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Presentations by G. Raymond Miller, Ph.D., President, MRC |
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2009 |
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10-05-09
10-06-09 |
Validation of Computer Systems
Costa Mesa, CA |
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The Center for Professional Innovation and Education |
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09-16-08
09-17-08 |
Validation of Computer Systems
Dublin, Ireland |
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The Center for Professional Innovation and Education |
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07-13-09
07-14-09 |
Validation of Computer Systems
Malvern, PA |
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The Center for Professional Innovation and Education |
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04-20-09
04-21-09 |
Validation of Computer Systems
Costa Mesa, CA |
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The Center for Professional Innovation and Education |
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03-16-09
03-17-09 |
Validation of Computer Systems
Berlin, Germany |
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The Center for Professional Innovation and Education |
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02-26-09
02-26-09 |
Validation of Computer Systems
(Custom training in the USA for a medical device/pharmaceutical
company) |
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The Center for Professional Innovation and Education |
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01-29-09
01-30-09 |
Validation of Computer Systems
Malvern, PA |
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The Center for Professional Innovation and Education |
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2008 |
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09-22-08
09-23-08 |
Validation of Computer Systems
Costa Mesa, CA |
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The Center for Professional Innovation and Education |
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07-21-08
07-22-08 |
Validation of Computer Systems
Malvern, PA |
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The Center for Professional Innovation and Education |
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05-22-08
05-23-08 |
Validation of Computer Systems
Dublin, Ireland |
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The Center for Professional Innovation and Education |
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04-28-08
04-29-08 |
Validation of Computer Systems
Costa Mesa, CA |
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The Center for Professional Innovation and Education |
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01-28-08
01-29-08 |
Validation of Computer Systems
Malvern, PA |
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The Center for Professional Innovation and Education |
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2007 |
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10-22-07
10-23-07 |
Validation of Computer Systems
Dublin, Ireland |
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The Center for Professional Innovation and Education |
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09-27-07
09-28-07 |
Validation of Computer Systems
Malvern, PA |
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The Center for Professional Innovation and Education |
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05-16-07
05-17-07 |
Validation of Computer Systems
(Custom training in the USA for a medical device/pharmaceutical
company) |
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The Center for Professional Innovation and Education |
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04-30-07
05-01-07 |
Validation of Computer Systems
Irvine, CA |
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The Center for Professional Innovation and Education |
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01-22-07
01-23-07 |
Validation of Computer Systems
Malvern, PA |
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The Center for Professional Innovation and Education |
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2006 |
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10-31-06
11-01-06 |
Validation of Computer Systems
Dublin, Ireland |
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The Center for Professional Innovation and Education |
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10-10-06
10-11-06 |
Validation of Computer Systems
(Custom training in Norway for a medical device company) |
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The Center for Professional Innovation and Education |
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09-25-06
09-26-06 |
Validation of Computer Systems
Malvern, PA |
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The Center for Professional Innovation and Education |
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03-29-06 |
Applying Risk Analysis to Validation Testing |
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1:30pm EST |
FDA News Audio Conference |
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Before 2006 |
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10-19-04 |
Practical Approaches
to DQ/IQ/OQ/PQ for Lab Instruments |
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SWE, Inc. - Laboratory
Instrument Qualification & Systems Validation Conference
San Diego, CA |
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10-18-04 |
Key Lessons from
Recent FDA Warning Letters |
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SWE, Inc. - Laboratory
Instrument Qualification & Systems Validation Conference
San Diego, CA |
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04-27-04 |
Using Wireless Communications in the FDA-Regulated Environment |
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ISA - Automation West Conference
Long Beach, CA |
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04-26-04
04-27-04 |
Track Chair: Automation in Food and Pharmaceuticals Industry
Session Chair: Plant Design & Instrumentation |
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ISA - Automation West Conference
Long Beach, CA |
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02-26-04 |
Applying Risk Analysis to Validation Testing |
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1:30pm EST |
FDA News Audio Conference |
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12-10-03 |
The Use of the V-Model
and Variations from GAMP 4 for Process Controls Systems |
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ISA - 21 CFR 11 & GMP Compliance
Technical Conference
San Jose, CA |
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12-09-03 |
Where is
Part 11 Heading? |
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ISA - 21 CFR 11 & GMP Compliance
Technical Conference
San Jose, CA |
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11-25-03 |
Applying Risk Analysis to Validation Testing |
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1:30pm EST |
FDA News Audio Conference |
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| 11-05-03 |
Part 11 Overview: Most
Recent Interpretation! |
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ISA -
CSC: 21 CFR Part 11 - Procedural and Technology Requirements
Research Triangle Park, NC |
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| Winter 03 |
Why the US FDA is
Rethinking 21 CFR Part 11 and What We Can Do Now |
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European
Pharmaceutical Contractor magazine |
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| 09-24-03 |
Where is 21 CFR Part 11 Headed? What
should We Do Now? |
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ISA - Computer System Compliance Conference -
Philadelphia, PA |
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| 09-11-03 |
Improving
Throughput In Validation Testing |
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InnaPhase - User Group Meeting - Las Vegas, NV |
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09-08-03
through
09-12-03 |
Tabletop Exhibit:
Featuring the WaveGenerator Chromatography Simulator system,
the best solution for generating simulated
chromatography for training and validation testing. And using the Wave Generator along with chromatography test scripts
for improved testing throughput. |
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InnaPhase - User Group Meeting - Las Vegas, NV |
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| 08-26-03 |
Where is 21 CFR Part 11 Headed? What
should We Do Now? |
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ISA - Computer System Compliance Conference -
Research Triangle Park, NC |
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| 07-29-03 |
Adapting to 21 CFR Part
11 "Enforcement Discretion" in the Laboratory |
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CPT -
Risk-Based Approaches to Part 11 |
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| 06-06-03 |
The Use of the V-Model
and Variations from GAMP 4 for Process Controls Systems |
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ISA -
Process Controls Conference - Philadelphia, PA |
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| 06-05-03 |
Where is 21 CFR Part 11
Headed? What Should We Do Now? |
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ISA -
Process Controls Conference - Philadelphia, PA |
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| 04-23-03 |
Where is Part 11 Headed:
Fundamental Issues That Aren't Going Away |
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San
Francisco Area ASQ Biomedical Discussion Group |
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| 03-21-03 |
Outsourcing 21 CFR Part
11 Remediation |
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Pharmaceutical Contracting Services and Outsourcing Expo (INTERPHEX) |
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| 02-18-03 |
Issues Associated with
the Storage of e-Records |
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DIA - 8th
Annual Computer Validation Conference |
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| 01-15-03 |
The Use of the V-Model
and Variations from GAMP 4 for Process Controls Systems |
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ISA -
GAMP Conference, Using the GAMP Model for cGMP Compliance |
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| 12-03-02 |
Electronic Copies Draft
Guidance: Impact on Part 11 Compliance |
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FDA News
Audio Conference |
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11-06-02 |
21 CFR Part 11
Roundtable:
Why the Integrity of Data in Drug Discovery will be
Paramount in the Future |
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Healthcare Opportunities - Maximizing Outcomes in IT |
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| 09-11-02 |
Improving Test Cases for
LIMS Validation |
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Beckman -
Coulter User Group Meeting, Seattle, WA |
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| 07-10-02 |
Computer System
Validation Workshop (two days) |
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Cetan
Validation Seminars |
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| 12-06-01 |
Current
US-FDA Expectations for Computer System Validation |
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Taisai
Seminar - Osaka, Japan |
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| 12-04-01 |
Current
US-FDA Expectations for Computer System Validation |
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Taisai
Seminar - Tokyo, Japan |
