GMP and cGMP Web Seminars

We have conducted over 500 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.

View our Archived Web Seminars below the upcoming Web Seminars.


 

GMP Training in Tough Times - Getting it Right!

Developing and Deploying a Successful GMP Training Program
Secrets of a Master Trainer Revealed

Conducted by David Markovitz

March 12         Learn More



Proven Steps to Reducing Waste in Process Validation

Conducted by Gamal Amer, Ph.D.

March 19         Learn More


 

Defining Risk and Risk Levels
Implementing ICH Q9 - Quality Risk Management

Conducted by Gamal Amer, Ph.D.

April 9         Learn More


Implementing cGMPS for Dietary Supplements

Conducted by David Markovitz

April 16        Learn More



How to Implement FDA's New Guidance on Process Validation

Conducted by Gamal Amer, Ph.D.

April 23         Learn More


Validation Protocol Development and Acceptance Criteria

Conducted by Gamal Amer, Ph.D.

May 7          Learn More


Validation Master Planning: Doing it Right!

Conducted by Gamal Amer, Ph.D.

May 14         Learn More


Validation of Heating, Ventilation, and Air Conditioning Systems in the Biopharmaceutical Industry

Conducted by Gamal Amer, Ph.D.

May 21         Learn More


 

ASTM E2500 Consensus Standard: An Overview of a New Approach to Validation

Conducted by Gamal Amer, Ph.D.

June 11         Learn More



Archived Web Seminars

All of our Web Seminars are recorded and available on CD or MP3 file 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
Merlin K. L. Bicking, Ph.D.


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


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


A Bestiary of "Exotic" HPLC Columns
Tom Jupille


HPLC Diagnostics: What to Do When Things Go Wrong!
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

Making GMP a Lifestyle in Your Company,
and Not Just a Regulation

Conducted by David Markovitz

Developing and Deploying a Successful GMP Training System
Secrets of a Master Trainer Revealed
David Markovitz

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

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Review 
New Revisions to Drug cGMP: What You Must Do to Comply
David Markovitz
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Review 
Managing Your Career in a Down Economy: How to Save Your Job and Survive a Corporate Downsizing
Special audio seminar conducted by David Markovitz


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


Validation Evolution: Are We Abandoning IQ and OQ?
How to Comply with FDA's New Changes for Process Validation
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!
Gamal Amer, PhD


Validation Protocol Development and Acceptance Criteria
Gamal Amer, PhD


Validation Protocol Execution and Addressing Deviations
Gamal Amer, PhD


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


How to Implement FDA's New Guidance on Process Validation
Gamal Amer, Ph.D.


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


Implementing a Risk-based Approach to GMP Compliance
Gamal Amer, PhD


FDA Inspections: What to Expect
Learning from Other People's Experiences

Gamal Amer, PhD


FDA Inspections: How to Prepare
Learning from Other People's Experiences

Gamal Amer, PhD


Outsourcing in the Healthcare Industry
How to Avoid the Perils and Pitfalls

Gamal Amer, Ph.D.


Defining Risk and Risk Levels
Implementing ICH Q9 - Quality Risk Management

Gamal Amer, Ph.D.


Fundamentals of Quality by Design (QbD)
Implementing ICH Q8 - Quality by Design

Gamal Amer, Ph.D.


Engineering Quality by Design (QbD)

Gamal Amer, Ph.D.


GMP, Validation, and Change Control:
Optimizing Key Elements of an Effective Compliance Program

Gamal Amer, Ph.D.


How to Conduct a Successful Supplier Audit: Protecting Your Supply Chain

Gamal Amer, Ph.D.


How to Investigate Deviations and Failures Effectively

Gamal Amer, Ph.D.


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
Steven Walfish


Avoiding Statistical Pitfalls during Method Validation
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.


Developing an Effective Response to Regulatory Inspections (FDA and EU)
David Inglis, Ph.D.



Effective GMP Auditing: Skills to Audit Manufacturing,
Laboratories, and Suppliers PART ONE

David Inglis, Ph.D.


Effective GMP Auditing: Skills to Audit Manufacturing,
Laboratories, and Suppliers PART TWO

David Inglis, Ph.D.


How to Effectively Manage Out of Specification (OOS) Results for Pharmaceutical Manufacturers
Laboratory Investigations

David Inglis, Ph.D.


How to Effectively Manage Out of Specification (OOS) Results for Pharmaceutical Manufacturers
Full Scale Extended Investigations

David Inglis, Ph.D.


Practical and Effective Application of Design Review:
An FDA Requirement for New or Modified Facilities or Systems

Miguel Montalvo