Supplier Workshops
The FDA has already weighed in on the importance of adapting more rigorous supplier controls, and its emphasis on the link between supplier control and risk management will only continue to increase. To meet these elevated industry standards, manufacturers must implement an effective supplier acceptance approach with subsequent verification and preventive controls. This requires more than having an approved supplier list; it requires a dynamic process that manages how assessments, decision making and planning reduce or even eliminate risk in supply chain activities. MasterControl's supplier workshop will teach quality professionals the skills needed to evaluate their organization's compliance against the FDA's current purchasing control requirements, as well as how to implement effective controls for all of their supplied products and services.
MasterControl's Supplier Workshop Course Overview
Regulatory agencies have indicated that a more focused review of purchasing controls / supplier management processes will be enforced in all upcoming audits and inspections of life science companies and other regulated manufacturers. The MasterControl supplier workshop will teach quality professionals how to define, evaluate, document, and implement purchasing controls based on the most appropriate risk mitigation strategies for supplied products and services. Topics and course objectives include:
- Supplier Planning - Participants will understand the interaction of design and development, operations, and quality assurance by using a dynamic control planning (DCP) activity with a risk-based approach.
- Supplier Selection (Potential Suppliers) - Participants will learn how to perform non-exclusive selection and risk analysis on criteria-driven alternatives.
- Evaluation and Acceptance - Participants of the supplier workshop will build methods for supplier monitoring and metrics and also develop good effectiveness checks that meet GMP agreement components and trigger points for action.
- Finalization of Controls - Participants will learn the transition of methods for meeting acceptance requirements in configuration, acceptance criteria and supplier site validation activity (audits).
- Delivery Measurement and Monitoring - Participants will develop inspection management skills through control plan documentation, as well as how to incorporate quality event management with the initiation of a supplier corrective action preventive action (SCAPA).
- Feedback and Communication - Participants of the supplier workshop will develop covigilance activity and reporting formats for material change control, triggers for revalidation activity (re-audits), service reporting and more.
The MasterControl Supplier Workshop Helps You Eliminate These Common Supplier Management Issues
Any organization that obtains products or services from a supplier, contractor, or consultant is ultimately responsible for ensuring that all quality management and regulatory requirements are met. Outsourcing can increase an organization's operational and compliance risks - particularly if suppliers are not qualified or lack the appropriate level of control in their quality processes. The MasterControl supplier workshop, which are delivered on-site at the customer's facility, will provide quality professionals with the skills and tools necessary to eliminate the following supply chain issues:
- A subjective selection criteria with "gut feel" justification of approved suppliers
- A non-risk based approach entirely based on the impulsive need for a material or service
- Lack of prioritization due to subjective risk analysis
- No formidable path for evaluating a supplier in the proper context
- Lack of tangible metrics for control and evaluation
- Lack of good reconnaissance of a remote or distant supplier
The supplier workshop is taught using a blended approach of classroom and real-life application. This "how-to" approach significantly increases knowledge retention and allows participants to apply the skills as they learn in a dynamic setting. Click here to review the workshop agenda or to register.
Who Should Attend the MasterControl Supplier Workshop?
The course is appropriate for individuals who are regularly involved in establishing supplier agreements, supplier quality management, purchasing activities, and regulatory submissions for outsourced services and products.
The supplier workshop is one of five on-site quality management workshops offered by MasterControl to help quality professional gain the skills they need to stay current andcompliant in the workplace. Additional workshops are offered in audit, risk, document management, and CAPA. All workshops are delivered on-site at the customer's facility and can be customized to address specific industry compliance requirements. Class size is limited to 14 participants. Click on the links below for details on the additional workshops:
- Risk Workshop
- Audit Workshop
- CAPA Workshop
- Document Workshop
For More Information on MasterControl's Supplier Workshops
For more information about the supplier workshop, or any of our quality management workshops, contact the MasterControl Quality and Compliance Consulting Team or call 866.747.8767 today.
The QMS Provider for the FDA
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
Need more information?
To learn more about MasterControl's software systems, please contact a MasterControl representative.
