San Francisco, California
London, United Kingdom
This two-day course focuses on the processes associated with the acquisition of products, materials and services that fuel and support the organization’s product manufacturing and marketing. These cross-functional processes are complex and result in conflicting objectives between decision-makers. Management is responsible for organizing and providing resources and the more they understand, the more effectively they can manage. This course begins with a discussion about quality and compliance and some of the regulations pertinent to supplier/contractor qualification and control. The primary regulations are:
- Part 211, Subpart E-Control of Components and Drug Product Containers and Closures, ICH Q7A, Section VII, Materials Management Part 820, Subpart F, Purchasing Controls.
- ISO 13485:2016, ISO 9001:2015, pertinent ICH & IMDRF (formerly GHTF) documents and pertinent FDA guidance documents. Quality concepts from “quality gurus” will also be presented.
- Contract Testing Laboratories
- Part 58, Good Laboratory Practices, (GLP) contractors.
Next, the course discusses how functions and personnel must be organized and an infrastructure established to ensure the “building blocks” of the products meet processing requirements and produce products that meet customer requirements. Management provides resources that ensure that these activities are properly managed and personnel are in place who have experience, qualifications, and knowledge to carry out the responsibilities. Procedures must exist that provides direction and structure to the process.
After the organization and infrastructure are in place, it must be implemented. So the next topic is a very detailed presentation and discussion of the entire qualification process beginning with the creation of the specification followed by a series of tasks that include testing material samples, researching and analyzing potential candidates, planning and conducting an audit. The audit data must be analyzed and used to form a conclusion concerning the qualification status. These activities must be monitored.
Finally, case studies, warning letters, experiences of the speaker will be presented. Class activities will encourage your participation.
Note: Attendees will receive electronic documentation that includes an SOP for auditing and qualifying suppliers and contractors, supplier rating, audit and qualification tracking form, targeted industry specific questionnaires, samples of specification’s forms and other boilerplate documents.
Who will Benefit:
- Because the qualification process is multi-functional, Quality, Production, Purchasing, R&D, Document Control, etc. will benefit by attending this seminar.
- Management can better understand their responsibilities as they oversee multi-functional characteristic S/C qualification and control.
- Those functions who have the greatest potential to gain from this seminar include, for example:
- Audit Team Leaders will gain insight into the multi-functional processes they lead
- Audit Team Members will gain insight that will help them better understand the role and how the process functions leading to potential increased responsibility.
- Provide knowledge to auditors seeking certification
- Quality (QA & QC) and Regulatory Affair are the major drivers of qualification
- QC will learn more about the requirements for testing & sampling activities, material qualification, and incoming controls.
- QA will gain knowledge and insight in their decision-making concerning specification approvals, evaluating suppliers/contractors, corrective action plans, material validation,
- Documentation Control will gain insight on the processing of material specifications, establishing supplier files, and handling of audit related documentation
- Purchasing will better understand their role as an intermediary between the company and the supplier and contractor.
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.