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Hybrid Quality Systems For Pharmaceuticals - Combining ICH Q7A & Part 210-211
Date & Time:
Thursday, September 29, 2011 10:00 AM PDT | 01:00 PM EDT

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Duration: 90 Minutes Location: Online

Instructor: Howard Cooper Price : $245.00

(for one participant)

Instructor Profile:

Overview:
The manufacture of drugs is controlled by ICH-Q7A and 21 CFR Part 210 & 211. Although these standards were written 24 years apart, they complement each other in many ways. 21 FR Part 210 & 211, written primarily by scientists, is very structured and detailed. On the other hand, ICH Q7A authored by participants from industry and regulatory bodies emphasizes modern Quality Assurance practices. ICH Q7A clarifies some quality practices such as senior management responsibilities, change control, and validation that have been categorized as "industry practice" in Part 210 /211 but are included as expected requirements in ICH- Q7A. It reflects.

David R. Dills Industry Regulatory & Compliance Consultant, 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

Why Should You Attend:

The purpose of this webinar is to show how to create a "hybrid" quality system that combines Part 210 & 211 requirements with ICHQ7A requirements. Each of us has our own philosophy of quality and compliance and it should be noted both are very important.

Areas Covered in the Session:

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Quality 101 Jurans's Quality Loop And Its Application T o Our Industry The Scope of the GMP's. Comparison of Part 210/211 & ICH-Q7A Praises and Accomplishments of Part 210/211 & ICH-Q7A Constructive Criticism of Part 210/211 & ICH-Q7A The FDA Quality Systems Approach to the Pharmaceutical GMPs A Quick Comparison to ICH & ISO Planning and Implementing the Hybrid System

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