Compliance and Validation Services

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Publications by PharmaSys Personnel

Upcoming Presentations
Date Title Location Presenter
10/21/2008 Validation of EDC
DIA Data Driven Drug Deveopment Conference, Ljubjana, Slovenia
Ljubljana, Slovenia Charles Lankford
9/8/2008 Computerized Systems in Clinical Research:Current Quality and Data Integrity Concepts
DIA conference to develop a useful reference for computerized systems in clinical research
DIA Headquarters, Horsham, PA Matthew Tedder, contributor to Chapter 17

Industry Publications
Date Title Location Presenter
7/22/2008 RNA Therapeutics
Bringing the Future of Biological and Medical Innovation to Today
Boston, MA Barry Crawford, Ph.D.
4/14/2008 PDA Annual Meeting
Poster – “A Risk Based Approach To Validation”
Colorado Springs, CO Brian Yancey
3/26/2008 Fundamentals of Cleaning Validation
Interphex Conference
Philadelphia PA Kris Kelly
3/17/2008 23rd Annual DIA Data Management in Transition: Putting the “e” in Data Management
Validating Electronic Data Capture Systems
Washington, DC Wyetta Palmby
3/8/2007 Qualification of a Mass Spectrometer System: A Case Study
Philadelphia, PA Chris Haskett
10/29/2006 PDA Microbiology Forum
Bethesda, MD Nancy Tomoney
5/17/2006 Validation of Bioreactors in a Biological Production Facility
To comply with regulatory requirements a company must validate bioreactors as well as the steps used to manufacture biological products
Web Seminar Charles Lankford & Brett Yates
4/24/2006 PDA National Meeting
Designing and Using Formal Annual Environmental Monitoring Reports to Discuss Annual Performance of Utility Systems
Anaheim, CA Nancy E. Tomoney
4/24/2006 PDA Annual Meeting
Validation of Bioreactors in a Biological Manufacturing Facility
Anaheim, CA Charles Lankford
3/31/2006 IVT
The When, Where, Why and How Often of Filter Validation
San Francisco, CA Nancy E. Tomoney
3/29/2006 IVT
Validation of Analytical Laboratory Equipment and Support Systems
San Francisco, CA Nancy E. Tomoney
3/28/2006 IVT
Aseptic Processing & Sterile Processes
San Francisco, CA Nancy E. Tomoney
3/22/2006 DIA - Follow-up to the Red Apple Conference
Computerized Systems for Nonclinical Safety Assessment:: Current Concepts and Quality Assurance
Horsham, P.A. Charles Lankford
3/21/2006 Interphex
Techniques for Running a Lean Commissioning / Validation Project
New York City, NY Charles Lankford
3/1/2006 PDA Metro Chapter Meeting
Qualification of Pharmaceutical Water Systems
Clark, NJ Nancy E. Tomoney
6/27/2005 IPQC
Analytical Instrument Qualification
Philadelphia, Pa Nancy Tomoney
3/15/2005 Lab Equipment Validation and Qualification
Strategies for validation and qualification of lab instruments and computer systems to ensure optimal compliance.
Brussels, Belgium Charles Lankford
3/7/2005 Lab Equipment Validation and Qualification
Strategies for validation and qualification of lab instruments and computer systems to ensure optimal compliance.
Philadelphia, Pa Charles Lankford
2/1/2005 IT Infrastructure Qualification Conference
Creating and Maintaining a Compliant Network Infrastructure in a Small-Mid Cap Company
Las Vegas, NV Matt Tedder
12/4/2004 Barnett International
Identifying Regulatory Requirements and Developing a Project Plan to Implement a Successful Environmental Monitoring Program
Philadelphia, Nancy Tomoney
11/18/2004 IVT
Developing and Executing Microbial Cleaning Validation Protocols to Comply with FDA Requirements.
Amsterdam, The Netherlands Nancy Tomoney
11/16/2004 IVT
Cleaning Validation Mistakes: How Not to Perform Cleaning Validation: A Review of Regulatory Citations and Solutions to Avoid Making the Same Mistake.
Amsterdam, The Netherlands Nancy Tomoney
9/13/2004 Barnett International
Successfully Validating Compendial Water Systems- Establishing Microbial Control
Philadelphia, PA Nancy Tomoney
6/16/2004 DIA 40th Annual Meeting
Validating Clinical Data Systems
Washington, DC Charles Lankford
6/10/2004 PDA Audio Conference
FDA's New Barcode Requirement When, Where and How to Comply
Audio Conference Hal Sanborn
5/17/2004 Center for Professional Advancement
Computer Validation (Manufacturing)
Boca Raton, Fl
3/15/2004 Center for Professional Advancement
GLPs and Part 11
San Francisco, CA
3/11/2004 DIA 9th Annual Computer Validation Conference:
Computer Automated Testing Tools Regulatory and Validation Impacts
Arlington, VA Matthew Tedder
2/10/2004 Center for Professional Advancement
GLPs and Part 11
Boca Raton, Fl
1/12/2004 Center for Professional Advancement
Computer Validation (R&D)
San Francisco, CA
11/11/2003 Barnett International
Validation / Risk and Maintenance System
Brussels, Belgium
11/11/2003 2003 PDA Annual Meeting
Computer Automated Testing Tools Regulatory and Validation Impacts
Atlanta, GA Matthew Tedder
10/27/2003 Center for Professional Advancement
Topic Computer Validation (R&D)
New Brunswick, NJ
8/28/2003 The SMi Group
Validation of Clinical
London, England UK Jeffery Taylor
8/1/2003 Barnett International
Validation of Building Management Systems
Philadelphia, Pa. Chris Haskett
6/24/2003 Barnett International
Developing Concise Software Validation Master Plans
Philadelphia, Pa Jeffery Taylor
3/17/2003 Barnett International
Understanding 21 CFR Part 11 Remediation for Legacy Systems
Philadelphia, Pa. Matthew Tedder

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