Managing the complex lifecycle of combination products requires the efficient utilization of resources of a pharma/device company regardless if the company is vertically integrated, utilizes bth in-house and contract manufacturing, or is a truly virtual company.
Part 1 of this will define and apply recognized risk management principles in the identification of required GMP’s and Quality Systems Regulations, developing a risk-based, tiered supplier and material qualification system, and developing effective Master Supply Agreements and Request for Quotations (RFQ’s).
The course is appropriate for all operations, quality, development, and project management functional areas but will emphasize the perspective of Engineering and Good Engineering Practices where applicable.
Upon completion of this course, you will be able to:
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This course is intended for professionals involved in the Pharmaceutical, Medical Device, Biopharma and Biologics industries.
Managers, Directors, and Specialists working in Engineering, Supply Chain, Manufacturing, Packaging, QA/QC and Project Management will benefit greatly by attending this training.
All operations, quality, development, and project management personnel who are involved in ensuring Good Engineering Practices should attend.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.Learn more
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