Description :
This training on qualification and control of suppliers and contractors in the medical devices and pharmaceutical industry will review compliance requirements, the qualification cycle, the key steps involved in it, including the audit process, use of audit tools and evaluation to decide on qualification/ disqualification...
Why Should You Attend:
This course reviews the qualification cycle for suppliers and contractors. Although the process is similar, the contractor requires more scrutiny because contractors are subject to GMPs.
The qualification cycle begins with the material specification and ends with process validation. The key steps between the beginning and the end will be discussed in the webinar. They include supplier/contractor selection, research, the questionnaire, the audit, evaluating the audit and following the preset criteria for qualification, report preparation, negotiating corrective actions, mutual approval of the specification, change control agreement, monitoring the supplier/contractor quality, verifying acceptance by certificate of analysis, corrective action follow-up, and re-audit for qualification based on supplier history.
The use of some auditing tools will be explained. Questionnaires for all types of suppliers and contractors developed by the presenter will be shown and described. Examples include Medical Device, Pharmaceutical, Active Pharmaceutical Ingredient, Contract Laboratory (GMP), Contract Laboratory (GLP), Equipment Manufacturers, and Calibration Providers. Supplier/Contractor Research guides will also be shown. Other tools presented during the course include audit flow sheets that are specific to the type of audit being conducted. Examples of these include Parenteral, API, USP, water production and laboratory.
Learning objectives:
- The Lack of Material Controls Causes Problems but Teamwork Overcomes It.
- The Component Specification & Associated Analytical Methods Is the Battleground.
- You Must Know More About the Supplier Quality System Than They-Be Prepared.
- Audit Tools helps To Guide the Qualification Decision.
- One of Your Roles is to Reduce Risk to Your Company.
- The Qualification Decision Will Never Be Forgotten.
- Follow-Up Activities Are More Important Than the Audit Report.
- Now, I Think I Understand What the FDA term, Supplier History, means.
Areas Covered in the Seminar:(All time in EDT)
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11:00 – 11:10
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Introduction & Overview
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11:10 – 11:25
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Quality 101
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11:25 – 11:45
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Compliance Requirements for Materials and Suppliers
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| 11:45 – 12:00 |
The Dynamic Environment of Suppliers & Contractors
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| 12:00 – 12:10 |
The Specification for the Component/Ingredient
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| 12:10 – 12:20 |
The Role of Quality Control Laboratory
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| 12:20 – 12:40 |
Laboratory & Material Qualification
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| 12:40 – 12:50 |
Q&A 1
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| 12:50 – 1:20 |
Break 1
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| 1:20 – 1:30 |
Researching Suppliers And Contractors
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1:30 – 1:40
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The Questionnaire-An Under Rated Assessment Tool
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1:40 – 1:50
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The Audit Team.
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1:50 – 2:00
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Planning the Audit
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2:00 – 2:15
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Conducting the Audit
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| 2:15 – 2:25 |
Evaluating the Results and the Qualification Decision
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| 2:25 – 2:35 |
Writing the Report And Presenting It to the Auditee
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| 2:35 – 2:45 |
Q&A 2
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2:45 – 3:15
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Break 2
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3:15 – 3:20
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Material Validation
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3:20 – 3:35
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Corrective Action and Supplier Monitoring & Database
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3:35 – 3:40
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Supplier Quality Metrics
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3:40 – 3:50
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Summary
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3:50 – 4:00
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Final Q&A
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Handouts:
PDFs of the following will be provided
- Diagrams explaining the subject matter
- Process Diagrams
- Examples of Questionnaires
- Audit Flow Diagrams
Who Will Benefit:
- Quality Management, Supervision, Leads, And External Quality Auditors
- Quality Control Laboratories-Supervision and Management
- In Coming Material Testing Quality Control Laboratories
- Incoming Warehouse
- Purchasing, Warehousing, Production, Finance(Material Cost Accounting)
- Regulatory Affairs
Speaker: Howard Cooper, Consultant, EQACT Inc
Howard Cooper, has over 40 years experience in the pharmaceutical and medical device industry creating, implementing, managing & remediating quality systems. This experience has shown his leadership, organizing & problem-solving skills to develop quality systems from scratch or in the role of a change agent to remediate failing systems. This experience includes small and large companies operating in the US, Europe and Japan. He has worked with a wide variety of FDA regulated products such as medical devices, in vitro diagnostic reagents and instruments, in vivo diagnostics, pharmaceuticals (Tablets, capsules, injectables), biologicals, monoclonal antibodies), and combination products.
He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.
During experience described above, Mr. Cooper has implemented full supplier qualification systems and programs. This includes both consulting and employee roles.
To register/enquire, please contact:
www.compliance.world
Call us at this Toll Free number: +1-866-978-0800
