Webinar On Corrective and Preventative Action (CAPA) Throughout the Product Lifecycle

Compliance Trainings, Online
2014-11-14

This webinar will discuss how the CAPA system and associated processes such as design control, risk management, process control, and investigations can be utilized throughout the product lifecycle to address defect prevention. Both medical devices and pharmaceuticals will be included.

By attending this webinar, you’ll gain very valuable insight into how CAPA systems work and function to satisfy user and patient requirements. You will gain insight on how your CAPA system works and ways to improve it. Perhaps the greatest benefit will be a better understanding of the quality system in ways that you can apply its principles throughout the product lifecycle for better design and risk control.

First, the CAPA total lifecycle (starting with defect discovery to final verification of root cause) will be discussed and analyzed. Then, starting with R&D, the product life cycles will be followed to show how the CAPA lifecycle changes and evolves throughout the product lifecycle stages and ways to use this data not only for defect prevention but also for more consistent production and product and process improvement. The final discussion covers the post-approval stage of the product lifecycle.

The webinar will include a PowerPoint presentation followed by a presentation of flowcharts that logically sequences the activities of the CAPA system.

Objectives of the Presentation:

Understand the importance of starting the CAPA system ASAP in the product lifecycle

Understand how the CAPA lifecycle changes from R&D to commercialization

Gain insight on how to make more effective use of the CAPA system

Areas Covered in the Session :

Introduction, Purpose, and Overview

Defining the quality system from R&D to product discontinuation

Brief review of the device and pharmaceutical lifecycles

Regulatory requirements and Guidance recommendations CAPA systems

Quality Principles that apply to CAPA systems

The CAPA lifecycle from defect discovery to file verification of defect cause (PowerPoint & flowchart)

The product lifecycle to Research and Development to Product Discontinuation (PowerPoint & flowchart)

Example of a CAPA procedure in flowchart format

Who Will Benefit:

Quality and Regulatory Affairs

Quality Control Laboratory

Senior Management

Management Representatives

Inter-functional departments such as

Production Department

Maintenance Department

Purchasing Department

Warehousing Department

Sales and Marketing Department

Purchasing Department

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1067

Howard T Cooper, President, EQACT, Inc., Independent Consultant, has over 40 years of experience facing the challenges of managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which exposed him to an advanced and preventative approach toward quality. He then took this experience to the medical device industry when the medical device amendments of 1976 were being written and promulgated. He quickly distinguished himself as a change agent and a forward thinking quality leader. Mr. Cooper built on this experience to set up a pharmaceutical /medical device in combination product quality system. Since that time, he has worked with incubators, small companies, and large international corporations in the quality and regulatory affairs. In 2004, he became an independent consultant continuing his work to manage, develop, and implement quality. Mr. Cooper particularly enjoys sharing his experience with others to further develop them for successfully running quality operations.

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