Saturday, November 19, 2022

Reminder: Hi , learn how to avoid DATA INTEGRITY issues!

Live Webinar

Data Integrity


Key Considerations


November 29th, 2022

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Workshop Details


Time - 2:00 pm - 4:00 pm


Cost - CAD $350 + HST


Location - Online. Live. Interactive. Instructor Led


Abstract:

Data integrity is a key component in making informed decisions within any regulated organization. Reliable data promotes good decisions.


Unmanaged and inaccurate data will have consequences on a company’s quality output, state of compliance, the risk to patient safety, and ultimately, the bottom line.


This webinar focuses on principles of DI and how to manage DI issues and prevent recurrence. Ensure your data integrity program is compliant. Develop a strategy after getting the information you need in this live webinar.


Course Outline

  • What is Data Integrity and why is it important?
  • Regulatory Background
  • Types of Data Integrity
  • Key principles of Data Integrity and ALCOA+
  • Elements of Data Integrity
  • Leading causes of Data Integrity failures
  • Evaluating Data Integrity Compliance
  • How to comply with FDA Data Integrity requirements?
  • Data Integrity by Design
  • Data Integrity and automated systems
  • Data Integrity most common root causes and how they can be addressed?
  • FDA warning letters and 483s related to Data Integrity
  • Data Integrity and cGMP
  • Current Data Integrity trends in Pharmaceutical Industry
  • Case Studies


Who Should Attend

This webinar is intended for anyone involved with Quality Assurance in Pharmaceuticals, Food, or Cannabis.

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Friday, November 18, 2022

Need QAP Qualification? Register today and get certified!

QA for Cannabis Certificate



November 29, 2022 to December 02, 2022

Special Offer Ending Soon!

Register Now to Save on this Certificate Program

10 days left! Register NOW!

Greetings!


LIMITED TIME OFFER: CAD$3600 + HST (20% off of $4500)


The quality department is responsible for activities that have impact on the quality, safety or efficacy of cannabis products the company produces. They are also responsible for ensuring that all contracted services are verified to meet quality standards set by both the company and the regulator. In this training, attendees will gain understanding on concepts such as Good Production Practices (GPP), quality system requirements including Standard Operating Procedures (SOPs), complaints, recalls, laboratory testing and sanitation programs.


Attendees will be given ample opportunity to ask questions and to learn about the vast responsibility of the Quality Assurance Person (QAP) role.


Course Outline

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Meet Your Instructors

Vasiliki Koutsandrea

Jason Chu

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Thursday, November 17, 2022

Hi , how to classify and report ADEs? Find out today!

Drug Safety and Adverse Drug Reaction Reporting Workshop


December 02, 2022

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Workshop Details


Time - 9:00 am - 5:00 pm


Cost - CAD $645 + HST


Location - Online. Live. Interactive. Instructor Led


Abstract:

This workshop will explain the importance of adverse drug reactions, the Canadian MedEffect Scheme, the source of adverse drug reaction reports and the differences between serious and non-serious events. In addition, a MedEffect form will be completed in class.


Course Outline

On completion of this workshop students should be able to:

  • explain the importance of adverse drug reaction reporting
  • explain the importance of the Canadian MedEffect system
  • understand the source of safety reports
  • explain how the safety reporting Scheme works
  • differentiate between serious and non-serious ADRs and identify when completion and submission of MedEffect forms is required
  • complete a MedEffect form

 

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.
Get Certified!
LEARN MORE ABOUT THE WORKSHOP IN DETAIL

Follow us on Social Media to get regular news and updates!

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