CAPA Subject Matter Expert, Cordis, a Johnson & Johnson Company
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Webinar Recording-Software Supplier Audits: It’s Not Just About Compliance
Recorded: Thursday, September 24, 2009
11:00am – 12:00pm -Eastern Standard Time-United States
Instructor - Eric Henry, Senior Manager, Corporate Software Quality, Boston Scientific
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WEBINAR RECORDING: GLP Amendments, Deviations and Unforeseen Circumstances: The Good, The Bad and The Ugly
Recorded: Thursday, September 17th, 2009
11:00 a.m. EST-12:00 noon -Eastern Standard Time-United States
INSTRUCTOR: Celeste Rose, RQAP-GLP, President/GLP Subject Matter Expert, RoseTECH Consulting, Inc.
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WEBINAR RECORDING:Change Control Hot Topics: FDA/Global Regulatory Inspections
Recorded: Tuesday, September 15th, 2009
11:00 a.m.-12:00 Noon, Eastern Standard Time (United States)
Instructor: Eldon Henson, Director API Products and R&D Quality
Covidien (formerly Mallinckrodt)
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Webinar Recording - FDA Part 11 Inspections: A Primer for Successful Execution
Recorded Tuesday, August 18, 2009
10:45 a.m.-12:00 Noon, Eastern Standard Time (United States)
Instructor: Jasmin Nuhic, Senior Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert
Medtronic, Inc.
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Webinar Recording - Complaint Handling: An Insider’s View of Effective Management Practice
RECORDING FROM:
Tuesday, June 23, 2009
11:00 a.m.-12:00 p.m Eastern Standard Time (United States)
Instructor: Eldon Henson Director, Quality for Pharmaceuticals and Research and Development
Covidien (formerly Mallinckrodt)
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WEBINAR Recording - CAPA: Implementing an Effective Program: Lessons From the Trenches
Recorded: Tuesday, June 16, 2009
11:00 a.m.-12:00 p.m Eastern Standard Time (United States)
Instructor: Will McQuillen
Global Manager, Change Document and Records Management
Cordis, a Johnson & Johnson Company
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Complete Event Schedule
Join the U.S. FDA and Major Pharma and Device Manufacturers who attend our events; Pfizer, Merck, Johnson & Johnson, AstraZeneca, Medtronic, Boston Scientific, Alcon, Schering-Plough, Roche, Bristol Myers Squibb, Becton Dickinson and more...
***SCHEDULE***
GLP LIVE Training Workshops - (click here for complete brochure)
Two GLP Workshops in Two Locations
1. The Brass Tacks of GLP: Practical Understanding of the Fundamentals As Never Before Explained
2. Writing Effective GLP Docments
March 9-10, 2010 San Diego
March 11-12, 2010 San Francisco by a GLP Subject Matter Expert
Medical Device Software Validation LIVE Training Workshops - (click here for complete brochure)
Two Workshops in Two Locations
1. Medical Device Software Validation: System Definition and Requirements: Incorporating Effectiveness and Compliance in Software Design
2. Implementing Critical Processes for Effectively Supporting Medical Device Software Validation Programs
March 24-25, 2010 Iselin, NJ
May 19-20, 2010 Waltham, MA by Boston Scientific
CAPA LIVE Training Workshops - (click here for complete brochure)
Two Workshops
1. CAPA: Effective System Management - One Industry Professional Shares His Expertise
2.Supplier-Related CAPA: Conducting Effective Root Cause Investigations
April 20-21, 2010 Boston/Waltham, MA
by a CAPA Subject Matter Expert
GMP LIVE Training Workshop: Master Production Batch Records - (click here for complete brochure)
Effective Generation and Control of Master Production Batch Records (MPBR)
April 22, 2010 Boston/Waltham, MA by a GMP Subject Matter Expert
May 12-13, 2010 Hilton Woodbridge-Iselin, NJ by a GMP Subject Matter Expert
To View Previously Recorded Webinars Click Here
Special 21 CFR Part 11 Recording Package - Click Here for More Details
Recent Webinar TESTIMONIALS:
"It was the perfect presentation for my audience. Over the last year, since I started retraining all my frequent fliers, I have gone over or flagged for action every concern in that presentation. I had people in the audience that needed a final re-enforcement. I believe every "hot-topic" in Change Control was covered". - Anuja Rajbhandari, Change Control Specialist - AstraZeneca - CLICK HERE TO VIEW THE WEBINAR ON CHANGE CONTROL
"Enjoyed it. It was like the trainer has worked at our facility!!" - Carol S. Spicer, Director, Quality, Training and Support Services - Bridge Laboratories - CLICK HERE TO VIEW THE WEBINAR ON GLP DEVIATIONS
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