Workshop Details

Dates

June 20, 2024

Time

2:00 pm – 4:00 pm

Cost

CAD $600.00 + HST

Location

Online

Deadline

June 13, 2024

Workshop Overview

Quality Assurance professionals play a pivotal role in ensuring compliance with standard operating procedures and regulatory requirements. However, merely addressing deviations is insufficient without a robust strategy to prevent their recurrence. Identifying and addressing the underlying root causes is paramount to establishing a resilient quality management system. This workshop goes beyond surface-level analysis and embraces a holistic approach to process improvement.

By leveraging Lean principles, participants will explore innovative methods for root cause identification that transcend conventional attributions such as “human error.” The tools and techniques presented in this workshop empower attendees to streamline processes and minimize deviations, ultimately enhancing operational efficiency and regulatory compliance.

Join us to gain actionable insights that can be immediately applied to your daily work, simplifying processes and reducing the time and effort required to complete tasks. Elevate your CAPA strategy and drive continuous improvement within your organization.

Who Should Attend​

This workshop is tailored for Quality Assurance professionals, internal auditors, and individuals involved in regulatory compliance across various industries. It is also beneficial for those seeking to deepen their understanding of CAPA principles and best practices, especially within pharmaceutical, biotechnology, and medical device sectors.

Workshop Outline

This workshop covers the following topics:

  • Introduction to Lean Principles
  • Essentials for Good Processes
  • Identifying Non-Value Added Activities
  • Lean Problem-Solving Methodology
  • Effective Problem Definition
  • Root Cause Identification
  • Process Mapping
  • Corrective Action Development
  • Confirmation of Results

Learning Outcomes

Understanding Lean Principles:

Explore how Lean principles, such as waste reduction and continuous improvement, are applicable to CAPA processes, enhancing efficiency and effectiveness.

Problem Definition and Root Cause Identification:

Develop essential skills in articulating and defining problems within CAPA processes, alongside proficiency in identifying underlying root causes, fostering targeted and efficient problem-solving.

Lean Problem-Solving Mastery:

Acquire expertise in Lean problem-solving methodologies, enabling systematic approaches to address deviations within CAPA processes, driving continuous improvement and quality enhancement.

Corrective Action Application and Verification:

Apply Lean principles to develop robust corrective actions aimed at addressing identified root causes, ensuring effectiveness through verification and ongoing monitoring of results within CAPA workflows.

All participants will receive a certificate of attendance upon completion of the workshop.

Note: Registration closes one week prior to the start of workshop.

Developing an Effective CAPA Strategy

June 20, 2024

Other Workshops Available

Rany Attalla

AAPS

Instructor

Mr. Rany Attalla has over twenty years of Pharmaceutical business, Sales, production and Quality Assurance experience in Canada and other parts of the world.

Rany has a strong understanding of regulations that pertains to Health Canada, FDA, ICH, EU MDD, ANVISA, CSA/UL, and ISO 9001/2015. Rany holds MBA specialization in Pharmaceutical management with a Degree in Veterinary Medicine. Also, Rany is a certified Quality Auditor from American Society for Quality (ASQ), Lead Auditor (TPECS) from British standards Institution (bsi). Rany is a Certified Black Belt Lean Six Sigma from Aveta Business Institute, USA.

Rany has been working as a Pharmaceutical Quality and Compliance Manager in different Multinational Pharmaceutical companies and also as Independent GMP & Auditing Consultant.