Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Audit Trail Generation and Review

Computerized systems are used throughout the life sciences industry to support various regulated activities,which in turn generate many types of electronic records.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

Computer System Validation (CSV) for FDA-Regulated Computers

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

2-Hour Virtual Seminar on Laboratory Investigation of Out-of-Specification Results

In this webinar we will review what happened in the industry that drove the FDA to pay close attention to laboratory operations in general, and, specifically, the investigation of out-of-specification (OOS) test results.

Speaker: Jerry Lanese | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Audit Trail Generation and Review

This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details