Outsourcing Management - Effective Contract Manufacturers, Supplier Evaluation, Approval and Monitoring
Overview:
Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing the GMP mandates and it is the firm's responsibility to make sure vendors/suppliers are meeting 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 but, in many cases.
These were not being implemented effectively or formally documented. Making these programs part of a risk-based quality systems approach that the FDA and other regulatory agencies have come to expect from industry is critical. The course will include a process for selection, evaluation, audit, approval and monitoring 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.
This course will discuss the regulatory expectations and other industrial references/standards that will impact your system. Then, we will discuss the general requirements of a vendor/supplier (outsourcing management) control program followed by specific requirements for different types of supplied materials/equipment/services and the application of a risk-based categorization system. The importance of the audits and the final contract/quality agreement will be included.
Why should you attend: Recently, the FDA is focusing aggressively on these areas based on particular events including the Heparin case from 2008. Another factor is the globalization of our industry when more than 80% of our API's come from outside the US and most of our materials as well. There is a need for an effective plan, risk assessments and adequate resources to deal with outsourcing controls.
Areas Covered in the Session:
- Regulatory Background and Industry References and Standards
- Fundamentals of an Outsourcing Management System
- Procedure and Documentation
- Pre-requisites - specifications and internal agreements
- Selection of vendors/suppliers/service providers
- Audits - a risk-based approach to determine the requirements and levels of the assessments
- Approval of supplier/vendors - Quality Agreement/Contracts
- Maintenance of the program
- Impact of the Quality Agreement/Contract
- Practical aspects of an Outsourcing Management Systems for Materials and Components
- Specifics related to equipment/system suppliers
- Specifics related to Contract Services - Manufacturing, Packaging, Calibrations, Laboratories, Equipment/System Maintenance
- Monitoring of the Approved Contractors/Suppliers and Management of Change within the Outsourcing Management System
Who Will Benefit:
- Purchasing
- Materials Management
- Development
- Quality
- Manufacturing
- Engineering
- Top Management