Course Description:
Learn how to make the most of your team’s time by ensuring that the RFP process will produce results that enable comparison of vendors. Recognize the value of investing time up front in developing a robust RFP to not only foster comparisons, but to support the communication of your quality expectations from the proposal process through the evaluation of deliverables during project completion.
Although the Quality Management System concept originated in the Medical Device Regulations, specifically 21 CFR Part 820, the concept are becoming widely recognized as an appropriate standard for conduct of all clinical research. Since vendor oversight is an important sponsor obligation, regardless of the product being developed, laying the foundation for quality should begin during the vendor selection process.
The process begins by selecting the right vendor for the right reasons which can be a very complicated undertaking if you don't know how to approach it from the very start. You will need to assess your business requirements, identify prospective vendors, lead your team in selecting the winning vendor and successfully negotiate a contract.
The Request for Proposal process is time consuming for both the purchaser and potential suppliers. You will need to be able to compare bids to select the best qualified vendors for your projects. Unless you clearly state your requirements you can end up unable to make an ‘apples to apples’ comparison and you may also select a substandard vendor.
If you are looking for answer of these questions, you would certainly benefit by attending this seminar:
- Do your RFPs detail expected performance parameters?
- Have you clearly defined your quality expectations?
- If you haven’t defined the tasks and performance standards, how do you know that your vendors will be able to meet your requirements?
Learning Objectives:
Key goals of the conference will include learning:
- Critical Content to include in your RFP
- How to build internal team and vendor consensus on RFP requirements
- Identifying Key Quality Performance Objectives
- The advantages and shortcomings of 2 different RFP models
- The importance of pre-award interactions with potential vendors
- Contractual considerations for quality performance based upon RFP responses
Who will Benefit:
Medical Device and drug firm senior executives, directors, managers and those who have responsibility for outsourcing and vendor selection, including officials from these areas within regulated companies:
- Clinical Operations
- Project Managers
- Vendor Management
- Quality and Compliance
Course Outline:
| Day One: 8:00 AM - 4:00 PM | Day Two: 8:00 AM - 1:00 PM | ||
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Meet Your Instructor
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Glenda Guest Vice President of Norwich Clinical Research Associates Ltd Glenda Guest is Vice President of Norwich Clinical Research Associates Ltd. (NCRA), a full service Clinical Contract Research Organization (CRO) serving the pharmaceutical, medical device, biologics and nutritional product industries since 1994. She specializes in medical device monitoring and project management, auditing and training on US regulated research, quality systems and Good Clinical Practices in clinical research settings as well as for professional organizations. Her auditing experience includes GCP auditing, independent third party, pre-PMA audits, Japanese GCP preparation audits and includes corrective action recommendations. She provides SOP development assistance and staff training relative to correcting audit deficiencies. Ms. Guest has maintained her status as a Registered Quality Assurance Auditor - Good Clinical Practices (RQAP-GCP) through the Society of Quality Assurance since 1997. She is a published writer, trainer and invited speaker at local and global professional meetings. |
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