THIS WEBINAR WILL DEFINE THE CONCEPTS BEHIND THE A 2013 - Effective, Risk Based Implementation of the Quality Systems

Sign for Notice Everyday

Home Post Event 2025Event 2026Event By Topic By Country Contact

Our Sponsors

THIS WEBINAR WILL DEFINE THE CONCEPTS BEHIND THE A 2013 - Effective, Risk Based Implementation of the Quality Systems - Webinar By GlobalCompliancePanel

Website http://bit.ly/WB3eui | Edit Freely

Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Heath,FDA

Deadline: April 04, 2013 | Date: April 04, 2013

Venue/Country: California, U.S.A

Updated: 2013-03-20 15:45:09 (GMT+9)

Call For Papers - CFP

Overview: This webinar will define the concepts behind the application of the Quality systems to drug operations and the specific elements as discussed on the ICH Q-10. The course will include specific discussions on the enablers for the QS implementation and on each QS element from a risk-based approach so that the specific requirements can be prioritized based on the highest impact to product quality and this prioritization scheme can be applied during the implementation. The specific requirements to be addressed in detail include: CAPA, Internal Audits and Change Control. As a result, an effective plan for compliance can be developed and executed.

Why should you attend: These guidelines have been effective since 2006 and 2009 respectively and many companies are still struggling on how to implement these requirements effectively. They may have Change Control, CAPA, Internal Audits but these are not being executed with positive concrete results.

Areas Covered in the Session:

Q10 Enablers and their applications

CAPA

Internal Audits

Change Control

Course Modules & Content Details:

Regulatory Background - FDA guidance and ICH Q10

Why A Harmonized Approach to a Comprehensive, Modern and Robust Quality System? Why Q10?

ICH Q-10 Enablers and their importance

ICH Q-10 elements and their role:

Quality Manual - Policy, Quality Plans and Management Role

Management Responsibility as "Ultimate Responsible for QS" - Commitment, Quality Policy, Planning, Resources, Communication and Review

Continual Improvement of Process Performance and Product Quality - Monitoring, CAPA, Change Management and Management Review

Continual Improvement of the Pharmaceutical Quality System - Internal Audits

Who Will Benefit:

Manufacturing

R&D

Quality

Validation

Engineering

Top Management

Miguel Montalvo, B.S. Chem. Eng., MBA, President, Expert Validation Consulting, has over twenty-eight years of professional/management experience in positions of increasing responsibility in the areas of Quality, Validations and Technical Services within the traditional pharmaceutical, OTC Drugs, cosmetics, dietary supplements, biotechnology.

USA

GlobalCompliancePanel,

Livermore Common, Fremont, CA, 94539

USA Phone:800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

http://bit.ly/WB3eui

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.