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
  1. Course Overview and Introductions
  2. Quality Management Systems
    1. What is Quality?
    2. US and International Quality System expectations
    3. Quality Assurance vs. Quality Control
  3. Applicability of Quality Systems to Clinical Research
    1. Clinical Quality Systems
    2. Sponsor Quality System responsibilities
    3. Clinical Investigator Quality System responsibilities
    4. IRB Quality System responsibilities
    5. Vendor Management and quality performance
  4. Building Quality From the Start: Developing the RFP
    1. Sourcing decisions (internal, external, new vendor)
      1. Vendor qualification/audits
      2. Vendor oversight considerations
    2. Defining the scope of your project
      1. Identifying the tasks vs ‘free consulting’ approach
      2. Internally defined requirements
      3. Vendor suggested activities
      4. Building consensus with internal team and potential vendors
      5. Sequencing the steps in the RFP development process
    3. Setting Quality Expectations
      1. Regulatory requirements
      2. Applicable guidance
      3. Protocol requirements
      4. Standard Operating Procedures as a quality standard
        1. Internal SOPs
        2. Vendor SOPs
        3. Project specific SOPs
      5. Monitoring Plans
      6. Data Management Plans
    4. Format of the RFP
      1. Overview of the Module based format
      2. Overview of the Activity Based Costing (ABC)Format
      3. Pros and Cons of each format
  5. Interactive Group Activity: Develop Draft RFP

  1. Managing the RFP Process
    1. Setting deadlines
    2. Answering questions
    3. Revising the RFP
    4. Evaluating vendor interactions during their proposal development
  2. Evaluating and Comparing RFPs
    1. Factors to consider other than cost
    2. Evaluating vendor interactions during their proposal development
    3. Missed deadlines
    4. Nonconforming responses
    5. Evaluating large differences in cost estimates
    6. Eliminating candidates/narrowing the field
    7. Interactive Group Activity: Evaluating RFPs
  3. RFP Revisions
    1. When should you revise an RFP and request updated bids?
    2. Who will be invited to revise?
    3. Can you proceed without a revision?
  4. Concluding the RFP Process
    1. Notifying rejected vendors
      1. Respect and professional replies
      2. How much information are you willing/able to share about why not selected?
      3. Is there still a potential for future opportunities? If not, why not?
    2. Notifying the successful vendor
      1. How much information are you willing/able to share about why they were selected
      2. Linking contracts to the RFP
  5. Quality Management Comes Full Circle:
    1. Review of key take aways and wrap up

Meet Your Instructor

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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