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 90 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

Your Social Media Marketing is Under FDA's Microscope

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

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

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

10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love

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

Understanding of the regulatory expectations for Data Integrity

  • 03-December-2019| 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

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

Risk of Objectionable Microorganisms in Bio-Pharmaceutical Manufacturing

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

Objectionable microorganisms

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

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

  • 05-December-2019| 03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 60 Minutes

How to Manage Your Vendors in Clinical Research

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Current FDA regulations and ICH guidelines

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

Complaint Handling – Best Practices: What Life Sciences Companies Need to Know Now

By: Peggy J. Berry, MBA, RAC ,President & CEO at Synergy Consulting.

Effective internal systems for receiving

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

Good Documentation Practice (GDocP) for FDA Regulated Industries

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Connection between GxP/GMP and document control

  • 23-January-2020| 10:30 AM ET | 07:30 AM PT | 09:30 PM CT Duration 60 Minutes

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

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

Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor

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

GDPR Compliance

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Create better data protection policies and to hold the organizations

  • 04-February-2020| 10:30 AM ET | 07:30 AM PT | 09:30 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

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

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
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