Tools for Human Error Reduction

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

Tools for measurement and Key Performance Indicators

  • 25-February-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Pharmaceutical and Medical Device Regulations in 2020: FDA Priorities in the Upcoming Election Year

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

The FDA will continue to grapple with its major 2019 issues in 2020

  • 26-February-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Important Changes in the Latest IVDR for Software

By: Nancy Knettell ,Founder and Principal at Software510, LLC.

This course will ensure that IVD Diagnostic companies that depend on custom software to deliver

  • 27-February-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

GDPR Compliance

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Create better data protection policies and to hold the organizations

  • 28-February-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Incoterms® 2020 Rules

By: Jan Seal ,International Trade Consultant.

Latest developments in commercial practice

  • 03-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Understanding the Drug Supply Chain Security Act: Latest Regulatory Developments and Best Practices

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

The implementation processes in order to gain a clear understanding of the guidelines

  • 04-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Understanding and Implementing a Quality by Design Program

By: Steven Laurenz ,Principal Consultant, Biophia Consulting Inc.

The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised.

  • 05-March-2020| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Vendor selection is a serious process. Manufacturers are responsible for compliance with their selected vendors

By: Joy McElroy ,Principle Consultant, Maynard Consulting Company.

what qualifies a foreign vendor and what disqualifies a foreign vendor

  • 12-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

Developing a Strategic Approach to FDA Compliance for Computer Systems

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC)

  • 12-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Process Monitoring, Control and Improvement

By: Ron Snee ,Founder and President of Snee Associates.

Concepts, methods and tools used in process monitoring, control and improvement

  • 17-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Good Manufacturing Practices Training | GMP Course

By: Todd Graham ,Managing Partner, Delevan Street Biosciences.

We will review how all of this work should be documented

  • 18-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Knock, knock, who’s there? Are you ready for an FDA inspection?

By: Susanne Manz, MBA, MBB, RAC, CQA ,Quality and Compliance Expert / Auditor for Medical Devices.

This webinar can help you prepare a strategy and detailed plans to more successfully prepare

  • 19-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Data - Governance, Risk, Compliance

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Documentation is a critical tool for ensuring GxP/GMP compliance

  • 24-March-2020| 10:30 AM ET | 07:30 AM PT | 09:30 PM CT Duration 90 Minutes

Medical Device Changes, the 510(k) and FDA's Two Guidance Documents on Device and/or Software Changes

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

The FDA expects companies to perform meaningful, results driven 510(k)

  • 24-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

EU Medical Device Regulation (MDR 2017/745): Latest Update and Approaching Deadline

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

Plan an efficient transition and understand the most critical lessons to prepare for this transition

  • 25-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

How to write SOP's that Avoid Human Error

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

Development to formats designed for human error reduction

  • 26-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

By: Joy McElroy ,Principle Consultant, Maynard Consulting Company.

How to apply consistent Meta tags and policies to all documents and records

  • 07-April-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

FDA’s Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act

  • 09-April-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

HIPAA Audits and Enforcement for 2020 – New Penalties, New Guidance for Business Associates, New Focus on Access

By: Jim Sheldon-Dean ,Founder and director of compliance services at Lewis Creek Systems, LLC.

Enforcement actions taken by HHS and state Attorneys General to illustrate

  • 14-April-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Fishbone Diagramming: Learn How to Improve Your Business and Bottom Line

By: Dr. Michael Abitz ,Adjunct Professor, Colorado Technical University.

Webinar will help process owners eliminate process variation

  • 15-April-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Successful 510(k) Documentation for Software or Software Containing Medical Devices

By: Nancy Knettell ,Founder and Principal at Software510, LLC.

This training will also show you how to prevent serious Post Market audit

  • 21-April-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Managing The Audit Function In A Global Company

By: José Mora ,Principal Consultant.

Avoid group-think and to also properly assess and advise senior management.

  • 28-April-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Exporting to Mexico Procedures and Documentation

By: Jan Seal ,International Trade Consultant.

Preventing errors that could result in severe civil and/or criminal penalties

  • 28-April-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) vs GMPs – Comparison and Contrasts

By: Joy McElroy ,Principle Consultant, Maynard Consulting Company.

Good laboratory practices (GLPs) and good manufacturing practices (GMPs)

  • 07-May-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 240 Minutes

Accelerating Formulation Development – Getting the Right Data in the Right Amount at the Right Time

By: Ron Snee ,Founder and President of Snee Associates.

What Strategies Should I Use to Speed Up Formulation Development?

  • 13-May-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning

  • 19-May-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Design Controls for Quality and Compliance

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Design Control is not only a regulatory requirement, it is a set of aligned practices

  • 21-May-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Medical Device Software: Verification, Validation & Compliance

By: Nancy Knettell ,Founder and Principal at Software510, LLC.

This webinar will ensure that device companies will know exactly what documentation needs

  • 04-June-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Understand in detail Computer System Validation (CSV)

  • 07-July-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

FDA Compliance and Mobile Applications

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

for planning, executing or managing the implementation of any system governed by FDA regulations

  • 10-September-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
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