Webinar on Proactive Internal Auditing-The Key to Establishing, Maintaining, and Improving Quality Systems

This webinar provides a broad overview of the internal auditing functions starting with the concept of quality systems and their objectives, primarily using graphical methods. The webinar focuses on the role of the internal audit function throughout the product lifecycle. It focuses on the importance of using knowledge to prevent failure and to improve the quality system.

The internal audit is part of a monitoring system that provides Senior Management with the knowledge to act as needed to maintain and improve the associated quality processes. While  the internal audit is inherent in the device regulations, the internal audit in the pharmaceutical environment has been less structured but has become more formalized structured in the FDA 2006 guidance, The Quality Systems Approach To the Pharmaceutical Good Manufacturing Practices. In 2008, ICH published, ICH Q10, Pharmaceutical  Quality Systems, that describes the role of audits in maintaining and improving the quality system. The FDA adopted ICH Q10 in 2012.

The FDA regulated industry at all levels fear FDA inspections. The most likely reason for this fear is that deficiencies will be found that require significant actions and time to correct. A proactive internal auditing system providing ongoing communications to management combined with appropriate management action can relieve these fears and provide greater confidence.

Middle and Senior Management from all functions involved in establishing and executing corporate strategy and objectives. It is particularly applicable to companies new to the FDA regulated industry.

Senior quality management will gain insight on how quality systems work and will be able to better understand senior management responsibilities. Provide knowledge that can be used to persuade others concerning quality matters.

Finance, Sales and Marketing, Operations, Procurement, and Human Resources who have an active or supporting role in Quality.

Other quality personnel who have the desire and/or potential to advance to quality leadership.

Areas Covered in the Session :

Defining and describing the modern quality system and its life-cycle

What are the objectives of internal auditing?

Defining the audit process and its cycle

Organizing the quality audit functions

Can a job description be written for an internal auditor?

Auditing Responsibilities

in the internal audit is not the same as FDA inspection

Auditing may be both subjective and objective

The inter-functional audit team

Going way beyond the audit checklist

Categorizing findings-CAPA, remediation, or improvement

The audit report life-cycle

Internal Auditing trends

FDA enforcement of internal audit requirements

Who Will Benefit:

Middle and Senior Management

Companies new to the FDA regulated industry

Quality Assurance

Quality Control

Regulatory Affairs

Senior quality management

Compliance Director

Vice Presidents

Consultants

Project Leaders

Research & Development

Sales and Marketing, Finance & Cost Accounting, and Procurement Departments

Operations Department

Human Resources who have an active or supporting role in Quality

Other quality personnel who have the desire and/or potential to advance to quality leadership

 Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899