Faculty: Meredith Crabtree ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3114


  • Date:4/2/2025 11:00 AM - 4/2/2025 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event

 

Description

This webinar provides an in-depth understanding of Pharmaceutical Quality Systems (PQS) and ICH Q10 Implementation. Participants will learn how to effectively apply ICH Q10 principles to enhance quality management, ensure compliance, and streamline manufacturing operations. Through real-world case studies and practical insights, attendees will gain actionable knowledge on implementing a robust quality system in their organizations.

This webinar is essential for professionals seeking to enhance their understanding of PQS and ICH Q10, improve regulatory compliance, and streamline pharmaceutical quality management. Participants will leave with practical insights and implementation strategies for ensuring a robust pharmaceutical quality system.


WHY YOU SHOULD ATTEND:

  • Understand the framework of PQS and ICH Q10 to ensure regulatory compliance.
  • Learn best practices for integrating PQS with manufacturing and quality operations.
  • Improve CAPA, change management, and quality review processes.
  • Gain insights into regulatory expectations and industry trends.


AREAS COVERED:

  • Comprehend the role of PQS in pharmaceutical quality assurance.
  • Break down the key elements of ICH Q10 and their implementation.
  • Understand how PQS & ICH Q10 improve risk management and compliance.
  • Learn strategies to align PQS with regulatory expectations.
  • Develop practical approaches for effective CAPA, change management, and process monitoring.


WHO SHOULD ATTEND:

  • Quality Assurance Departments
  • Quality Control Departments
  • Compliance Departments
  • Manufacturing Departments
  • Production Departments
  • Operations Departments
  • Regulatory Affairs Departments
  • Engineering Departments
  • Process Improvement Teams
  • Continuous Improvement Teams
  • Research and Development Departments
  • Product Development Specialists



Course Director: MEREDITH CRABTREE

 

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.