![]() |
![]() |
|
|
|
Publications
by PharmaSys Personnel
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Upcoming Presentations | |||
| Date | Title | Location | Presenter |
| Industry Publications | |||
| Date | Title | Location | Presenter |
| 6/16/2010 | Validating Clinical Applications in the Cloud |
DIA 46th Annual Meeting Walter E. Washington Convention Center | Charles Lankford |
| 6/25/2009 | Tools and Techniques for Validating Open Source Systems |
DIA 45th Annual Meeting San Diego Convention Center | Wyetta Palmby |
| 4/22/2009 | Clean-In-Place (CIP) & Sterilize-In-Place (SIP) Systems in the Biopharmaceutical Industry, Improving Process Reliability through Computerization Presentation |
2009 PDA Annual Meeting | Charles Lankford |
| 3/30/2009 | Cleaning Validation Fundamentals The "What,Why, and When" of Cleaning Validation |
Hilton Raleigh-Durham at Research Triangle Park | TBD |
| 10/28/2008 | Poster: Implementing and Maintaining an Effective Quality Management System Explaining the keys to a successful QMS and the basics of implementaion and maintenance. |
ISPE 08 Annual Meeting | Wyetta Palmby and Charles Lanford |
| 10/28/2008 | Poster: Thermal Validation Systems Covers the topic of choosing the right Thermal Validation System, NIST traceability standards, 21 CFR Part 11 compliance, temperature controlled environments, common uses for Thermal Validation, and common manufacturers |
ISPE 08 Annual Meeting | Aqueelah Patterson & Charles Lankford |
| 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 |
| 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 |
Home Services Partners Careers Seminars Resources About Us
Audits Automation Cleaning Clinical Compliance Commissioning Computer Equipment/Facilities Solid Dosage Laboratory Process Thermal