CAPA Simplified - A one-form, easy-to-complete, method for simplifying your CAPA process

Website https://www.traininng.com/webinar/-200729live?channel=ourglocal-march_2019_SEO | Edit Freely

Category online training courses for hr professionals,online training programs for hr professionals, HR Training and Development

Deadline: March 25, 2019 | Date: March 25, 2019

Venue/Country: Online Event, U.S.A

Updated: 2019-02-28 16:10:15 (GMT+9)

Call For Papers - CFP

This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), examples of documentation you can use to fulfill the CAPA requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site.

We will also go over some additional tips and tricks on how to convey the importance of CAPA within your organization and ensure resources are provided to meet CAPA process needs. At the end of the presentation, I will answer any questions or concerns you may have regarding the CAPA process.

Why should you Attend

Get an in-depth understanding of regulatory agencies such as the FDA requiring for CAPA

Evaluate your already-existing CAPA process to determine if it meets requirements

Determine if your CAPA system is robust enough to ensure actions are effective or overly-complicated and preventing smooth operation

Overview of commonly-used root cause analysis functions

Understand some misconceptions with CAPA implementation

Tips and tricks for implementing a successful CAPA system

Areas Covered in the Session

Regulatory requirements for CAPA

Responsibilities of manufacturers

Best practices for CAPA implementation

FDA expectations

Documentation requirements

Who Will Benefit

Quality Control Personnel & Management

Manufacturing Personnel & Management

Senior Management

Regulatory Affairs Personnel & Management

Quality Assurance Personnel & Management

Supplier Quality Personnel & Management

Development Engineers

Production Management

QA/QC Personnel

Software Developers

Usability engineers

Risk managers

Design Engineering Managers

Medical Device Engineering

Quality Assurance

Regulatory

Management

Speaker Profile

Denise Wrestler ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA's "least burdensome approach" and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.

Event link: https://www.traininng.com/webinar/-200729live?channel=ourglocal-march_2019_SEO

Contact Info

Traininng.com LLC

Email: traininngdotcomgmail.com

Phone: US: (510) 962-8903

Phone: Zurich: +41 - 43 434 80 33

Website : https://www.traininng.com