3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11

Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance.

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details

Data Integrity and Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry.

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

Analytical Method Validation Under Good Laboratory Practices - GLPs

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.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications.

Speaker: Steven Wachs | View Anytime | Duration: 90 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

FDA Compliance for Mobile Applications

Attend this webinar to understand the FDA guidance for mobile applications.

Speaker: Eleonora Babayants | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

Analytical Method Validation Under Good Laboratory Practices - GLPs

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.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Dietary Supplements CGMPS - 21 CFR 111 Compliance

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

GMP Expectations for Products Used in Early Phase IND Studies

FDA issued a guidance document covering GMP requirements for Phase 1 products.

Speaker: Steven S. Kuwahara | 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

FDA's Cloud Compliance & Regulations

This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

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

The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization

Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS).

Speaker: Eyal Lerner | View Anytime | Duration: 90 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

Good Documentation Practices to Support FDA Computer System Validation

As a "GxP"system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.

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

3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science".

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.

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.

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

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