Wilmington , DE (PressExposure) June 03, 2011 -- Overview: This webinar will demonstrate how to implement an effective audit program. 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 these 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. However, in many cases these protocols 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. This webinar will discuss how to implement a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered.
We will also 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.
Areas Covered in the Session:
- The components of a Supplier/Vendor Qualification/Audit program.
- The Regulatory requirements and other standards in relation to suppliers and vendor approvals and qualifications, including procedure and documentation needs
- Implementing a Supplier/Vendor Qualification/Audit program designed with different levels of formality depending on the criticality (risk based) of the material/component/service being provided
- Performing the audit(s).
- Documentation associated with the audit(s).
- Supplier/Vendor disqualification.
- Regulatory expectations; recent FDA inspectional observations & how to avoid common pitfalls.
Who Will Benefit: The course will be valuable for those in pharmaceutical, biotechnology and medical device manufacturing who are responsible for, or involved in, supplier/vendor management, qualification, procurement or maintenance. Development, R&D, Validation and QA/QC personnel will also benefit as the course details all the steps necessary to carefully document the process of vendor selection while working within the confines of a risk-based audit system
Live : $245.00
Corporate live : $995.00
Recorded : $295.00