Instructor :
John E Lincoln

Webinar ID:
12452

In this 3-hour interactive webinar, you will gain a thorough understanding of the fundamentals of Quality Management Systems (QMS) through the lens of ISO 9001—the globally recognized standard for quality across industries.

This course is tailored to professionals looking to enhance their compliance strategies and improve operational excellence.

Key Takeaways Include:

• • A comprehensive overview of ISO 9001, focusing on core principles, common pitfalls, and best practices identified through regulatory inspections and audit findings.
  • Insights into how ISO 9001 principles seamlessly integrate with US Good Manufacturing Practices (GMPs), including 21 CFR 210 and 211—crucial for the pharmaceutical industry.
  • Understanding the ICH Q7 guidelines for GMPs in Active Pharmaceutical Ingredients (APIs), ensuring compliance across critical stages of production.
  • Practical strategies for preparing and conducting regulatory audits, focusing on key compliance areas that can impact your business.

By attending, you’ll gain actionable insights into implementing a robust QMS that not only meets international standards but also aligns with US FDA regulations, enabling you to reduce compliance risks and drive continuous improvement in your processes.

Join us for this highly focused and practical seminar designed to provide you with the tools you need to ensure quality excellence and regulatory readiness.

Enroll Now!

In this 3-hour interactive webinar, you will gain a thorough understanding of the fundamentals of Quality Management Systems (QMS) through the lens of ISO 9001—the globally recognized standard for quality across industries.

This course is tailored to professionals looking to enhance their compliance strategies and improve operational excellence.

Key Takeaways Include:

• • A comprehensive overview of ISO 9001, focusing on core principles, common pitfalls, and best practices identified through regulatory inspections and audit findings.
  • Insights into how ISO 9001 principles seamlessly integrate with US Good Manufacturing Practices (GMPs), including 21 CFR 210 and 211—crucial for the pharmaceutical industry.
  • Understanding the ICH Q7 guidelines for GMPs in Active Pharmaceutical Ingredients (APIs), ensuring compliance across critical stages of production.
  • Practical strategies for preparing and conducting regulatory audits, focusing on key compliance areas that can impact your business.

By attending, you’ll gain actionable insights into implementing a robust QMS that not only meets international standards but also aligns with US FDA regulations, enabling you to reduce compliance risks and drive continuous improvement in your processes.

Join us for this highly focused and practical seminar designed to provide you with the tools you need to ensure quality excellence and regulatory readiness.

Enroll Now!

Quality Management Systems (QMS) are more critical than ever for maintaining regulatory compliance and ensuring product quality.

This seminar provides you with the tools and insights to excel in ISO 9001 standards and align with US FDA’s Good Manufacturing Practices (GMPs), setting you apart in your field.

Key Reasons to Attend:

• • Master ISO 9001 Fundamentals: Gain a deep understanding of the core requirements of ISO 9001 and learn how to apply them effectively to enhance quality control in manufacturing and other industries.
  • Bridge the Gap Between ISO 9001 and US FDA GMPs: Discover how ISO 9001 principles integrate with the US FDA’s GMPs, including 21 CFR 210 and 211. This knowledge is vital for pharmaceutical and manufacturing professionals seeking to ensure compliance with international and federal standards.
  • Overcome Common Quality Management Challenges: Learn how to address key challenges such as materials management, documentation accuracy, and validation—common pain points that can impact regulatory audits and operational efficiency.
  • Improve Your Audit Readiness: Develop skills in regulatory auditing and understand major areas of focus during ISO and FDA audits, helping you to minimize risks and avoid costly non-compliance issues.
  • Boost Your Career Potential: Stand out as a QMS expert and become a valuable asset to your organization by implementing best practices that drive continuous improvement and quality excellence.

This course is designed for Quality Managers, Compliance Officers, Regulatory Affairs Specialists, and Operations Managers looking to elevate their expertise in quality management and regulatory compliance.

Don’t miss this opportunity to build a solid foundation in ISO 9001 and FDA GMPs, and gain practical knowledge that will directly impact your career growth and organization’s success.

Enroll Now!

Quality Management Systems (QMS) are more critical than ever for maintaining regulatory compliance and ensuring product quality.

This seminar provides you with the tools and insights to excel in ISO 9001 standards and align with US FDA’s Good Manufacturing Practices (GMPs), setting you apart in your field.

Key Reasons to Attend:

• • Master ISO 9001 Fundamentals: Gain a deep understanding of the core requirements of ISO 9001 and learn how to apply them effectively to enhance quality control in manufacturing and other industries.
  • Bridge the Gap Between ISO 9001 and US FDA GMPs: Discover how ISO 9001 principles integrate with the US FDA’s GMPs, including 21 CFR 210 and 211. This knowledge is vital for pharmaceutical and manufacturing professionals seeking to ensure compliance with international and federal standards.
  • Overcome Common Quality Management Challenges: Learn how to address key challenges such as materials management, documentation accuracy, and validation—common pain points that can impact regulatory audits and operational efficiency.
  • Improve Your Audit Readiness: Develop skills in regulatory auditing and understand major areas of focus during ISO and FDA audits, helping you to minimize risks and avoid costly non-compliance issues.
  • Boost Your Career Potential: Stand out as a QMS expert and become a valuable asset to your organization by implementing best practices that drive continuous improvement and quality excellence.

This course is designed for Quality Managers, Compliance Officers, Regulatory Affairs Specialists, and Operations Managers looking to elevate their expertise in quality management and regulatory compliance.

Don’t miss this opportunity to build a solid foundation in ISO 9001 and FDA GMPs, and gain practical knowledge that will directly impact your career growth and organization’s success.

Enroll Now!

• • Quality Management System (QMS) Overview:
    Understand the foundational principles of a QMS, including how ISO 9001 standards apply to various industries, with a focus on manufacturing.
  • Systems, Personnel, and Physical Plant:
    Learn how to structure systems effectively, optimize personnel roles, and manage the physical environment to maintain compliance and operational efficiency.
  • Documentation Essentials: “If It Isn’t Documented, It Didn’t Happen”:
    Master best practices for documentation and record-keeping to ensure traceability, audit readiness, and regulatory compliance.
  • Control of Materials, Products, and Manufacturing Processes:
    Discover effective strategies for managing materials, product control, and manufacturing processes to ensure consistent quality throughout the production lifecycle.
  • Laboratory Controls:
    Gain insights into laboratory best practices, including quality testing and data management to support product integrity and regulatory standards.
  • Validation Processes:
    Understand the importance of process validation, including methods for equipment qualification, process validation, and ongoing monitoring to meet ISO and FDA requirements.
  • Material/Product Rejection and Release:
    Explore procedures for handling non-conforming materials, rejections, and release criteria to ensure quality and safety before product distribution.
  • Complaint Handling and Post-Production Issues:
    Learn best practices for complaint management, adverse event reporting, and addressing post-production challenges to enhance customer satisfaction and regulatory compliance.
  • Preparing for a Regulatory Audit of the QMS:
    Get practical tips on navigating regulatory audits, understanding key focus areas for ISO and FDA inspections, and ensuring your QMS is audit-ready.

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

• • Quality Management System (QMS) Overview:
    Understand the foundational principles of a QMS, including how ISO 9001 standards apply to various industries, with a focus on manufacturing.
  • Systems, Personnel, and Physical Plant:
    Learn how to structure systems effectively, optimize personnel roles, and manage the physical environment to maintain compliance and operational efficiency.
  • Documentation Essentials: “If It Isn’t Documented, It Didn’t Happen”:
    Master best practices for documentation and record-keeping to ensure traceability, audit readiness, and regulatory compliance.
  • Control of Materials, Products, and Manufacturing Processes:
    Discover effective strategies for managing materials, product control, and manufacturing processes to ensure consistent quality throughout the production lifecycle.
  • Laboratory Controls:
    Gain insights into laboratory best practices, including quality testing and data management to support product integrity and regulatory standards.
  • Validation Processes:
    Understand the importance of process validation, including methods for equipment qualification, process validation, and ongoing monitoring to meet ISO and FDA requirements.
  • Material/Product Rejection and Release:
    Explore procedures for handling non-conforming materials, rejections, and release criteria to ensure quality and safety before product distribution.
  • Complaint Handling and Post-Production Issues:
    Learn best practices for complaint management, adverse event reporting, and addressing post-production challenges to enhance customer satisfaction and regulatory compliance.
  • Preparing for a Regulatory Audit of the QMS:
    Get practical tips on navigating regulatory audits, understanding key focus areas for ISO and FDA inspections, and ensuring your QMS is audit-ready.

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Everybody benefits from watching this. Even better when done as a group!

• • Quality Managers Seeking to Enhance Compliance with ISO 9001 standards and ensure seamless integration with US FDA GMPs.
  • Regulatory Affairs Specialists Aiming to Stay Audit-Ready, minimizing non-compliance risks during ISO or FDA inspections.
  • Operations Managers Looking to Improve Efficiency in materials management and manufacturing processes.
  • Manufacturing Supervisors Striving to Maintain Product Quality, ensuring adherence to validation processes and laboratory controls.
  • Training Managers Who Want to Equip Teams with practical skills in quality management and regulatory compliance.
  • HR Professionals Focused on Building a Culture of Compliance by ensuring employees understand critical quality standards.
  • Project Managers Who Need to Align Production with ISO and GMP requirements, delivering consistent product quality.
  • New Quality Assurance Staff Looking to Quickly Gain Expertise in QMS fundamentals and regulatory requirements.
  • Business Owners Seeking to Minimize Compliance Risks while maintaining high standards of product quality and customer satisfaction.

Everybody benefits from watching this. Even better when done as a group!

• • Quality Managers Seeking to Enhance Compliance with ISO 9001 standards and ensure seamless integration with US FDA GMPs.
  • Regulatory Affairs Specialists Aiming to Stay Audit-Ready, minimizing non-compliance risks during ISO or FDA inspections.
  • Operations Managers Looking to Improve Efficiency in materials management and manufacturing processes.
  • Manufacturing Supervisors Striving to Maintain Product Quality, ensuring adherence to validation processes and laboratory controls.
  • Training Managers Who Want to Equip Teams with practical skills in quality management and regulatory compliance.
  • HR Professionals Focused on Building a Culture of Compliance by ensuring employees understand critical quality standards.
  • Project Managers Who Need to Align Production with ISO and GMP requirements, delivering consistent product quality.
  • New Quality Assurance Staff Looking to Quickly Gain Expertise in QMS fundamentals and regulatory requirements.
  • Business Owners Seeking to Minimize Compliance Risks while maintaining high standards of product quality and customer satisfaction.