Workshop Details

Dates

June 6, 2024

Time

1:00 pm – 3:00 pm

Cost

CAD $395 + HST

Location

Online

Deadline

May 30, 2024

Workshop Overview

In the Pharmaceutical industry, auditing contractors, vendors, and suppliers isn’t just a regulatory requirement—it’s a vital quality practice. Ensuring GMP compliance and robust Quality systems within these partnerships is crucial, yet often overlooked. Effective auditing is essential, guaranteeing that external entities meet the required quality standards, resulting in regulatory compliance and enhanced product quality. The role of an auditor in the pharmaceutical industry demands a diverse skill set—from the fundamentals of auditing to intricate technical knowledge across various areas such as classical chemical APIs, biological APIs, and different dosage forms. This workshop addresses these diverse needs by providing insights into technical areas and highlighting critical process steps essential for a comprehensive audit. Designed for both internal and external auditors, this course equips participants with the necessary skills to navigate the complexities of auditing in the pharmaceutical sector, covering aspects such as audit preparation, design, Data Integrity, and more. Join us for a structured approach to audit readiness, ensuring companies are consistently prepared and confident in their compliance efforts. Let’s embark on a journey towards controlled, stress-free audit readiness, ensuring companies are confident 100 percent of the time.

Who Should Attend​

This workshop is tailored for individuals regularly tasked with conducting audits on suppliers and/or internally, including quality assurance professionals and both internal and external auditors. It caters to anyone requiring an understanding of industry standards for auditing within the pharmaceutical and allied industries, especially those engaged in external supplier audits. Additionally, it is beneficial for Qualified Persons (QP) seeking to enhance their auditing proficiency.

Workshop Outline

This workshop covers the following topics:

  • The basics of auditing
  • Audit planning
  • Conducting audits
  • Effective auditing techniques
  • Audit analysis tools
  • Writing audit reports
  • Audit follow-up and closure
  • Examples and exercises will help to reinforce the workshop topics

Learning Outcomes

Audit Fundamentals

Learn the roles and responsibilities of auditors, various audit types, scheduling considerations, and the distinctions between internal and external audits.

Audit Planning and Preparation

Develop a deep understanding of the industry standards/regulations for audits, as well as audit administration, authority, scope, purpose, type, scheduling, checklist construction, and resource management.

Audit Performance

Discover the importance of conducting audit meetings, interviews, and data analysis. Learn how to document findings, enhance writing skills, and provide constructive feedback.

Audit Consolidation and Reports

Gain insight into the process of consolidating audit findings and preparing comprehensive reports. Additionally, learn about corrective actions, fostering continuous improvement, and ensuring departmental and management accountability.

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

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

GMP Audits, Inspections, Preparation and Management

June 6, 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.