ICH Q10- Establishing The Pharmaceutical Quality System
Duration : 60 Minutes
Todd Graham,
Todd Graham , is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields. He has work for a number of start-up firms in the clinical diagnostics and biotechnology industries, as well as worked for larger firms within both industries. He has a Read more
ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified be regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional. ICH Q10 demonstrates industry and regulatory authorities’ support of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of ICH Q10 throughout the product life cycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.
Since 1990, the International Committee on Harmonization (ICH) has been working to coordinate regulations for pharmaceuticals throughout the world. This webinar will cover the latest update to the ICH Q10 model guidelines and cover what are the important changes that will be promulgated throughout the world.
Course Objectives:
While marketing products all over the world, there will be a need to deal with the regulatory systems of various nations. The ICH Q10 rules are an effort to minimize the differences between these regulatory systems to simplify the submission process. Aligning your quality system with these rules will make life easier. You can ensure that the information that your company has on the development process can be used in multiple contexts without the need to reformat information or perform additional work.
Course Outline:
• Objectives of ICH Q10
• Enablers of ICH Q10
• Management responsibilities
• Life Cycle Management
• Pharmaceutical Quality System Management
• Continuous Improvement of the Quality System
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Management Personnel
• Quality Personnel
• Regulatory Affairs Personnel
• Production Personnel
• Regulatory Affairs
• Quality Control/Quality Assurance
• Quality Auditors
• Compliance Personnel
• Quality Engineers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
