Tuesday, June 6, 2023

Take advantage of this opportunity to boost your proficiency in Drug Safety and Pharmacovigilance

Greetings!


The Workshop includes the historical overview of drug safety legislation, from the beginning to the current international standards; basic definitions and tools of adverse events and adverse drug reactions recording, assessment and reporting, as well as pharmacological mechanics of drug safety. 

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Course Outline


The following specific topics will be addressed in detail:



  • Drug Safety and Pharmacovigilance: The Basics and History
  • Terminology, Definitions
  • Adverse drug reactions: severity and seriousness grading, causality assessment, and reporting
  • International standards of drug safety surveillance (ICH guidelines and US standards).
  • Drug safety reports: Individual Case Safety Reports and Expedited Reporting


Who Should Attend


Professionals working in the area of:


  • Clinical safety & pharmacovigilance
  • Clinical research
  • Regulatory affairs
  • Medical writing
  • Marketing


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Date and Time:

June 22, 2023

9:00 AM - 5:00 PM (EST)


How is the webinar delivered?

Online, Live, Interactive, Instructor-led

GET CERTIFIED TODAY!

Interested in this workshop?

Register today by calling our team at 416-502-2277 or email us at info@aaps.ca.

Academy of Applied Pharmaceutical Sciences

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Master the Art of CAPA Strategy with our Workshop! Register Today!

Greetings!


A key role for Quality Assurance professionals is identifying and addressing deviations from standard operating procedures and regulatory requirements. In order to effectively prevent recurrence of the events, it is very important to correctly identify and address the underlying root causes.


This not only involves dealing with specific incidents but also taking a holistic view of the process to ensure that it is fundamentally sound and is designed in such a way as to minimize the occurrences of deviations.

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The following topics will be covered during the Workshop:


  • Introduction to Lean
  • Essentials for Good Processes (5 Principles of Lean)
  • Identifying Non-Value Added Activities (8 Wastes of Lean)
  • Lean Problem Solving Methodology
  • Effective Problem Definition
  • Root Cause Identification
  • Process Mapping
  • Corrective Action Development
  • Confirmation of Results
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Date and Time:

June 30th, 2023

2:00 PM - 4:00 PM (EST)


How is the workshop delivered?

OnlineLive, Interactive, Instructor-led

Get Certified Today

Interested in this workshop?

Register today by calling our team at 416-502-2277 or email us at info@aaps.ca.

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Monday, June 5, 2023

Seize this chance to enhance your expertise in Drug Safety and Pharmacovigilance.

Greetings!


The Workshop includes the historical overview of drug safety legislation, from the beginning to the current international standards; basic definitions and tools of adverse events and adverse drug reactions recording, assessment and reporting, as well as pharmacological mechanics of drug safety. 

LEARN MORE

Course Outline


The following specific topics will be addressed in detail:



  • Drug Safety and Pharmacovigilance: The Basics and History
  • Terminology, Definitions
  • Adverse drug reactions: severity and seriousness grading, causality assessment, and reporting
  • International standards of drug safety surveillance (ICH guidelines and US standards).
  • Drug safety reports: Individual Case Safety Reports and Expedited Reporting


Who Should Attend


Professionals working in the area of:


  • Clinical safety & pharmacovigilance
  • Clinical research
  • Regulatory affairs
  • Medical writing
  • Marketing


LEARN MORE

Date and Time:

June 22, 2023

9:00 AM - 5:00 PM (EST)


How is the webinar delivered?

Online, Live, Interactive, Instructor-led

GET CERTIFIED TODAY!

Interested in this workshop?

Register today by calling our team at 416-502-2277 or email us at info@aaps.ca.

Academy of Applied Pharmaceutical Sciences

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How to set up GMP compliant temperature mapping? Learn more today

Greetings!


GMP Temperature Mapping should be done on a periodic basis, in order to demonstrate continuing compliance. Temperature Mapping should also be done when significant changes have been made to the equipment and storage areas which could impact air circulation or loading or unexplainable variability in temperature occurs outside of the specifications.

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Course Outline


The following specific is the agenda for the workshop



  • Definition
  • Temperature Mapping Introduction
  • Why should you comply?
  • What is a Quality Product?
  • How do we achieve Compliance?
  • Environmental Controls
  • Application of Controls
  • Selection of data loggers
  • When should temperature mapping be completed?
  • Audit and Risk Assessment
  • Temperature Mapping Protocol
  • Methodology
  • Review and Data Analysis
  • Summary Report
  • Impact of not completing Temperature Mapping
  • Final Advice
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Date and Time:

June 15th, 2023

1:00 PM - 4:00 PM (EST)


How is the webinar delivered?

OnlineLive, interactive, instructor-led

GET CERTIFIED TODAY!

Interested in this workshop?

Register today by calling our team at 416-502-2277 or email us at info@aaps.ca.

Academy of Applied Pharmaceutical Sciences

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