San Francisco, California
London, United Kingdom
In this two day workshop conference you will learn the different global agencies’ expectations of meeting the new guidelines. Different strategies for compliance will be presented with numerous illustrative examples. To place Q3D in context of other regulatory guidelines, a key segment on QbD principles, particularly risk assessment, will also be presented.
Upon completing this course participants should:
- Understand the regulatory agencies’ expectations for compliance of pharmaceuticals with ICH Q3D
- Understand the timelines and schedules for compliance
- Understand how to utilize a risk-based approach to address implementation of elemental impurities requirements
- Understand the general strategies for compliance, with pros and cons
- Develop an integrated, implementable plan for Regulatory, Manufacturing, and Quality to comply with ICH Q3D
- Understand the requirements for analytical instrumental methods to comply with ICH Q3D
- Understand the deliverables required of Regulatory affairs to comply
- Understand the depth and design of studies required of Manufacturing to comply
- Understand the documents required of Quality to comply
- Understand what is meant by Quality by Design
- Understand the benefits from applying a QbD approach
- Provide key steps to implement a QbD program
- Understand the important tools used to implement a QbD approach
Who will Benefit:
Implementation of Elemental Impurities testing is a shared responsibility between multiple functions in an organization.. Quality Managers will benefit greatly from this course due to their role in defining and defending the compliance aspects of these activities. R&D and Engineering will benefit due to their responsibility as Product Stewards. Regulatory has a significant role in providing updated product files to the authorities. These functions must understand the implications of their actions with respect to overall compliance. Other functions include:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production managers
- Manufacturing engineers
- Production engineers
- Design engineers and managers
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.