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.
For many years, 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. The 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.
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.
In conclusion, participants will learn the maintenance aspects of such a program including handling of non-conformances, and timing and nature of additional audits. 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, Development, R&D, 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.
Upon completion of this course, attendees will:
- Understand requirements from regulatory agencies and other organizations in relation to supplier and vendor approvals and qualifications, including procedural and documentation needs. This will include an understanding which types of vendors are under regulatory agency control and which are not
- Be able to develop adequate procedural and documentation controls for the selection, approval and qualification (certification) of vendors and suppliers. This includes the development of an audit program designed with different levels of formality depending on the criticality (risk-based) of the material/component/service being provided
- Understand that controls are not limited to materials and components but also apply to contract service providers such as CROs, calibrations, laboratories, maintenance, contract manufacturing/packaging and others, including software vendors and data hosting providers
- Be able to develop a quality agreement/contract with your suppliers/vendors that will define responsibilities and have adequate controls and documentation to maintain a business relationship based on trust and communication
- Be able to proactively protect the quality of your products and effectively handle any deviations and non-conformities
The course will use interactive workshops and discussions to enable delegates to exchange ideas and experiences while also learning from each other’s experiences.