The Power of Experience!

Upcoming Events
Date Title Location Presenter/Table
11/2018 PDA Southeast Fall Conference Raleigh, NC  

Past Events
Date Title Location Presenter

NEXUS ‘170 Barcelona, Spain Charles Lankford: Quality Assurance Considerations for Cloud Based Track & Trace Systems

Quality in the Triangle Conference Raleigh, NC  Charles Lankford: Organization of the Quality Unit in BioPharma
6/26/2013 How Do We Validate the use of Cloud Technology DIA 2013
Boston, MA
Charles Lankford
4/10/2013 Optimizing Validation / Mapping Studies for GMP Complaince Webcast Charles Lankford
6/23/2011 Vendor Qualification Audits for SaaS Suppliers
Presentation DIA 2011 Annual Meeting
McCormick Place, Chicago, IL Charles Lankford, Session Chair and Presenter
10/30/2010 LIMS Validation; Best Practices for Compliance at Implementation and Beyond
FDANews Webinar Paul Krason
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
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
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, PA 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, PA 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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