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

Data Integrity Practices for the Laboratory and Beyond

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

Data integrity governance program and principles for defining quality

  • 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

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

IT Systems Validation for FDA Regulated Industries

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

We will walk through the entire System Development Life Cycle (SDLC) approach to validation

  • 22-April-2020| 10:30 AM ET | 07:30 AM PT | 09:30 AM CT Duration 90 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

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

By: Roger Cowan ,Pharmaceutical Consultant, R Cowan Consulting Services LLC.

How environmental monitoring data is reviewed

  • 28-April-2020| 11:30 AM ET | 08:30 AM PT | 10:30 AM CT Duration 60 Minutes

Leadership Skills in a GMP Laboratory

By: Rob MacCuspie ,Scientist and business leader, MacCuspie Innovations.

Why invest time in developing leadership skills?

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