Auditing and Qualifying Training Course

Course Description – Course runs 9:00 to 5:00 both days (Breakfast  & Lunch Included)

The auditing and qualifying training course includes a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact (risk) to the final product. Regulatory agencies hold companies accountable for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the company's responsibility to ensure their suppliers/vendors meet all regulatory specifications for the supplied materials, components, equipment and/or services. Initially, the course will discuss the regulatory expectations and other industrial references/ standards that will impact your system and will include the general requirements of a vendor/supplier (outsourcing) control program followed by specific requirements for different types of supplied materials/equipment/services. During these sections, attendees will establish the documentation requirements, applicable audits and the impact of the quality agreement/contract details. For many years, the industry has implemented procedures for selection, approval and qualification of suppliers and vendors. However, in many cases these protocols were not being implemented effectively or formally documented. Making these programs part of a risk-based quality system approach that the FDA and other regulatory agencies have come to expect from industry is critical.

During the course, several interactive exercises will be included to provide opportunities for discussion and sharing of experiences.

Who Should Attend

The course will be valuable for those in the pharmaceutical, biotechnology and medical device industries who are responsible for, or involved in, supplier/vendor management, qualification, procurement or maintenance. Manufacturing, Research & Development, Validation and QA/RA personnel will benefit as the course details all the steps necessary to carefully document and conduct the process of vendor selection while working within the confines of a risk-based audit system.

Third-parties looking to gain insight into how firms select and manage their outside vendors will also find this course extremely useful.

Sean Develin

Sean Develin

Specialties: Regulatory

Sean Develin – with nearly 20 years in regulated industry – is co-founder of DevRose Systems. This UK and US-based consultancy provides information technology, validated cloud, auditing and compliance services to regulated clients worldwide. He is also an adjunct faculty member of the Temple University School of Pharmacy; where he teaches Bioethics, Auditing and Validation.

Prior to launching DevRose Systems, Mr. Develin built and managed the validation practice for Falcon Consulting Group and was Director of Validation for Omnicare Clinical Research. His expertise ranges from human research protections to vendor management and data integrity. His work has been extensively audited by regulatory agencies, study sponsors and hosting clients.

Mr. Develin received his MA and BA in Philosophy from Villanova University. He is currently completing his JD at Widener University School of Law.

Mr. Develin is an active member of the Health Law sections of both the American Bar Association and the Massachusetts Bar Association. He is also an Executive Board member of the Food and Drug Law Association (FDLA) at Widener University – working with the FDA and US Attorney's Office to conduct continuing legal education on FDA Enforcement issues.