Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

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

Best practices and strategic approach for evaluating computer systems

  • 15-October-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

Aseptic Processing Overview and Validation

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

Requirements for aseptic and bulk manufacturing operations

  • 15-October-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 180 Minutes

USDA Final Genetically Modified Organism (GMO) Label Rule

By: Dr. John M. Ryan ,Quality assurance administrator.

Food manufacturers are required to “prominently’ display clear label information

  • 16-October-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

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

Latest trends in human error issues in the industry

  • 17-October-2019| 03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 90 Minutes

21st Century Cures Act -New Guidance on Medical Device Software Compliance

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

Waive the requirement for “informed consent” in specific cases

  • 17-October-2019| 11:00 AM ET | 08:00 AM PT | 10:00 AM CT Duration 90 Minutes

Regulatory Requirements for Registration of Medical Device Products in China

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

Learn how to prepare the necessary documents and register your product with the Chinese regulatory authorities

  • 17-October-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

The Value of Human Factors

By: Thomas Bento ,Sr. Regulatory Consultant.

The ISO 62366 is noted by FDA as a “Consensus” Standard, making it a gold standard

  • 22-October-2019| 11:00 AM ET | 08:00 AM PT | 10:00 AM CT Duration 60 Minutes

Step-by-Step Process for Successful Sterility Failure Investigations

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

When a sterility test failure occurs

  • 22-October-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Statistical Process Control – Keys to Assess Process Variation and Ensure Quality

By: William Levinson ,Principal Consultant at Levinson Productivity.

Understand the basics of SPC, as well as the effect of variation on quality and the difference

  • 23-October-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Preparing for and responding effectively and in a positive manner to an FDA postmarked surveillance visit

By: Dr. George Yanulis ,Medical Device R&D Engineer.

Understand the nature, severity, or frequency of suspected problems reported in adverse

  • 23-October-2019| 03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 90 Minutes

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

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

Electronic Records & Electronic Signatures

  • 29-October-2019| 1:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 240 Minutes

Your Social Media Marketing is Under FDA's Microscope

By: Casper (Cap) Uldriks ,Founder Encore Insight LLC.

The use of social media is ripe for regulatory blunders if your not paying attention.

  • 30-October-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Emerging Issues in Food Safety, Locally. Nationally and Globally

By: Michael Brodsky ,Lead Auditor, Canadian Association for Laboratory Accreditatio.

Complexity of providing safe food and examine the factors that impact on microbiological food safety

  • 31-October-2019| 01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 60 Minutes

Medical Device Recalls: How to Properly, Compliantly, and Promptly Deal with a Recall

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

Protects your firm from more severe action by the FDA

  • 05-November-2019| 12:00 PM ET | 9:00 AM PT | 11:00 AM CT Duration 180 Minutes

Medical device cybersecurity following latest FDA Guidance in 2019

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

A program that will be compliant to the FDA requirements

  • 06-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Handling OOS Test Results and Completing Robust Investigations

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Detection an out-of-specification result to informal and formal laboratory and batch investigations

  • 07-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS

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

General public assumes manufactured pharmaceutical products are safe

  • 12-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Analytical Method Validation

By: John G. Lanese ,President at The Lanese Group, Inc.

Best practices of analytical method validation

  • 12-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Navigating the 510(k) process

By: Thomas Bento ,Sr. Regulatory Consultant.

Simplified defensible approach to a successful submission

  • 12-November-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 60 Minutes

APPLYING COMPUTER SYSTEM VALIDATION TO MOBILE APPLICATIONS

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

Computer system validation can be applied to mobile applications

  • 12-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Developing premarket approval packages for innovations which are more effective in reducing potential adverse events; MAUDES; and or recalls particularly FDA class recalls

By: Dr. George Yanulis ,Medical Device R&D Engineer.

Premarket Approvals Premarket approval (PMA) are required by The Food and Drug

  • 13-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

FDA’s New Import Program for 2019: Be Prepared and Be Compliant

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

Failure to provide the correct information creates costly delays

  • 13-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Risk Management of Source Water used in the Food Industry

By: Michael Brodsky ,Lead Auditor, Canadian Association for Laboratory Accreditatio.

The limitations of how potability is currently defined and examine options for mitigating

  • 13-November-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 60 Minutes

3-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2019

By: Casper (Cap) Uldriks ,Founder Encore Insight LLC.

What happens when your product is detained?

  • 14-November-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 180 Minutes

European Medical Device Regulations (EU MDR): Strategic Planning for the Coming Critical Changes

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Device makers face a market upheaval in the EU. A new set of rules

  • 19-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Corrective and Preventive Action; Your Most Important Process

By: William Levinson ,Principal Consultant at Levinson Productivity.

CAPA is arguably the most important process in a quality management system

  • 20-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Post-Market Activities in the EU-MDR — A Detailed Analysis(Part 1,21-Nov-19 & Part 2,22-Nov-19

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

What are the key elements of a PMS system?

  • 21-November-2019| 02:30 PM ET | 11:30 AM PT | 01:30 PM CT Duration 180 Minutes

Understanding and Implementing a Technology Transfer Process

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

Identify New Product transfer process

  • 02-December-2019| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

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

  • 03-December-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

3-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance

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

Current trends in cybersecurity threats to medical devices

  • 04-December-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

FDA Regulations for Analytical Instrument Qualification and Validation Processes

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

Global agencies expectations of analytical equipment qualification along with the development

  • 05-December-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Assess Your Laboratory - Based on the FDA System Based Inspection

By: John G. Lanese ,President at The Lanese Group, Inc.

Quality Control Laboratory plays an important part role

  • 05-December-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

4-Hour Virtual Seminar on FDA and U.S. Customs Import Rules and Export Traps in 2020

By: Casper (Cap) Uldriks ,Founder Encore Insight LLC.

A failure to do things correctly will create a "bad actor" image

  • 10-December-2019| 11:00 AM ET | 08:00 AM PT | 10:00 AM CT Duration 240 Minutes

The Validation of Non Product Software

By: Thomas Bento ,Sr. Regulatory Consultant.

How to comply with 21 CFR Part 820.70(i) and effectively implement a software validation

  • 10-December-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Live Webinar Pharmaceutical Quality Risk Management (QRM) Overview

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

Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system.

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

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
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