3-hr Virtual Seminar: Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)
Duration: 180 Minutes
While there is very little disagreement about the importance of controlling suppliers and contractors, quality problems and compliance issues attributed to supplier/contractor failures continue to be very problematic in our industry.
Some reasons this problem exists include lack of understanding of the process and its requirements, fragmented procedures that do not consider the logic and flow of the processes as a whole, the failure to understand the interdepartmental tasks and responsibilities, and the failure to communicate the requirements to the supplier or contractor. These failures are frequently seen in FDA 43 citations and warning letters. Senior Management can see the impact on profit and customer satisfaction.
The FDA continues to place a high priority on quality failures attributed to supplier/contractor failures caused by supplier/contractor provided components and products. The root cause is a failure of the company to control the supplier and contractor. In May 2013, the FDA published the quality agreement guidance on the requirements for quality agreements. While this may clarify some compliance issues, more understanding of quality systems is required to sufficiently address these issues.
- Introduction, Purpose, and Objectives
- Basic Regulatory and ICH/IMDRF (Was GHTF) Requirements for Suppliers and Contractors
Moving Beyond the Basics-Add Your Company’s Requirements Plus
- Defining common terminology found in FDA regulations and ICH & GHTF documents
- Comparing regulatory and guidance citations for pharmaceuticals and medical devices
- FDA Guidance 5/24/2013-Contract Manufacturing Arrangements for Drugs: Quality Agreements
- Current Industry Practice
Organizing and Establishing the Supplier/Contractor Qualification and Control Program
- Answer This Question-Are you satisfied with minimum requirements?
- Establishing your company’s policies and procedures
- Your company’s criteria established for approval or rejection of suppliers
- Other regulatory requirements such as DEA, NRC, EPA, & OSHA
- The virtual company that outsources all manufacturing and testing
A flowchart with the entire process for selecting, auditing, and qualifying suppliers and contractors will be discussed. Some of the processes included are:
- Senior Management must assure that an inter-functional team, consisting of quality and other impacted functions, is established with defined roles and responsibilities
- Requirements and objectives should be established in a corporate policy
- Procedures must be developed describing the entire process for qualifying a supplier describing the flow of activities, the inputs and outputs, and responsibilities for each function...
- A virtual company requires special considerations and procedural modifications
The Changing Supplier/Contractor Paradigm and the Future
Why Should you Attend:
- Identifying suppliers, initial research, and qualifying their samples/prototypes
- Audit preparation-selecting audit team, preparing the agenda, & other preparation
- Conduct audit including the opening and closing meetings
- Evaluating the audit data to determine qualification status
- Preparing the audit report and the corrective action requirements
- Sending the report and evaluating the supplier/contractor response
- Follow-Up, monitoring, and determining audit frequency
- Qualifying for reduced testing
- Supplier disqualification
Whatever your experience level is, this webinar will help you understand the entire lifecycle of suppliers and contractors. They gaining an understanding of the processes, you can compare your processes to the processes described in this webinar. You’ll see the strengths and weaknesses of your own processes so that you may build on the strengths and improve the weaknesses. The result will be a more effective operation.
Objectives of the Presentation:
Who can Benefit:
- To clearly define the regulatory requirements for incoming material controls and suppliers/contractors
- To introduce quality concepts and principles outside the regulations that improves supplier/contractor control and effectiveness
- To provide a perspective on the FDA guidance "Contract Manufacturing Arrangements for Drugs: Quality Agreements", May-2013
- To enhance the understanding of the supplier-contractor lifecycle by using flowcharts describing the logical inputs and outputs of the process
- To describe the "What & How" for establishing a program for effectively controlling suppliers and contractors
Live Session - How it works
- Material Laboratory Managers & Personnel
- Incoming Warehouse
- Purchasing & Production
- Quality Assurance Managers
Recorded Session - How it works
- We will send Username and password 24 hours prior to webinar at your email address.
- Webinar presentation handouts will be shared in pdf format, a day before live presentation.
- Use the login details to participate in sessions.
- Clear out your queries through interactive Q&A chat boxes with the speaker.
- We need to know your experience, so please don't skip to provide us with your overall presentation feedback.
- Get certification of attendance.
- Once you purchase a webinar you will receive username and password at your email address.
- Use the login details to view recorded webinars.
- Presentation handouts will also be shared in pdf format.
- Access to the recording is valid only till 6 months starting from the date of purchase.
- Get certification of attendance.