2-Day Virtual GMP Master Class – Get It Right the First Time, Every Time to Avoid Compliance Issues
Gain Critical Insights Into Effective GMP Implementation & The Latest Regulatory Changes!
Instructor :
Charles H. Paul
Webinar ID:
10886
Date: JAN 06-07, 2025 (MON-TUE)
Start Time: 9 AM PT - 1 PM PT each day
Duration: 8 Hrs.
What you will learn
-
- Explore Key Regulations Governing Good Manufacturing Practices (GMPs).
- Understand Your Responsibilities Under the GMP Regulatory Framework.
- Learn About Critical GMP Topics from the Federal Regulations.
- Enhance Knowledge on Quality Management and Personnel Requirements.
- Master Documentation and Robust Production Oversight Processes.
- Focus on Quality Assurance and Materials ….
-
- Explore Key Regulations Governing Good Manufacturing Practices (GMPs).
- Understand Your Responsibilities Under the GMP Regulatory Framework.
- Learn About Critical GMP Topics from the Federal Regulations.
- Enhance Knowledge on Quality Management and Personnel Requirements.
- Master Documentation and Robust Production Oversight Processes.
- Focus on Quality Assurance and Materials Management Strategies.
- Dive Into Specifics of Packaging, Labeling, and Distribution.
- Study Laboratory Controls, Validation, and Change Control Systems.
- Prepare Effectively for GMP Inspections and FDA Reviews.
- Develop Skills for Handling FDA Inspections and Ensuring Compliance
Course Description
Current Good Manufacturing Practices (CGMPs) are not just regulations—they are essential frameworks that ensure the safety, quality, and efficacy of pharmaceutical products.
Understanding and implementing these practices is crucial for any organization aiming to maintain compliance and achieve operational excellence in the life sciences industry.
Why This Master Class is Essential:
- Comprehensive CGMP Coverage:
- This master class provides an in-depth exploration of all facets of life sciences manufacturing processes and facilities.
- Learn how to control operations to maintain the identity, strength, quality, and purity of drug products.
- Expert-Led Insights:
- Dive into expert discussions on establishing robust quality management systems, sourcing quality raw materials, crafting effective operating procedures, and maintaining reliable testing laboratories.
- Real-World Applications:
- Engage with real-life case studies that illustrate the practical application of CGMPs.
- Understand how to detect and investigate product quality deviations and prevent contamination, mix-ups, and errors.
Course Highlights:
- Foundational Principles of CGMPs:
- Gain a solid foundation in the core principles of CGMPs and why they are the cornerstone of pharmaceutical manufacturing.
- Flexibility and Innovation in Compliance:
- Learn about the flexibility inherent in CGMP regulations that allows companies to use scientifically sound design, processing methods, and testing procedures.
- Discover how to leverage modern technologies and innovative approaches for continual improvement.
- Risk Management and Quality Assurance:
- Explore how beyond the minimum standards, many manufacturers implement comprehensive, modern quality systems and risk management approaches that exceed CGMP requirements.
Empower Your Compliance Strategy:
Join us to transform your understanding of CGMPs from a regulatory requirement into a competitive advantage.
Equip yourself with the knowledge to implement CGMPs effectively, ensuring your operations are compliant, efficient, and up-to-date with industry standards.
Join Now!
Current Good Manufacturing Practices (CGMPs) are not just regulations—they are essential frameworks that ensure the safety, quality, and efficacy of pharmaceutical products.
Understanding and implementing these practices is crucial for any organization aiming to maintain compliance and achieve operational excellence in the life sciences industry.
Why This Master Class is Essential:
- Comprehensive CGMP Coverage:
- This master class provides an in-depth exploration of all facets of life sciences manufacturing processes and facilities.
- Learn how to control operations to maintain the identity, strength, quality, and purity of drug products.
- Expert-Led Insights:
- Dive into expert discussions on establishing robust quality management systems, sourcing quality raw materials, crafting effective operating procedures, and maintaining reliable testing laboratories.
- Real-World Applications:
- Engage with real-life case studies that illustrate the practical application of CGMPs.
- Understand how to detect and investigate product quality deviations and prevent contamination, mix-ups, and errors.
Course Highlights:
- Foundational Principles of CGMPs:
- Gain a solid foundation in the core principles of CGMPs and why they are the cornerstone of pharmaceutical manufacturing.
- Flexibility and Innovation in Compliance:
- Learn about the flexibility inherent in CGMP regulations that allows companies to use scientifically sound design, processing methods, and testing procedures.
- Discover how to leverage modern technologies and innovative approaches for continual improvement.
