Quality Management System effectiveness: What you can impact in reactive versus proactive systems and Quality Management System effectiveness: ICH Q10 principles, impact of failure on COGS, principles of QRM, what you can impact in reactive versus proactive

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Category Healthcare

Deadline: April 15, 2015 | Date: April 15, 2015

Venue/Country: Online, U.S.A

Updated: 2015-03-27 18:14:53 (GMT+9)

Call For Papers - CFP

"Part 1 - Quality Management System effectiveness: What you can impact in reactive versus proactive systems" - By Larry Spears

Wednesday March-25-2015 01:00 PM | 02:30 PM - EST

It is critical to any pharmaceutical manufacturing operation that an effective quality management system is operational and functioning as intended. For the US market, the FDA regulates that industry very actively through challenging and well-established regulations. Internationally, there are various country-specific regulations but standards for pharmaceutical manufacturing quality are largely outlined in Q10 principles and in the established principles of Quality Risk Management (QRM), which are part of ICH, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Why should you attend :

To understand current guidance, principles, and best practices to achieve quality in pharmaceutical manufacturing. While ICH focuses primarily on Europe, Japan, and the US, this class will specifically address US regulation, which provides valuable exposure and training for attendees from other countries and regions regarding how the FDA evaluates Quality Management Systems. COGS, QRM

Areas Covered in the Session:

US pharmaceutical regulations

Benefits of Proactive Quality Systems

Importance of management responsibility in quality system management

Importance of good documentation practices

Who will benefit: (Titles)

Business Owners & Senior Managers/Managers and Leaders in:

Quality Assurance

Production and Operations

Product Development

Regulatory Affairs

Marketing/Advertising

Labeling

"Part 2 - Quality Management System effectiveness: ICH Q10 principles, impact of failure on COGS, principles of QRM, what you can impact in reactive versus proactive" -By Angela Bazigos

Wednesday April-22-2015 01:00 PM | 02:30 PM - EST

It is critical to any pharmaceutical manufacturing operation that an effective quality management system is operational and functioning as intended. For the US market, the FDA regulates that industry very actively through challenging and well-established regulations. Internationally, there are various country-specific regulations but standards for pharmaceutical manufacturing quality are largely outlined in Q10 principles and in the established principles of Quality Risk Management (QRM), which are part of ICH, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH is an organization that covers the science and technical parts of drug registration through discussions between regulators and the pharmaceutical industry in Europe, Japan and the US. The mission of ICH is to achieve greater harmonization to ensure that medications are safe, effective, and of high quality and that the drug registration process is efficient.

Why should you attend :

The ICH documents Q8, Q9, and Q10 have been gaining attention recently with the new FDA quality metrics initiative and the announcement of the FDA’s pilot program for training inspectors to assess a quality culture. Additionally, there are other guidances (like FDA’s Process Validation Guidance) and requirements (like the cGMPs) that have to be factored into the process. This means that expectations set in these guidances won’t be optional for much longer, and organizations must assess their own operations for “Quality by Design” (QbD) compliance.

This webinar will focus on ICH Q10, its contents and its impact on your organization. It will enable you to understand how all these guidances fit together, how to move from the current environment to ICH Q10, how to implement ICH Q10/ QbD and how to assess your organization for ICH Q10/ QbD Readiness.

Areas Covered in the Session

Spending the time to incorporate the latest QbD expectations into your operations is critical. In this 90-minute webinar you will learn:

The differences between the old GMP mindset and the new quality systems mindset ? and how they both affect our daily operations

What ICH Q10 covers, including scope and applicability to the various parts of the operations

All of the parts required for an effective quality system (per these guidance and regulations), and how the systems should interact

How to assess your own site processes and systems against the guidance

Who will benefit: (Titles)

This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale. This includes quality, validation, manufacturing, development and all management personnel from sponsors and contract manufacturers (CMO) alike. Additionally, the following will benefit

Business Owners

Senior Managers/Managers and Leaders in:

Quality Assurance

Production and Operations

Product Development

Regulatory Affairs

Marketing/Advertising

Labeling

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live each Presentation On 25th March and 22nd April.

Certificate of Attendance

You can Also buy Part 1 or Part 2 individually at :

"Part 1 - Quality Management System effectiveness: What you can impact in reactive versus proactive systems"

"Part 2 - Quality Management System effectiveness: ICH Q10 principles, impact of failure on COGS, principles of QRM, what you can impact in reactive versus proactive"