Workshop Details

Dates

July 11, 2024

Time

2:00 pm – 4:00 pm

Cost

CAD $198.00 + HST (50% off of $395 – limited time only)

Location

Online

Deadline

July 4, 2024

Workshop Overview

This webinar delves into the history, rationale, purpose, and GMP requirements applicable to the manufacturing, packaging, labeling, testing, and control of pharmaceutical products. Participants will gain practical knowledge of the essential elements and quality systems necessary for GMP compliance in the pharmaceutical industry. Additionally, the webinar will explore the consequences of non-compliance, equipping attendees with the insights needed to maintain high standards and ensure product integrity. Join us to enhance your understanding of GMP principles and their application in maintaining compliance and quality in pharmaceutical operations.

Who Should Attend​

This workshop is designed for Directors, Managers, Supervisors, and Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices, and allied industries. It is particularly valuable for professionals involved in Regulatory Affairs, Clinical Research, Quality Assurance, Documentation and Technical Writing, Product Submission, Project Management, Training, and Product Development. Additionally, consultants and other stakeholders who collaborate to launch products will benefit from this comprehensive overview of GMP requirements and compliance.

Workshop Outline

This workshop covers the following topics:

  • Ensuring Quality in the Workplace
  • Benefits of GMP Compliance
  • Management Responsibilities for GMP
  • Principles of Drug Production and SISPQ
  • Core Principles of GMP
  • Effective Training Requirements
  • Comprehensive GMP Documentation
  • Standard Operating Procedures (SOPs)
  • Quality Control and Quality Assurance
  • Developing Methods and Specifications
  • Implementing Sanitation Programs
  • Investigating Out of Specification Results and Deviations
  • Establishing Production Controls
  • Best Practices for Good Documentation
  • Accurate Record Keeping
  • Types of Validation
  • Implementing Effective Change Control
  • Current Industry Trends
  • Best Practices for Hosting Inspectors and Auditors

Learning Outcomes

Mastery of GMP Principles:

Understand the foundational principles of Good Manufacturing Practices (GMP) and their significance in ensuring product quality and regulatory compliance in pharmaceutical manufacturing.

Proficiency in Documentation and Record Keeping:

Develop the skills needed to create comprehensive GMP documentation, including standard operating procedures (SOPs), training materials, and validation protocols, and maintain accurate records in compliance with regulatory requirements.

Effective Quality Control and Assurance:

Gain expertise in implementing quality control and assurance measures, including methods development, specification setting, sanitation programs, and deviation investigations, to ensure product quality and safety throughout the manufacturing process.

Preparedness for Regulatory Inspections:

Learn best practices for hosting inspectors and auditors, including strategies for effective change control, validation, and addressing industry trends, to ensure readiness for regulatory inspections and maintain GMP compliance.

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

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

Annual GMP Masterclass

July 11, 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.