Mastering GMP Fundamentals: Elevate Product Quality and Minimize Risks Amid 2024 FDA Changes
Are Your GMP Protocols Robust Enough to Meet The Upcoming QMSR Requirements?
Instructor :
Charles H. Paul
Webinar ID:
9392
Date: JAN 03, 2024 (FRI)
Start Time: 9 AM PT - 1 PM PT
Duration: 4 Hrs.
What you will learn
-
- Quality Management: Establish The Backbone For Consistent Production Excellence.
- Skilled Personnel: Ensure Every Hand In The Process Is Competent.
- Facilities And Equipment: Build A Solid Foundation For Quality Production.
- Materials And Documentation: Meticulously Manage Resources And Maintain Detailed Records.
- Production Control: Monitor In-Process Activities For Flawless, High-Quality Results.
- Quality Assurance: Double-Check Processes And Confirm Effectiveness With Validation.
- Change Control: Seamlessly Manage Modifications To Maintain Compliance.
- Packaging And Distribution: Ensure Safe Delivery And ….
-
- Quality Management: Establish The Backbone For Consistent Production Excellence.
- Skilled Personnel: Ensure Every Hand In The Process Is Competent.
- Facilities And Equipment: Build A Solid Foundation For Quality Production.
- Materials And Documentation: Meticulously Manage Resources And Maintain Detailed Records.
- Production Control: Monitor In-Process Activities For Flawless, High-Quality Results.
- Quality Assurance: Double-Check Processes And Confirm Effectiveness With Validation.
- Change Control: Seamlessly Manage Modifications To Maintain Compliance.
- Packaging And Distribution: Ensure Safe Delivery And Accurate Product Labeling.
- Handling Issues: Address Complaints, Recalls, And Re-Use Materials Responsibly.
Course Description
Good Manufacturing Practices (GMPs) are more than just regulatory requirements—they are the cornerstone of product excellence.
With the 2024 FDA Quality Management System Regulation (QMSR) aligning with ISO 13485:2016, there’s a pivotal shift in ensuring product quality and compliance.
Course Highlights:
-
- Comprehensive Overview: Gain a clear understanding of the latest FDA updates and their impact on GMP compliance.
- Global Standards Alignment: Learn how the harmonization with international standards affects your operations.
- Risk Management: Dive into the new requirements for risk management across the product lifecycle.
- Enhanced Quality Systems: Learn to effectively integrate the updated QMSR into your existing quality systems.
Course Benefits:
-
- Reduce Product Recalls: Utilize GMP compliance to achieve up to a 40% reduction in product recalls.
- Expert Guidance: Learn from Charles H. Paul, a renowned expert in GMP and quality management.
- Practical Implementation: Obtain actionable insights on implementing robust GMP protocols and avoiding common compliance pitfalls.
Why This Course?
In the evolving regulatory landscape, staying ahead of GMP updates is crucial. This course, led by industry expert Charles H. Paul, equips you with the tools and knowledge to elevate product quality and ensure unwavering compliance.
From design and manufacture to packaging, labeling, storage, and installation, GMP principles are integrated into every aspect of product development and distribution.
Enroll now to secure your spot in this essential training and ensure your products meet the highest standards of safety and effectiveness.
Don’t wait—elevate your product quality to the GMP Gold Standard today!
Good Manufacturing Practices (GMPs) are more than just regulatory requirements—they are the cornerstone of product excellence.
With the 2024 FDA Quality Management System Regulation (QMSR) aligning with ISO 13485:2016, there’s a pivotal shift in ensuring product quality and compliance.
Course Highlights:
-
- Comprehensive Overview: Gain a clear understanding of the latest FDA updates and their impact on GMP compliance.
- Global Standards Alignment: Learn how the harmonization with international standards affects your operations.
- Risk Management: Dive into the new requirements for risk management across the product lifecycle.
- Enhanced Quality Systems: Learn to effectively integrate the updated QMSR into your existing quality systems.
Course Benefits:
-
- Reduce Product Recalls: Utilize GMP compliance to achieve up to a 40% reduction in product recalls.
- Expert Guidance: Learn from Charles H. Paul, a renowned expert in GMP and quality management.
- Practical Implementation: Obtain actionable insights on implementing robust GMP protocols and avoiding common compliance pitfalls.
Why This Course?
In the evolving regulatory landscape, staying ahead of GMP updates is crucial. This course, led by industry expert Charles H. Paul, equips you with the tools and knowledge to elevate product quality and ensure unwavering compliance.
From design and manufacture to packaging, labeling, storage, and installation, GMP principles are integrated into every aspect of product development and distribution.
Enroll now to secure your spot in this essential training and ensure your products meet the highest standards of safety and effectiveness.
Don’t wait—elevate your product quality to the GMP Gold Standard today!
Why you should attend
Achieving and maintaining the GMP Gold Standard is crucial for the longevity and success of your business, especially in the pharmaceutical and medical device sectors.
Recent FDA updates, particularly the new Quality Management System Regulation (QMSR), emphasize the need to stay current with regulatory changes and international standards.
Why Attend This Webinar?
-
- Learn from Industry Leaders: Gain insights into best practices in GMP from experts with extensive industry experience.
- Prevent Compliance Issues: Identify and avoid costly compliance pitfalls and product quality failures.
- Stay Ahead of Regulatory Changes: Understand the latest FDA updates and learn how to align your operations with international standards like ISO 13485:2016.
