Monday, January 30, 2023

Want to get your Medical Device approved? Learn the latest regulations here!

Medical Devices Regulation in Canada

– Principles and Recent Updates Workshop

Medical devices companies who develop their products and

wish to sell them in the Canadian market, must acquire knowledge of the Canadian regulatory requirements for medical devices.

Moreover, in order to be able to commercialize their products, the manufacturer/importer/distributer must be aware of the new regulatory framework that Health Canada has developed for these products.

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Course Outline

Introduction
Canadian regulations of medical devices
Comparison of regulatory requirements in Canadian and other jurisdictions (US, EU)
Mutual recognition of data between various regulatory authorities
Preparation and submission of Pre-ITA, ITA, Licensing application

Quality systems according to ISO 13485:2016
GMP
Risk management according to ISO 14791
Clinical trials
Vigilance program
Preparation for audits in compliance with Health Canada requirements
New Canadian regulatory requirements

How is the workshop delivered?

Live, interactive, instructor-led

Date and Time:

February 22, 2023

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

Academy of Applied Pharmaceutical Sciences

Thursday, January 26, 2023

State of Pharma Conference: Save the DATE!

The State of Pharma (SOP) conference will provide a premier interdisciplinary platform for researchers, practitioners, and representatives from governing bodies to present and discuss the most recent innovations, trends, concerns and practical challenges impacting the pharmaceutical industry at this very moment.

From decision-making regulators actively shaping the future of the industry, to business leaders at the forefront of innovation - this is the most crucial platform for those looking to navigate, and learn directly from industry leaders.

Secure your seat today to avoid missing out and stay tuned for our next announcement to get updates on the full lineup of speakers and agenda!

The final agenda for The State of Pharma has been released and we're excited to be bringing you a day-long program containing in-depth discussions on a wide range of topics related to the pharmaceutical industry.

On May 11th, we will address current challenges and potential solutions within the industry and touch upon the areas of regulation, innovation, and much, much more.

View the full agenda today.

Amanda McFarland specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and a member of the Kilmer Regulatory Innovation team.

We are inviting a limited number of organizations to join as Sponsors of the event. For more information or to express an interest please reach out to info@aaps.ca.

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Wednesday, January 25, 2023

All you need to know about DATA INTEGRITY!

Data Integrity: What Regulators Are Looking For?

February 23rd, 2023

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.

Get Certified!

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Monday, January 23, 2023

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

Developing an Effective CAPA Strategy

Date/Time : February 25, 2023 | 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: