Sprecher
Discuss the important new FDA Guideline on Quality Metrics with key representatives from FDA and EU Industry:
Karthik Iyer, FDA, Acting Branch Chief in CDER/Office of Pharmaceutical Quality/Office of Surveillance
Alex Viehmann, FDA, Operations Research Analyst in the Office of Surveillance – Quality Intelligence Branch
Gundeep Ahluwalia, FDA, Deputy Director (Acting),Office of Business Informatics, Center for Drug Evaluation and Research
Russell Upchurch, UCB, Director GMP Corporate QA
Richard (Dick) Bonner, ECA Foundation, ECA and European QP Association
Chairman
Dr Rainer Gnibl, EU GMP Inspector
Zielsetzung
This Regulatory Meeting is a unique opportunity for delegates from EU Industry to discuss the upcoming new FDA Guideline on Quality Metrics. The new Guideline will have a comprehensive impact on industry and authority.
FDA will use the Quality Metrics to schedule inspections based on risk assessment, improve the efficiency and effectiveness of these inspections and also reduce product-related shortages and recalls.
We invite you to discuss with FDAs experts about FDA´s expectation in all details. For this, three FDA representatives will join the Regulatory Meeting. Speakers from industry and EU Inspectorate will complement the event.
Hintergrund
In the last months, the U.S. Food and Drug Administration (FDA) has set up an initiative to use Quality Metrics for planning their risk based inspections. This development was triggered by the Food and Drug Administration Safety and Innovation Act (FDASIA; Title VII, section 706). The goal of the Guidance is to give FDA the authority to collect Quality Metrics from production sites supplying APIs, medicinal products, Biotech, OTC etc. to the US. They should provide data about the “quality level” in each manufacturing site. By this, FDA wants be able to see how well quality systems are maintained. In the future, companies will need to conduct continual monitoring, assessment and reporting on the state of quality across their drug products and facilities regulated by FDA.
The FDA Draft Guidance for Industry “Request for Quality Metrics” will be finalized soon and each company which supplies products to the US market will have to meet the demands defined in the Guidance Document.
Zielgruppe
All GMP and QA experts dealing with FDA requirements.
Programm
Update on draft Quality Metrics guidance
Highlight key areas based on webinar and public meeting
Common themes submitted to the public docket
• Karthik Iyer, FDA
Acting Branch Chief in CDER/Office of Pharmaceutical Quality/Office of Surveillance
cGMP Manufacturing Statistics
Overview of the statistical methods the Agency plans to utilize for model building
Establishing a signal detection program based on quality metrics data submitted
• Alex Viehmann, FDA
Operations Research Analyst in the Office of Surveillance – Quality Intelligence Branch
CDER Informatics – Enabling the Quality Metrics
Gundeep Ahluwalia, FDA
Deputy Director (Acting), Office of Business Informatics, Center for Drug Evaluation and Research,
Quality Metrics - Current Use and Expectations
Quality Metrics in the EU GMP Pharmaceutical Quality System
“State of control”
Quality Management Review
The ECA Survey on Quality Metrics –
April/May 2015
Results and Expectations
• Richard (Dick) Bonner, ECA Foundation, ECA and
European QP Association Chairman
Building a Global Model for Risk Based Surveillance and Prioritization: Initiative Analysis and Response to FDA Draft Guidance, Request for Quality Metrics, UCB, Inc
Introduction to UCB Inc
Importance of a Quality Metrics Program
Assessment of FDA Draft Guidance, Request for Quality Metrics
Comments to Draft Guidance
Recommendations
• Russel Upchurch, UCB, Director GMP Corporate QA,
Quality Metrics from an EU GMP Inspector’s point of view
Impact on EU-companies and how to deal with it
EU-approach on authorities risk based inspection planning vs. US Quality Metrics approach
Typical “Quality Metrics” an EU Inspector will look at based on EU-GMP Guideline
Typical indicators for a lack of Quality Assurance/ Quality Culture from EU-inspectors view
• Dr Rainer Gnibl, GMP Inspector, District Government of Upper Franconia, Germany
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