Attendees of this webinar have reported significant improvements in their quality metrics, attributing these advancements to enhanced GMP understanding and application.
Ignoring these regulations won’t shield you from their implications. To ensure full compliance, you need a comprehensive grasp of every aspect.
This interactive webinar is designed to provide you with precise understanding and actionable guidance to implement in your organization.
Join Now! Don’t miss this opportunity to elevate your product quality to the GMP Gold Standard. Ensure your products meet the highest standards of safety and effectiveness in today’s competitive market.
By attending, you’ll not only stay compliant but also gain a competitive edge by adopting the latest best practices in GMP. Secure your spot and take a proactive step towards excellence in product quality.
Enroll Now!
Achieving and maintaining the GMP Gold Standard is crucial for the longevity and success of your business, especially in the pharmaceutical and medical device sectors.
Recent FDA updates, particularly the new Quality Management System Regulation (QMSR), emphasize the need to stay current with regulatory changes and international standards.
Why Attend This Webinar?
-
- Learn from Industry Leaders: Gain insights into best practices in GMP from experts with extensive industry experience.
- Prevent Compliance Issues: Identify and avoid costly compliance pitfalls and product quality failures.
- Stay Ahead of Regulatory Changes: Understand the latest FDA updates and learn how to align your operations with international standards like ISO 13485:2016.
Attendees of this webinar have reported significant improvements in their quality metrics, attributing these advancements to enhanced GMP understanding and application.
Ignoring these regulations won’t shield you from their implications. To ensure full compliance, you need a comprehensive grasp of every aspect.
This interactive webinar is designed to provide you with precise understanding and actionable guidance to implement in your organization.
Join Now! Don’t miss this opportunity to elevate your product quality to the GMP Gold Standard. Ensure your products meet the highest standards of safety and effectiveness in today’s competitive market.
By attending, you’ll not only stay compliant but also gain a competitive edge by adopting the latest best practices in GMP. Secure your spot and take a proactive step towards excellence in product quality.
Enroll Now!
Course Agenda
Empower Your Manufacturing Journey with a Deep Understanding of GMP!
-
- Quality Management: The Backbone of All Production
- Personnel: Ensuring Every Hand in the Process Is Skilled
- Premises and Equipment: Building the Foundation of Production
- Materials Management: Overseeing Resources Meticulously
- Documentation: Keeping Every Detail in Check
- Production: The Heart of GMP
- Production and In-Process Controls: Monitoring for Flawless Results
- Quality Assurance: Double-Checking for Perfection
- Validation: Confirming Processes’ Effectiveness
- Change Control: Managing Modifications Seamlessly
- Laboratory Controls: Validating Each Step Scientifically
- Supplier Controls: Ensuring Every Contributor Meets the Standard
- Packaging and Labeling: The Final Touch Before Products Meet Customers
- Storage and Distribution: Ensuring Safe Delivery
- Rejection and Re-Use of Material: Waste Not, Want Not
- Complaints and Recalls: Addressing Concerns Proactively
BONUS:
-
- PDF Copy of the Presentation Handout for Your Future Reference
- Soft Copy of the Certificate of Completion on Request
- Q&A Session with the Presenter: Get Your Pressing Questions Answered Verbally, via Chat or Email
Empower Your Manufacturing Journey with a Deep Understanding of GMP!
-
- Quality Management: The Backbone of All Production
- Personnel: Ensuring Every Hand in the Process Is Skilled
- Premises and Equipment: Building the Foundation of Production
- Materials Management: Overseeing Resources Meticulously
- Documentation: Keeping Every Detail in Check
- Production: The Heart of GMP
- Production and In-Process Controls: Monitoring for Flawless Results
- Quality Assurance: Double-Checking for Perfection
- Validation: Confirming Processes’ Effectiveness
- Change Control: Managing Modifications Seamlessly
- Laboratory Controls: Validating Each Step Scientifically
- Supplier Controls: Ensuring Every Contributor Meets the Standard
- Packaging and Labeling: The Final Touch Before Products Meet Customers
- Storage and Distribution: Ensuring Safe Delivery
- Rejection and Re-Use of Material: Waste Not, Want Not
- Complaints and Recalls: Addressing Concerns Proactively
BONUS:
-
- PDF Copy of the Presentation Handout for Your Future Reference
- Soft Copy of the Certificate of Completion on Request
- Q&A Session with the Presenter: Get Your Pressing Questions Answered Verbally, via Chat or Email
Who is this course for
Anyone involved in the production of GMP regulated medicinal products – pharmaceuticals, medical devices, and biologics!
Maximize the Learning Experience in A Group Setting!
NOTE: This webinar applies to all worker levels – Associates, Managers, Directors, Vice- Presidents.
Functions:
-
- Research & Development
- Technical Services
- Manufacturing
- Compliance and Regulatory
- Quality Assurance and Quality Control
- Logistics/Supply chain
- Service and Maintenance
- Marketing
Anyone involved in the production of GMP regulated medicinal products – pharmaceuticals, medical devices, and biologics!
Maximize the Learning Experience in A Group Setting!
NOTE: This webinar applies to all worker levels – Associates, Managers, Directors, Vice- Presidents.
Functions:
-
- Research & Development
- Technical Services
- Manufacturing
- Compliance and Regulatory
- Quality Assurance and Quality Control
- Logistics/Supply chain
- Service and Maintenance
- Marketing
Instructor Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
