Quality Control Standards As Per cGMP & cGLP Guidelines

Quality Control Standards As Per cGMP & cGLP Guidelines

November 27, 2024 11:00 AM EST 90 Minutes

Presented By: Ginette Collazo

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Description

This webinar will focus on the critical quality control standards required by current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP). Both sets of guidelines are essential for ensuring the integrity, consistency, and safety of pharmaceutical products and laboratory procedures. cGMP outlines the regulatory standards for the manufacturing, processing, and packaging of drugs, while cGLP governs the practices within non-clinical laboratory studies. Attendees will gain an understanding of how these guidelines establish the framework for compliance, quality assurance, and maintaining product safety across the lifecycle of development and manufacturing.

Learning Objectives:-

  • Understand cGMP & cGLP fundamentals.
  • Learn key regulatory compliance requirements.
  • Explore risk mitigation strategies for product safety.
  • Discover best practices for implementing quality control standards.
  • Stay updated on industry trends and regulatory changes.

Areas Covered:-

  • Overview of cGMP and cGLP guidelines.
  • Key differences between cGMP and cGLP.
  • Regulatory requirements for quality control in manufacturing and laboratory settings.
  • Risk management and compliance strategies.
  • Best practices for ensuring product quality and safety.
  • Common challenges in implementing cGMP and cGLP.
  • Updates on recent trends and changes in regulatory standards.

Why Should You Attend?

This webinar is a valuable opportunity for professionals involved in pharmaceuticals, biotechnology, and laboratory operations to deepen their understanding of the essential quality control standards dictated by cGMP and cGLP guidelines. By attending, participants will learn how to ensure compliance, enhance product safety, and improve operational efficiency.

Whether you’re responsible for production, quality assurance, or regulatory affairs, this session will provide actionable insights to help you meet regulatory requirements and uphold the highest quality standards in your processes.

Who will Benefit?

  • Pharmaceutical and biotechnology professionals.
  • Quality control and assurance teams.
  • Laboratory personnel in non-clinical research.
  • Manufacturing managers and supervisors.
  • Regulatory affairs specialists.
  • Compliance officers and auditors.
  • Professionals in the food and beverage industry.
  • Cosmetic and personal care product manufacturers.

Know Your Presenter

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with over 20 years of experience specializing in Engineering Psychology and Human Reliability. She has held positions leading Training and Human Reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry. In 2009, Dr. Collazo established Human Error Solutions (HES), a training and consulting firm, and she has positioned herself as one of the few Human Error Reduction Experts worldwide. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development, and effectiveness implemented and proven amongst different industries globally. Furthermore, this scientific method has been applied in critical quality situations and workplace accidents. As a GMP expert, she has also been a Keynote Speaker at significant events worldwide. Ginette Collazo, Ph. D., is the author of several books, “Human Error: Root Cause Determination Model” and “Mission Matters: World Leading Entrepreneurs Reveal their Top Tips to Success.” In 2023, Human Error Solutions was named as a top ten industrial service provider by Manufacturing Outlook magazine and featured in ABC, Fox, NBC, and CBS news. She hosts The Power of Why Podcast—a show about human behavior in the workplace and critical thinking.