Tuesday, September 20, 2022

What is Pharmaceutical Temperature Mapping?

GMP Compliant and Temperature Mapping Workshop

Greetings!

GMP Temperature Mapping should be completed on a periodic basis, in order to demonstrate continuing compliance. Temperature Mapping should also be completed 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.

Temperature mapping is not only a regulatory requirement for your rooms or equipment. It is also a source of data you could rely on when it will be time to install your real time monitoring system. And help you to better understand how your products could be impacted by temperature deviations and take then appropriate decisions.

Course Outline

This webinar will cover the different best practices you have to implement, whether you ship or store temperature-sensitive products. Participants will learn about the regulator context, what has to be done and how with concrete real examples and case studies.

The course details will include:

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

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Date and Time:

September 29, 2022

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

How is the webinar delivered?

Live, interactive, instructor-led

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Interested in this workshop?

Academy of Applied Pharmaceutical Sciences

Thursday, September 8, 2022

Hi , do you know how to report Adverse Reactions with Health Canada?

Drug Safety and Adverse Drug Reaction Reporting Workshop

September 19, 2022

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.

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LEARN MORE ABOUT THE WORKSHOP IN DETAIL

Wednesday, September 7, 2022

What is Corrective and Preventative Actions (CAPA) and how to implement it?

Live Webinar Lean for Root Cause Analysis and Corrective Action

Date & Time: September 13, 2022 | 2:00PM - 4:00PM

Cost : CAD $515 + HST

Location : Online. Live. Interactive. Instructor Led

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.

This webinar will leverage Lean principles to get beyond the common root cause identification of “human error”. The tools and techniques presented in this course can be applied to everyday work to make processes simpler and reduce the time and effort required to complete daily tasks.

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Course Outline

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

Who Should Attend

This one-day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

Quality Assurance
Regulatory Affairs
Operations
Training & Development
Documentation and Technical Writing
Project Management

Schedule

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Academy of Applied Pharmaceutical Sciences

Tuesday, September 6, 2022

Hi , Want to work in QA for the Cannabis Industry?

QA for Cannabis Certificate

October 4-7, 2022

Special Offer Ending Soon!

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.