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Quality Agreements for Clinical Vendors and Service Providers
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To be as brave as the people we help
1
exl Quality Oversight ofClinical Vendors
Conference
Operationalizing the Quality Agreement
Stan Szpindor, M.S.Director, R&D Quality Operations
To be as brave as the people we help
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Areas to be Covered
Basis for a Quality Agreement (QAG) and use in the GCP Setting
Practical Considerations for Content
Operationalizing the Quality Agreement
Use During Inspections
To be as brave as the people we help
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QAG Basis
THE QUESTION:
Is The Use Of A Quality Agreement Suitable For The
GCP Environment?
To be as brave as the people we help
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QAG Fundamentals
Common Terms: Quality Agreement, Technical Agreement, Master Quality Agreement
Definition:
Legal: An Expression of Assent by two or More Parties to the Same Conditions
QAG: An Arrangement Between Two or More Parties Engaged in a Business Relationship Pertaining to the Quality Responsibilities of Each
Goal: To Establish Expectations
Not One Sided
To be as brave as the people we help
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QAG Fundamentals
Background:
U.S.: Expectations for use have developed from interpretation of cGMP regulations
21 CFR 211.22(a) pertains to the quality control unit and makes reference to contracting out these tasks
QAGs have been used in cGMP arena for many years
EU: Required under Directives 2003/94/EC and 91/412/EEC
EU GMP Guide further defines “contract giver” and “contract acceptor”
More commonly referred to as Technical Agreement
To be as brave as the people we help
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Elements of the QAG
Parties and Recitals
Legal Entities being Bound by Agreement
Type of Businesses and References to Master Service Agreement
Interpretations
Notes terms of QAG Intended to Supplement and not Conflict with MSA
Prevailing Agreement
Scope
Overarching and Relationship Based
May reference a specific Product
Can be limited to only one or two Services
To be as brave as the people we help
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Elements of the QAG
Definitions
Ensure Consistency and Common Ground
Miscellaneous
Term: separate or tied to MSA
Confidentiality Reinforcement
Key Contacts and Notices (QA, Legal)
Conflict Resolution
Content
Content Goal: “Bridge the Gaps”
Transparency and Cooperation
Relationship Governance Board
To be as brave as the people we help
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Content Considerations
cGMP
1. Product Specifications
2. Quality Control Testing
3. Complaint Handling
4. Record Keeping and Reports
5. Batch Production Controls
6. Process Validation
7. Equipment Cleaning
8. Change Control
9. In-process Testing
10. Deviations & Investigations
11. Product Recall
12. Shipping Process
13. Packaging & Labeling
14. Audits & Inspections
GCP
1. Quality & Quality Assurance
2. Standard Operating Procedures
3. Regulatory Inspections
4. Scientific Misconduct
5. Functional Plans
6. Investigational Product Complaints
7. Subject Confidentiality/HIPAA
8. Lessens Learned
9. Access to Original Source Documents
10. Use of Electronic Systems
11. Protocol Violations
12. Qualified Personnel
13. Subcontracting
14. Relationship Governance
To be as brave as the people we help
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To be as brave as the people we help
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Content Considerations Cont.
Audit Conduct (Routine & For-Cause) • Types of Audits: Site, Service Provider, TMF, Data, PV, CSV
• Notification Process / Lead Time• Personnel: Sponsor, Independent, Competitor
Audit Report Facilitation & Access
• QA to QA Distribution of Audit Reports• Cycle time to Secure CAPAs• Time Extensions, Return for More Information• Access to Provider Audit Reports for Project Specific and Process
Regulatory Inspections • Notification & Timeframe for Notice• Rights for Preparation and Onsite Support• Permissions for Making Commitments & Response Review
Scientific Misconduct• Notification, Investigation, Serious Breach Reporting, Site Closure
Electronic Systems • Expectations for SDLC, Validation, Part 11 Compliance, Documentation• Investigator-based: Direct Access, Testing, Documentation
To be as brave as the people we help
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To be as brave as the people we help
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Content Considerations Cont.
Subject Confidentiality• Applicability of Regulation: HIPAA, EU Data Protection• Safeguard of subject data to EU Directive 95/46 EC
Quality Control• Process for Documented Review of Deliverables• Current Procedures• Access for Periodic Review•Sponsor lead Functional Assessments
Archive • Storage Timeframes Onsite, Offsite, and Costs• Fulfillment Times During Inspections• Transfer to Sponsor
Qualified Personnel• Minimum Experience Requirements & CV/Job Description Req.
Protocol Violations • Expectations for Documenting, Reporting, Tracking• Waiver Position
To be as brave as the people we help
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Operationalizing the QAG
When Will You Use?
Strategic Partners, Global Providers, Niche Vendors
Volume of Studies, $$ Spend, Importance of the Studies
How: Standalone vs. Part of Service Agreement
Standalone if Agreement Already in Place, Expected Delays in Negotiating the Service Agreement, Legal Review a Nightmare
Appendix to Agreement if New Relationship, Will have Greater Enforceability, More Difficult to Update
To be as brave as the people we help
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Operationalizing the QAG Cont.
What Format?
Tabular: Ease of Review, Clear Delineation of Responsibility
Legal Style: TOC, Intro., Recitals, Disclaimer Pages
Hybrid
How to Negotiate?
Quality Agreement Does Not = QA Exclusivity
Identify Internal Stakeholders Empowered
Ask the Domain Question
Small Cross-Functional Team at Table or QA-to-QA
To be as brave as the people we help
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Operationalizing the QAG Cont.
Legal Review?
Absolutely if Part of Overall Agreement
Maybe Not if Standalone
Legal Approval of Template with Highlighted Fields
Items to be Left Out: Force Majeure, Payment Terms, Arbitration, Terminations, Settlements
Maintenance?
Predetermined based on Set Date
Periodic Review
Transferable & Assumable
To be as brave as the people we help
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Use During Inspections
How Do You Demonstrate Delegation of Key Roles and Responsibilities?
MSA with Statement of Work?
Delegation of Responsibilities Matrix?
Quality Agreement
Regulators Want to Know About Oversight and How the Parties have Assigned Responsibility
To be as brave as the people we help
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Defining the Business Relationship
Ongoing Dialogue and Negotiation = Success
Recommend Face-to-Face for Initial Iteration
Stay Grounded in Reality
Anticipate Problems and Acknowledge Upfront
Plan for Resolution Before Occurrence
Choose Wisely
Best QAG Cannot Make up for Poor Business Decision
If Study Doesn’t Match the Provider’s Capabilities, Project Will Fail and All Parties Will Suffer
To be as brave as the people we help
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QUESTIONS