Quality Control and Quality Assurance, Is there really a difference?
•Als PPTX, PDF herunterladen•
6 gefällt mir•728 views
This is a slide deck that starts to help those in the pharmaceutical research industry begin to understand the key differences between QC and QA. The presentation also delineates the different levels of QC and the types of QA audits. The presentation also touches on the do's and don't's of conduct during a FDA audit,
Empfohlen
Weitere ähnliche Inhalte
Was ist angesagt?
Was ist angesagt? (20)
Andere mochten auch
Andere mochten auch (20)
Ähnlich wie Quality Control and Quality Assurance, Is there really a difference?
Ähnlich wie Quality Control and Quality Assurance, Is there really a difference? (20)
Kürzlich hochgeladen
Kürzlich hochgeladen (20)
Quality Control and Quality Assurance, Is there really a difference?
- 1. Quality Control and Quality Assurance Is There Really a Difference?? 1
- 2. Twenty years of industry experience Clinical RN to Chief Operating Officer Patrick R. Ayd MBA, BSN, RN President/CEO/Lead Auditor of ClinPharm Network, Inc. 2 GCP audits & manage Site QA programs
- 3. Workshop Goal Identify the foundational “Building Blocks” essential to the development of a Quality Clinical Trial Site 3
- 4. 4 Gain an increased perspective on FDA expectations during and after an audit Clarify the differences between Quality Control (QC) and Quality Assurance (QA) Comprehend the importance of Standard Operating Procedures(SOP) in QC and QA Conduct quality control review on actual source documents Workshop Objectives 1 2 3 4 5 Receive a valid quality control (QC) SOP template
- 5. Why is a “Quality” Organization Critical? Business Development PI is Solely Responsible Data Acceptability 5
- 6. Quality Control Definition Verifying and maintaining a desired level of quality in an existing product or service by careful planning, use of proper tools, continued inspection, and corrective action as required 6
- 7. Quality Assurance Definition A system for ensuring a desired level of quality in the development, production, or delivery of products and services with continued inspection, and corrective action as required 7
- 8. Quality Control vs. Quality Assurance QC Verifying and maintaining a desired level of quality in An Existing Product or Service QA System for ensuring A Desired Level Of Quality in the development, production, or delivery of products or services 8
- 9. Key to Good Quality Control Formal, Well Documented Process Documentation of QC Performed Ink Stamp Procedure Involve Staff In Process Quality Control 9
- 10. Varying Degrees of Quality Control (W)Hole Checking Consistent Data Believable Data 10
- 11. Building Blocks of a QC SOP 11
- 12. Quality Control Standard Operating Procedure 12 Define WHO will conduct the QC process Define WHEN the QC process will be completed What documents will be QC’d 100% of the time The % of other documents that will be QC’d Do not alter/modify sponsor provided or sites’ source documents Precisely describe the documentation process Use the lower right reverse side method Use “unusual” ink color for stamp Flag documents that have problems Do not stamp documents until complete problem resolution
- 13. Breakout Session 13 Review of Source Documentation Documentation of Quality Control
- 14. 30-45 Minutes 14
- 15. Quality Assurance Definition A system for ensuring a desired level of quality in the development, production, or delivery of products and services with continued inspection, and corrective action as required 15
- 16. QA Function needs to be Truly Independent of Clinical Function
- 17. Foundation of a “Quality” Organization SOPs and Training Program Performance Evaluation System ++ Job Descriptions 17
- 18. Types of Quality Assurance Audits Trial Specific Audit Facility GCP Audit In Process Audit Vendor Audit~ 18
- 19. Trial Specific Audit High Enroller Out of your typical therapeutic area Poor monitoring Poor results from internal review~ 19
- 20. Overall Facility GCP Audit Clinical Equipment Monitoring Sample Handling Informed Consent Process Training and Training Documentation Provision of Emergency Care Investigational Product (IP)/Drug Accountability PI Involvement Screening Recruitment Data Collection 20
- 21. In Process Audit Observe: Screening Visit Conduct of Informed Consent Process Investigational Product (IP)/Drug Dispensing Adverse Event (AE) Assessment 21
