Master Fundamentals of Good Manufacturing Practices (GMPs) : Maximize Product Quality and Minimize Risks
Unlock the Secrets of Effective Quality Control with Fundamentals of GMPs Training!
Instructor :
Charles H. Paul
Webinar ID:
8147
Date: 21 July 23, FRI
Start Time: 9 am PT
Duration: 4 Hrs.
What you will learn
- Complex Regulatory Requirements and How to Adhere to Them Systematically
- Essential Elements of GMPs and Their Significance
- Quality Management, Personnel, Premises and Equipment
- Documentation, Production, Quality…
- Complex Regulatory Requirements and How to Adhere to Them Systematically
- Essential Elements of GMPs and Their Significance
- Quality Management, Personnel, Premises and Equipment
- Documentation, Production, Quality Assurance
- Materials management, Production and In-Process Controls
- Packaging and Labeling, Storage and Distribution
- Laboratory controls, Validation, Change Control
- Rejection and Re-use of Material, Complaints and Recalls, Supplier Controls
Course Description
With manufacturing complexities and regulatory standards continually evolving, ensuring adherence to Good Manufacturing Practices (GMPs) has never been more critical.
Organizations that prioritize adherence to Good Manufacturing Practices experience an average of 33% reduction in product defects and a significant increase in customer satisfaction. These statistics underline the transformative impact of GMPs on operational excellence and the bottom line.
GMPs minimize the risks associated with processing and manufacturing products. Every country, including the US with the FDA, has its own set of governing GMP regulations. Some of these regulations are harmonized with others, while some are not.
These regulations are not guidelines…they have the weight of law. They essentially dictate how work and the workers executing that work must conduct their work activities. GMPs touch upon virtually every aspect of work life and the processes that are performed as integral components of that work.
GMPs govern the methods used in, and the facilities and controls used for:
- The design, manufacture
- Packaging, labeling,
- Storage, installation, and servicing of all finished products intended for human use.
The purpose of these regulation? It is very simple – to ensure that medical/medicinal are safe and effective.
Achieving this safety and effectiveness requirement however is not so simple. It is achieved by implementing what is known as a Quality System consisting of many regulatory requirements as specified in the governing regulations that must be:
- Documented in the form of Standard Operating Procedures and Work Instructions
- Integrated into the fabric of how the business executes the activities required to place a medical/medicinal product into the marketplace
- Be managed on a daily basis to ensure the organization’s compliance to the tenants of the regulation
- Be provable when externally audited to verify its effectiveness and compliance with the regulation
Charles H. Paul will guide you on how exactly you can achieve it successfully. This intensive training aims to:
- Enhance your understanding of GMPs
- Equipping you with the essential tools and knowledge to uphold the highest manufacturing standards within your organization
Enroll Now!
With manufacturing complexities and regulatory standards continually evolving, ensuring adherence to Good Manufacturing Practices (GMPs) has never been more critical.
Organizations that prioritize adherence to Good Manufacturing Practices experience an average of 33% reduction in product defects and a significant increase in customer satisfaction. These statistics underline the transformative impact of GMPs on operational excellence and the bottom line.
GMPs minimize the risks associated with processing and manufacturing products. Every country, including the US with the FDA, has its own set of governing GMP regulations. Some of these regulations are harmonized with others, while some are not.
These regulations are not guidelines…they have the weight of law. They essentially dictate how work and the workers executing that work must conduct their work activities. GMPs touch upon virtually every aspect of work life and the processes that are performed as integral components of that work.
GMPs govern the methods used in, and the facilities and controls used for:
- The design, manufacture
- Packaging, labeling,
- Storage, installation, and servicing of all finished products intended for human use.
The purpose of these regulation? It is very simple – to ensure that medical/medicinal are safe and effective.