- Risk Management and Quality Assurance:
- Explore how beyond the minimum standards, many manufacturers implement comprehensive, modern quality systems and risk management approaches that exceed CGMP requirements.
Empower Your Compliance Strategy:
Join us to transform your understanding of CGMPs from a regulatory requirement into a competitive advantage.
Equip yourself with the knowledge to implement CGMPs effectively, ensuring your operations are compliant, efficient, and up-to-date with industry standards.
Join Now!
Why you should attend
-
- Facing challenges with scalable GMP solutions in your growing business?
- Is the gap between regulatory knowledge and practical application widening?
- How robust are your strategies against the backdrop of global regulatory scrutiny?
If you’ve encountered any of these challenges, you cannot afford to miss this course.
Staying updated with Current Good Manufacturing Practices (GMPs) is not just a regulatory mandate—it’s a crucial element of maintaining high standards within your organization.
As GMP requirements are refreshed annually, understanding and applying these principles is key to avoiding costly regulatory issues.
Key Reasons to Register:
- Essential GMP Knowledge Refresh: GMP standards evolve, and keeping abreast of these changes is critical. This master class offers the latest insights and updates, ensuring you and your team are always informed.
- Prevent Compliance Risks: Learn the importance of regular training refreshers. Human nature leads us to forget or become careless over time—risks that are untenable in health sciences. This master class reinforces the GMP knowledge foundation, keeping your practices sharp and compliant.
- Expert-Led Insights: Gain from experts who understand the intricacies of GMPs and can guide you through the complexities of its application in real-world scenarios.
What You’ll Gain:
- Robust Understanding of GMPs: Deep dive into the GMP regulations and understand the pivotal role they play in maintaining the quality, safety, and efficacy of pharmaceutical products.
- Hands-On Application: Engage in practical exercises that reinforce the theoretical knowledge gained, ensuring you can apply GMPs effectively in your day-to-day operations.
- Networking Opportunities: Connect with peers across the industry, share challenges, and discuss solutions in an interactive virtual environment.
Professional and Operational Excellence:
This master class isn’t just a training—it’s a transformative experience designed to enhance your professional capabilities and operational excellence.
Whether you are a seasoned professional seeking a knowledge refresher or a newcomer to the field needing a solid foundation, this training is tailored to make compliance a seamless part of your operational strategy.
Invest in Your Professional Future:
Equip yourself with the knowledge and skills necessary to implement and maintain effective GMP systems, ensure ongoing compliance, and prevent errors due to oversight or forgetfulness.
Register now to secure your spot and make compliance your competitive advantage.
-
- Facing challenges with scalable GMP solutions in your growing business?
- Is the gap between regulatory knowledge and practical application widening?
- How robust are your strategies against the backdrop of global regulatory scrutiny?
If you’ve encountered any of these challenges, you cannot afford to miss this course.
Staying updated with Current Good Manufacturing Practices (GMPs) is not just a regulatory mandate—it’s a crucial element of maintaining high standards within your organization.
As GMP requirements are refreshed annually, understanding and applying these principles is key to avoiding costly regulatory issues.
Key Reasons to Register:
- Essential GMP Knowledge Refresh: GMP standards evolve, and keeping abreast of these changes is critical. This master class offers the latest insights and updates, ensuring you and your team are always informed.
- Prevent Compliance Risks: Learn the importance of regular training refreshers. Human nature leads us to forget or become careless over time—risks that are untenable in health sciences. This master class reinforces the GMP knowledge foundation, keeping your practices sharp and compliant.
- Expert-Led Insights: Gain from experts who understand the intricacies of GMPs and can guide you through the complexities of its application in real-world scenarios.
What You’ll Gain:
- Robust Understanding of GMPs: Deep dive into the GMP regulations and understand the pivotal role they play in maintaining the quality, safety, and efficacy of pharmaceutical products.
- Hands-On Application: Engage in practical exercises that reinforce the theoretical knowledge gained, ensuring you can apply GMPs effectively in your day-to-day operations.
- Networking Opportunities: Connect with peers across the industry, share challenges, and discuss solutions in an interactive virtual environment.
Professional and Operational Excellence:
This master class isn’t just a training—it’s a transformative experience designed to enhance your professional capabilities and operational excellence.
Whether you are a seasoned professional seeking a knowledge refresher or a newcomer to the field needing a solid foundation, this training is tailored to make compliance a seamless part of your operational strategy.
Invest in Your Professional Future:
Equip yourself with the knowledge and skills necessary to implement and maintain effective GMP systems, ensure ongoing compliance, and prevent errors due to oversight or forgetfulness.
