Cheryl McCarthy Manager, Quality Assurance MBC Session October 3, 2008 GCP Compliance in our Vendors

2 CMcCarthy – MBC 2008 Objectives  Understand how to assess:  GCP Requirements for Clinical Trials  Vendor Compliance

3 CMcCarthy – MBC 2008 GCP Definition of Good Clinical Practice –A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. (ICH E6)

4 CMcCarthy – MBC 2008 GCP

5 CMcCarthy – MBC 2008 Vendors and GCP Vendor Types & General Audit Considerations

6 CMcCarthy – MBC 2008 Vendors and GCP Types of entities to be audited:  CRO’s  Software Suppliers  Specialty Vendors

7 CMcCarthy – MBC 2008 Vendors and GCP Purpose of audit: To ensure that XYZ Company has the appropriate processes, procedures, supporting documentation and qualified personnel to provide quality and compliant services.

8 CMcCarthy – MBC 2008 Vendors and GCP Activities Understanding Documents Interviews Training

9 CMcCarthy – MBC 2008 Vendors and GCP Audit Standards:  21 CFR Part 11 FDA Guidance: Computerized Systems Used In Clinical Investigations (05/2007) Polices, Procedures, and Processes Policies, Procedures, and Processes

10 CMcCarthy – MBC 2008 Vendors and GCP Common items to audit regardless of type:  Org Chart  Is QA a role within the company?  Is QA independent?  Do they have appropriate management and staff levels to support your business needs?

11 CMcCarthy – MBC 2008 Vendors and GCP Common items to audit regardless of type:  Locations  Where will the work be performed?  Do you need to audit more than one location?  Off-shore component?

12 CMcCarthy – MBC 2008 Vendors and GCP Common items to audit regardless of type:  Documents  Quality Policy/Manual/Procedure  SOP on SOPs  Training Records and Requirements  CVs – current ones outlining their vendor role  Job Descriptions

13 CMcCarthy – MBC 2008 Vendors and GCP Common items to consider regardless of type:  Audit Team  QA Only  QA + Subject Matter Experts (IT, DM, etc…)  How Often  Preferred Provider List  Dictated by company SOP

14 CMcCarthy – MBC 2008 Vendors and GCP Common items to consider regardless of type:  Disaster Recovery/Business Continuity

15 CMcCarthy – MBC 2008 Vendors and GCP Audit Scenarios

16 CMcCarthy – MBC 2008 Vendors and GCP Scenario #1: CRO Audit Items to consider:  What services are being outsourced?  Whose SOPs are being followed?  Trial Master File Considerations?

17 CMcCarthy – MBC 2008 Vendors and GCP Scenario #2: Software Vendor Audit Items to consider:  Hosted or Technology Transfer?  Validation Documentation?  Training on the system for staff/users?

18 CMcCarthy – MBC 2008 Vendors and GCP Scenario #3: Specialty Vendor Audit Items to consider:  What type of role do they have for your company – risk assessment?  Chain of Command  Equipment Use and Maintenance  Computer Platforms – integration of systems

19 CMcCarthy – MBC 2008 Vendors and GCP Performing the Audit

20 CMcCarthy – MBC 2008 Interviews How to assess GCP compliance during an interview?

21 CMcCarthy – MBC 2008 Interviews Describe the process for…

22 CMcCarthy – MBC 2008 Interviews What regulations apply to your role?

23 CMcCarthy – MBC 2008 Interviews How are you trained on… ?

24 CMcCarthy – MBC 2008 Interviews Where is the documentation for … filed?

25 CMcCarthy – MBC 2008 Personnel Qualifications Qualified Personnel CV vs. Job Description Trained Personnel Continuing Education

26 CMcCarthy – MBC 2008 Report Findings and Observations If it wasn’t documented, it didn’t happen… Compliance with Regulatory Requirements Process and Procedure Qualified and Trained Personnel Good documentation practice

27 CMcCarthy – MBC 2008 Objectives  Understand how to assess:  GCP Requirements for Clinical Trials  Vendor Compliance

Cheryl McCarthy Manager, Quality Assurance MBC Session October 3, 2008 GCP Compliance in our Vendors