- 22. Vendor Audit Pharmacy Provider Long term Storage Facility Local Laboratory Local IRB~ 22
- 24. Documentation of a Quality Assurance Program Binder that keeps all information in one place Protected QA Documents Audit Reports CAPA Plans Audit Certificates Reviewer of all SOPs 24
- 25. Perspective on an FDA Audit During an Audit Organized regulatory binders Organized patient charts Organizational chart Training records After an Audit No more “Further Avoidance of Same” Don’t throw anyone under the bus Vague terms of changes made or improvements Quality Assurance/ Improvement program in place 25
Hinweis der Redaktion
- Click to add text Industry experience spanning 20 years Have held positions from clinical RN to COO President/CEO/Lead Auditor of ClinPharm Network, Inc. Conduct site audits and manage independent Quality Assurance programs
- “Take Away”-Solid Quality Control SOP
- NO need to click for text to appear “Take Away”-Solid Quality Control SOP template
- Click to add text For the obvious reasons Any Site Owners or PIs in the room?? The PI has to have the confidence that all delegated tasks are being performed as s/he wants them performed
- Verifying And Maintaining A Desired Level Of Quality In An Existing Product Or Service by Careful Planning, Use Of Proper Tools, Continued Inspection, and Corrective Action as Required System For Ensuring A Desired Level Of Quality In The Development, Production, Or Delivery Of Products & Services With Continued Inspection,& Corrective Action as Required
- Click to add text Formal, Well Documented Process (SOP) Documentation of QC Performed Involve Entire Staff in Process Description of Ink Stamp Procedure-Lower right reverse side method We’ll discuss further in a bit when we discuss the Quality Control SOP
- Click to add text This is where team work becomes critical Whole checking: Is the document whole? Are there any holes that need to be completed i.e. signatures, initials, data, etc. Believable Data: Does the data make sense i.e. BP 80/120, HR 312, LMP data in a male chart Consistent Data: Is the data consistent, BP at last visit 102/60, now 140/88, HR changes, no middle initial used prior, now present, etc.
- In order to check if certain processes were done correctly you need to have a solid base of SOPs, which includes of course an SOP on the Quality Control process.
- Your SOP needs to define WHO will conduct the QC process WHEN the QC process will be done (can be different by document, i.e. ICF) WHAT documents will be QC’d 100% i.e. ICFs WHAT % of standard documents will be QC’d HOW the QC process will be documented
- Quality Assurance looks at larger processes versus individual completed documents. Is there a system or tools in place to ensure quality?
- Report Directly to CEO or Medical Director-based on organizations size and structure The Quality Assurance person can’t be constantly worried about job stability because of reporting problems or performance issues For most organizations the answer is to outsource the Quality Assurance function, it’s cheaper and much more effective
- Though only 3 blocks, there are 6 basic tenants of a quality organization separate pieces—add Quality Control and Quality Assurance programs These are must haves in order to run an efficient Quality Assurance program internally or externally Job Description: Lets the employee know what procedures/tasks they are responsible for SOPs: Shows employees how the procedures/tasks are performed at our trial site Training: Train the employees on a regular basis how to perform the procedures/tasks they are responsible for Performance Evaluation: Lets the employee know how they are performing to the standards that have been set (yes this is a pain) WITHOUT ALL 4 IT IS DIFFICULT TO CREATE AND IMPLEMENT A CAPA WHEN ISSUES IDENTIFIED BE IT INTERNALLY OR EXTERNALLY IDENTIFIED.
- Don’t explain specifics, slides to follow
- Click to start text
- Just to list a few, there are many more
- Click to start text This is just a list of examples. Can you think of any others??
- Click to start text
- Click to add Critical Link text after change and training
- I have been through 11 FDA audits and have helped “clean up” after another 5. Spend the money necessary to purchase good binders and section dividers Don’t rush to recycle binders and section dividers If a 483 is issued and you respond, Nothing worse than “your response was unacceptable, no further response required”.