Achieving this safety and effectiveness requirement however is not so simple. It is achieved by implementing what is known as a Quality System consisting of many regulatory requirements as specified in the governing regulations that must be:
- Documented in the form of Standard Operating Procedures and Work Instructions
- Integrated into the fabric of how the business executes the activities required to place a medical/medicinal product into the marketplace
- Be managed on a daily basis to ensure the organization’s compliance to the tenants of the regulation
- Be provable when externally audited to verify its effectiveness and compliance with the regulation
Charles H. Paul will guide you on how exactly you can achieve it successfully. This intensive training aims to:
- Enhance your understanding of GMPs
- Equipping you with the essential tools and knowledge to uphold the highest manufacturing standards within your organization
Enroll Now!
Why you should attend
Overlooking the importance of GMP for regulated medicinal products is a big mistake!
According to a study by the National Bureau of Economic Research, firms that comply with stringent manufacturing practices have 10% higher productivity rates and up to 15% higher profitability. Additionally, non-compliance can result in costly recalls, damaging both reputation and bottom line.
Your understanding and application of GMPs can make a significant difference in maintaining high-quality production, reducing errors, and strengthening your market position.
If you work within regulated medical product industries, almost everything that you do every day is somehow touched by this regulation.
Ignorance of the sections of this regulation is no excuse for non-compliance. It takes a complete thorough understanding of the regulation to ensure your compliance to it.
By the end of this interactive webinar, participants will:
- Learn: Gain comprehensive knowledge of the essential elements of GMPs and their significance in the manufacturing landscape.
- Understand: Unpack the complex regulatory requirements and learn how to adhere to them systematically.
- Improve: Enhance your operational efficiency by implementing GMPs, resulting in higher quality products and lesser manufacturing errors.
- Lead: Set a benchmark for high-quality manufacturing practices in your organization, fostering a culture of compliance and excellence.
- Grow: By adhering to GMPs, you’ll minimize regulatory risks, protect your company’s reputation, and drive sustainable business growth
Join Now!
Overlooking the importance of GMP for regulated medicinal products is a big mistake!
According to a study by the National Bureau of Economic Research, firms that comply with stringent manufacturing practices have 10% higher productivity rates and up to 15% higher profitability. Additionally, non-compliance can result in costly recalls, damaging both reputation and bottom line.
Your understanding and application of GMPs can make a significant difference in maintaining high-quality production, reducing errors, and strengthening your market position.
If you work within regulated medical product industries, almost everything that you do every day is somehow touched by this regulation.
Ignorance of the sections of this regulation is no excuse for non-compliance. It takes a complete thorough understanding of the regulation to ensure your compliance to it.
By the end of this interactive webinar, participants will:
- Learn: Gain comprehensive knowledge of the essential elements of GMPs and their significance in the manufacturing landscape.
- Understand: Unpack the complex regulatory requirements and learn how to adhere to them systematically.
- Improve: Enhance your operational efficiency by implementing GMPs, resulting in higher quality products and lesser manufacturing errors.
- Lead: Set a benchmark for high-quality manufacturing practices in your organization, fostering a culture of compliance and excellence.
- Grow: By adhering to GMPs, you’ll minimize regulatory risks, protect your company’s reputation, and drive sustainable business growth
Join Now!
Areas Covered
- What are the regulations governing Good Manufacturing Practices?
- Quality Management
- Personnel
- Premises and equipment
- Documentation
- Production
- Quality Assurance
- Materials management
- Production and in-process controls
- Packaging and labeling
- Storage and distribution
- Laboratory controls
- Validation
- Change control
- Rejection and re-use of material
- Complaints and recalls
- Supplier controls
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.
- What are the regulations governing Good Manufacturing Practices?
- Quality Management
- Personnel
- Premises and equipment
- Documentation
- Production
- Quality Assurance
- Materials management
- Production and in-process controls
- Packaging and labeling
- Storage and distribution
- Laboratory controls
- Validation
- Change control
- Rejection and re-use of material
- Complaints and recalls
- Supplier controls
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!
Anyone involved in the production of GMP regulated medicinal products – pharmaceuticals, medical devices, and biologics!
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
Maximize The Learning Experience in A Group Setting!
Anyone involved in the production of GMP regulated medicinal products – pharmaceuticals, medical devices, and biologics!
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 to the life sciences industry 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 human performance and compliance-related problems.
