FDA GMP Training for Drugs, Pharmaceuticals, Medical Devices and Dietary Supplements


Web Seminars

Upcoming Web Seminars
Scroll down to see upcoming and archived programs

 

We have conducted over 400 web seminars since 2004. We bring you top industry experts who focus their presentations on the How-to aspects of their topic. We've had thousands of people participate representing hundreds of companies around the globe.


 

Coming in
September 2008

 

Programs on Risk Assessment, CAPA, Quality by Design, and PAT
Conducted by Gamal Amer, Ph.D.

Sept 11    Risk Assessment and CAPA
Sept 25    Quality by Design
Oct 10      Process Analytical Technology (PAT)


 

Coming in
September 2008

 

Programs on Cleaning and Cleaning Validation in Pharmaceutical Facilities
Conducted by Bill Hall, Ph.D. - Worldwide Expert on Cleaning and Cleaning Validation in the Pharmaceutical Industry

Dr. Bill Hall is a consultant who has worked on cleaning programs in more than 300 companies worldwide. He has published more than 100 periodicals and textbooks and has taught FDA in the area of cleaning and cleaning validation. Dr. Hall has over five decades of total pharmaceutical experience including academic (teaching at University of North Carolina at Chapel Hill) and in R&D, Quality Assurance, Compliance, Stability, Validation, and QC Laboratories prior to becoming a consultant. He also serves as an Expert Witness for FDA in litigation activities.

He has been a past member of the PDA Task Force responsible for the preparation of the position paper on cleaning validation (Technical Bulletin # 29), as well as numerous academic groups such as the American Association of Colleges of Pharmacy.  He is listed in Who’s Who in Science, Who’s Who in America, and Personalities of the South.  He is also a member of the Dean's Advisory Council of the School of Pharmacy, University of Arkansas Medical Sciences.


 

Call us to register

714-289-1233

 

Starting December 8, 2008
Web course - Three 2.5 hour session

Fundamentals of HPLC
Conducted by Tom Jupille, LC Resources, Inc.
If you’re an auditor or reviewer, a manager, or a lab worker getting started in HPLC, you need this course! Benefits include:
*
Advance copies of course handout material sent to you as PDF files for you to print and annotate.
* Access to an exclusive private discussion board on Chromatography Forum so you can ask more extensive questions and get follow up information.
* On demand review available. Sessions are recorded; you can review them at any time during the following week.
 
Dec 8, 12, 19            11:00AM - 2:30 PM EST
$597 for first person from a company, $297 for each additional person from same company


 

Archived Web Seminars

All of our Web Seminars are recorded and available on CD along with the handout materials.  Click on Review to read the full description of the program.


HPLC seminars

   
 
  Method Development Strategies for Reversed-Phase HPLC
John W. Dolan, Ph.D.

 

  Use of Gradient Scouting Runs in HPLC Method Development
Tom Jupille

 

  Column Selection for HPLC Method Development
John W. Dolan, Ph.D.

 

  HPLC Column Technology
Tom Jupille

 

  HPLC Separation of Ionic Samples
John W. Dolan, Ph.D.

 

  Determining Robustness and System Suitability for HPLC Methods
Tom Jupille

 

  Principles of HPLC Troubleshooting
John W. Dolan, Ph.D.

 

  Troubleshooting HPLC Pumps and Autosamplers
John W. Dolan, Ph.D.

 

  Troubleshooting Physical Problems with HPLC Columns
Tom Jupille

 

  Troubleshooting Chemical Problems with HPLC Columns
Tom Jupille

 

  HPLC Detectors: Principles of Operation and Troubleshooting of Major HPLC Detectors
John W. Dolan, Ph.D.

 

  Problems with HPLC Quantification, Integration and Data Systems
John W. Dolan, Ph.D.

 

  Conducting Periodic HPLC Performance Checks: Keys to Reliable System Operation
John W. Dolan, Ph.D.

 

  How to Reduce Integration Errors in Chromatographic Analysis: When Peaks are of Approximately Equal Size
Conducted by Merlin K. L. Bicking, Ph.D.

 

  How to Reduce Integration Errors in Chromatographic Analysis: When Peaks are NOT the Same Size
Conducted by Merlin K. L. Bicking, Ph.D.

 

  Common Problems with Gradient Elution Liquid Chromatography: Proven Solutions and Prevention Strategies
Conducted by John W. Dolan, Ph.D.


  A Bestiary of "Exotic" HPLC Columns
Conducted by Tom Jupille


  HPLC Diagnostics: What to Do When Things Go Wrogn!
Conducted by Tom Jupille

GC seminars    


  Digging for the Truth in Gas Chromatography: Unlocking the Mystery Behind GC Inlets  Parts I and II
Joseph M. Levy, Ph.D.


  Digging for the Truth in Gas Chromatography: GC Peak Shape Troubleshooting  Parts I and II
Joseph M. Levy, Ph.D.

GMP seminars    

 

  Implementing FDA’s New Guidance: Quality Systems Approach to Pharmaceutical CGMP Regulations
New Recommendations to Facilitate Modernization of Drug Manufacturing
David Markovitz


  Implementing cGMPs for Dietary Supplements
David Markovitz

 

  A Case Study in Commissioning and Validation: Application of Commissioning and Validation
to a cGMP Project

Lou Angelucci

 

  Environmental Monitoring: The True Reasons
Gamal Amer, PhD


  The How-to Guide to Effective Cleaning and Cleaning Validation
Gamal Amer, PhD


  Effectively Implementing CAPA (Corrective and Preventive Action): A Risk Mitigating Quality System
Gamal Amer, PhD


  Master Planning for Validation: Doing it Right!
Conducted by Gamal Amer, PhD

 

  Validation Protocol Development and Acceptance Criteria
Conducted by Gamal Amer, PhD


  Validation Protocol Execution and Addressing Deviations
Conducted by Gamal Amer, PhD

 

  Validation and Change Control: The Validation Life Cycle
Conducted by Gamal Amer, PhD

 

  ASTM E2500 Consensus Standard: An Overview of a New Approach to Validation
Conducted by Gamal Amer, PhD


  Using Statistical Methods to Design Method Validation
Steven Walfish


  How Far is Too Far? Using Statistical Methods for Effective Outlier Detection
Steven Walfish


  Application of Design of Experiments (DOE) to Process Characterization
Steven Walfish


  Effective Data Presentation and Outlier Analysis
Conducted by Steven Walfish

 

  Avoiding Statistical Pitfalls during Method Validation
Conducted by Steven Walfish


  How to Manage Regulatory Inspections: Getting Ready: Pre-Inspection Auditing, Pre-Approval Inspection Preparation, and System-based Inspections
David Inglis, Ph.D.


  How to Manage the Inspection Room and the Control (War) Room during Regulatory Inspections
David Inglis, Ph.D.


  Staff Training and Preparation for a Regulatory Inspection
David Inglis, Ph.D.