Instructor :
John Fetzer

Webinar ID:
6906

Did you know that as per a report by the U.S. FDA, one of the major reasons for pharmaceutical recalls and laboratory mishaps is improper or inadequate validation of analytical methods?

In fact, the lack of GLP (Good Laboratory Practices) compliance results in over 50% of all non-compliances recorded, directly affecting product quality, and ultimately the company’s reputation.

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Adhering to GLP guidelines is not only crucial for maintaining the integrity of your laboratory operations but also for meeting regulatory requirements.

This training will provide you with in-depth insights into GLP principles and equip you with the tools to achieve compliance with international regulatory bodies, such as the FDA, EMA, and more.

This webinar will discuss the best practices of analytical method validation, including

• Components of a validation
• How to include critical reagents comparison
• Selectivity experiments
• Assessment of stability
• Importance of communication between the development and the validation labs
• Accuracy of transfer documents (SOPs).

Participants will understand:

1. Is validation a regulated activity?
2. When to pull the trigger for validation?
3. What is the Importance of suitability testing?

Join Now!

Did you know that as per a report by the U.S. FDA, one of the major reasons for pharmaceutical recalls and laboratory mishaps is improper or inadequate validation of analytical methods?

In fact, the lack of GLP (Good Laboratory Practices) compliance results in over 50% of all non-compliances recorded, directly affecting product quality, and ultimately the company’s reputation.

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Adhering to GLP guidelines is not only crucial for maintaining the integrity of your laboratory operations but also for meeting regulatory requirements.

This training will provide you with in-depth insights into GLP principles and equip you with the tools to achieve compliance with international regulatory bodies, such as the FDA, EMA, and more.

This webinar will discuss the best practices of analytical method validation, including

• Components of a validation
• How to include critical reagents comparison
• Selectivity experiments
• Assessment of stability
• Importance of communication between the development and the validation labs
• Accuracy of transfer documents (SOPs).

Participants will understand:

1. Is validation a regulated activity?
2. When to pull the trigger for validation?
3. What is the Importance of suitability testing?

Join Now!

In an age where accurate, timely, and reliable laboratory results are crucial, validation of analytical methods under Good Laboratory Practices (GLP) is not just a recommendation – it’s an imperative. The FDA estimates that 80% of all product recalls can be tied to a failure in validation!

Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees validity of results.

If you work in pharmaceuticals, chemicals and petrochemicals, and environmental analyses then you are mandated to be following GLP. One of the major tasks in GLP is validation of an analytical method.

The new pharmaceuticals are very often completely new compounds, structures never studied before by chemists. Their properties – such as solubilities and acid-base nature, are unknown.

Synthetic reactions may make many similar types of molecules, including structural and optical isomers.

The methodologies that mean US Food and Drug Administration compliance with GLP require a separation to be able to separate and identify all major, minor, and trace components.

It is no longer just determining a purity of the main component. Each minor contaminant or degradation product is also important in GLP.

This analytical method validation webinar will provide practical tips on how to validate an analytical method under the GLP requirements.

It is recommended for laboratories that are under, or want to be under, Good Laboratory Practices (GLP).

Enroll Now!

In an age where accurate, timely, and reliable laboratory results are crucial, validation of analytical methods under Good Laboratory Practices (GLP) is not just a recommendation – it’s an imperative. The FDA estimates that 80% of all product recalls can be tied to a failure in validation!

Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees validity of results.

If you work in pharmaceuticals, chemicals and petrochemicals, and environmental analyses then you are mandated to be following GLP. One of the major tasks in GLP is validation of an analytical method.

The new pharmaceuticals are very often completely new compounds, structures never studied before by chemists. Their properties – such as solubilities and acid-base nature, are unknown.

Synthetic reactions may make many similar types of molecules, including structural and optical isomers.

The methodologies that mean US Food and Drug Administration compliance with GLP require a separation to be able to separate and identify all major, minor, and trace components.

It is no longer just determining a purity of the main component. Each minor contaminant or degradation product is also important in GLP.

This analytical method validation webinar will provide practical tips on how to validate an analytical method under the GLP requirements.

It is recommended for laboratories that are under, or want to be under, Good Laboratory Practices (GLP).

Enroll Now!

• Is Validation A Regulated Activity
• Method Validation
• When to Pull The Trigger for Validation
• The Criteria For A Method
• Statistical Requirements
• Importance of Suitability Testing
• Selectivity Experiments
• Assessment of Stability
• Accuracy of Transfer Documents (SOPs)
• Communication Between The Development and The Validation Labs
• Maintaining Compliance

BONUS:

1. PDF copy of the presentation handout for your future reference.
2. Soft copy of the certificate of completion on request.
3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

• Is Validation A Regulated Activity
• Method Validation
• When to Pull The Trigger for Validation
• The Criteria For A Method
• Statistical Requirements
• Importance of Suitability Testing
• Selectivity Experiments
• Assessment of Stability
• Accuracy of Transfer Documents (SOPs)
• Communication Between The Development and The Validation Labs
• Maintaining Compliance

BONUS:

1. PDF copy of the presentation handout for your future reference.
2. Soft copy of the certificate of completion on request.
3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Maximize The Learning Experience in A Group Setting!

• Laboratory Managers/Supervisors
• Quality Assurance Managers
• Analytical Chemists
• Research Scientists
• Validation Specialists
• Regulatory Affairs Managers
• Quality Control Managers
• Compliance Officers
• Data Integrity Officers
• Quality Assurance/QC Analysts

Maximize The Learning Experience in A Group Setting!

• Laboratory Managers/Supervisors
• Quality Assurance Managers
• Analytical Chemists
• Research Scientists
• Validation Specialists
• Regulatory Affairs Managers
• Quality Control Managers
• Compliance Officers
• Data Integrity Officers
• Quality Assurance/QC Analysts