Pharmaceutical and Medical Device Good Manufacturing Practices Similarities and Differences
Date & Time: Wednesday, November 23, 2011
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Howard Cooper
Price : $245.00
(for one participant)
Howard Cooper President, EQACT, Inc.
This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents.
Areas Covered in the Session:
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Module 1 - Introduction to Quality and Compliance Concepts Module 2 - Differences between Medical Devices and Pharmaceuticals Module 3 - Scope of the GMPs and the Quality Cycle Module 4 - Standards of Quality Module 5 - The Shifting Paradigm to Focus on Customer and User Satisfaction- The Quality Systems Approach Module 6 - A Comparison of Definitions and Terms Module 7 - Comparison of Personnel and Management Expectations Module 8 - Comparing Design Requirements Module 9 - Comparing Master Records Module 10 - Comparing Equipment Controls Module Module Module Module Module Module Module Module Module
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Comparing Material and Incoming Controls Comparing the Control of Processes Packaging and Labeling Comparisons Laboratory Controls and Device Evaluation Holding, Distribution, & Returns Problem Solving-Deviations, Complaints, and CAPA How about Part 11 Current Trends Review and Wrap-up
Click here to register for this webinar Who Will Benefit: l
Quality, quality control, regulatory affairs, operations working in the FDA regulated medical products industry (Pharma & Device) in the design, scale-up, regulatory approval, commercialization, and maintenance of quality systems.
Suppliers providing materials and contractors supplying outsourcing s services to FDA regulated clients. Companies working with Combination Products and him
Howard enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. 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. ...more
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