Register now to secure your spot and make compliance your competitive advantage.
Course Agenda
Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?
-
- Contact us at support@compliancemeet.com to explore your options!
- We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.
A) Understanding GMPs and Regulatory Framework
- Overview of GMP Regulations: Explore the key regulations that govern Good Manufacturing Practices.
- Your Responsibilities: Understand your role in maintaining GMP standards.
- Key Topics in Federal Regulations: Dive deep into critical areas including:
- Quality Management
- Personnel Requirements
- Equipment and Premises
- Robust Documentation Practices
- Production Oversight
- Quality Assurance Mechanisms
- Materials Management
- In-process Controls and Production
- Packaging and Labeling Operations
- Storage and Distribution Protocols
- Laboratory Control Measures
- Validation Processes
- Change Control Systems
- Rejection and Reuse of Materials
- Managing Complaints and Recalls
- Supplier Quality Controls
B) GMP Inspection Preparedness
- Preparing for a GMP Inspection: Strategies to ensure readiness.
- Inspection Readiness and Consequences: Understand the implications of not being prepared.
- Focus Areas During Inspections: Highlight the specific elements that inspectors target.
C) Navigating FDA Inspections
- Structure and Conduct of FDA Inspections: Insights into how inspections are organized and executed.
- Preparing and Responding to FDA Inspections: Key strategies for effective response.
- Essentials of an Inspection:
- Truthfulness and its Importance
- Demonstrating Knowledge and Confidence
- Handling Elicitation Attempts by FDA
- Proper Behavior and Responses During Inspections
- The Critical Role of Documentation
- Effective Communication Techniques
- Understanding the Difference Between Opinion and Fact
- Recommended Phrases and Those to Avoid
- Managing Adverse Findings
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
Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?
-
- Contact us at support@compliancemeet.com to explore your options!
- We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.
A) Understanding GMPs and Regulatory Framework
- Overview of GMP Regulations: Explore the key regulations that govern Good Manufacturing Practices.
- Your Responsibilities: Understand your role in maintaining GMP standards.
- Key Topics in Federal Regulations: Dive deep into critical areas including:
- Quality Management
- Personnel Requirements
- Equipment and Premises
- Robust Documentation Practices
- Production Oversight
- Quality Assurance Mechanisms
- Materials Management
- In-process Controls and Production
- Packaging and Labeling Operations
- Storage and Distribution Protocols
- Laboratory Control Measures
- Validation Processes
- Change Control Systems
- Rejection and Reuse of Materials
- Managing Complaints and Recalls
- Supplier Quality Controls
B) GMP Inspection Preparedness
- Preparing for a GMP Inspection: Strategies to ensure readiness.
- Inspection Readiness and Consequences: Understand the implications of not being prepared.
- Focus Areas During Inspections: Highlight the specific elements that inspectors target.
C) Navigating FDA Inspections
- Structure and Conduct of FDA Inspections: Insights into how inspections are organized and executed.
- Preparing and Responding to FDA Inspections: Key strategies for effective response.
- Essentials of an Inspection:
- Truthfulness and its Importance
- Demonstrating Knowledge and Confidence
- Handling Elicitation Attempts by FDA
- Proper Behavior and Responses During Inspections
- The Critical Role of Documentation
- Effective Communication Techniques
- Understanding the Difference Between Opinion and Fact
- Recommended Phrases and Those to Avoid
- Managing Adverse Findings
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
Maximize the Learning Experience in A Group Setting!
This master class is designed for professionals in manufacturing, quality assurance, regulatory affairs, and operational management.
Whether you are looking to refresh your knowledge or are new to the field, this course will equip you with the essential tools and insights needed to implement and sustain effective GMP systems.
-
- Quality Assurance Managers
- Regulatory Affairs Specialists
- Manufacturing Supervisors/Managers
- Quality Control Technicians
- Compliance Officers
- Operations Managers
- Production Personnel
- Supply Chain Managers
- R&D Professionals
- Pharmaceutical Consultants
Maximize the Learning Experience in A Group Setting!
This master class is designed for professionals in manufacturing, quality assurance, regulatory affairs, and operational management.
Whether you are looking to refresh your knowledge or are new to the field, this course will equip you with the essential tools and insights needed to implement and sustain effective GMP systems.
-
- Quality Assurance Managers
- Regulatory Affairs Specialists
- Manufacturing Supervisors/Managers
- Quality Control Technicians
- Compliance Officers
- Operations Managers
- Production Personnel
- Supply Chain Managers
- R&D Professionals
- Pharmaceutical Consultants
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.
