Events

Webinar on 21st Century Validation

Created by Adam Fleaming (See other events)
  • Oct 30, 2015 from 11:00 to 12:00
  • Location: Online
  • Latest Activity: Oct 12, 2020

Overview: 

The 'why' and 'what' and the events / background that have impacted validation over the last 25 years will be presented.

The importance of an organization's Quality System for validation will be put into perspective to help attendees identify potential gaps in their validation programs. The presentation will discuss the importance of 'focusing on critical aspects' and having meaningful, well-written User Requirements Specifications as key elements on establishing a streamlined and simplified validation program for capital projects. 

Why should you Attend: 

Today's pharmaceutical manufacturing company's compliance with global regulatory expectations should not be a difficult task - but many companies are still finding it to be a challenge to get it right. FDA and EU regulatory expectations have evolved over the last 20 years and a new 'improved' validation approach is emerging that offers validation and engineering organizations the possibility of streamlining and simplifying validation activities. 

Areas Covered in the Session:

  • 25 Years of Validation
  • Commissioning and Qualification (De-mystified)
  • Global Harmonization
  • EU vs US GMP (Regulatory Expectations)
  • The Importance of ASTM E2500
  • KISS Examples: Keep It Streamlined and Simple
  • Reasons for Poor Validation Programs
  • Q & A

Who Will Benefit:
  • Managers / Directors of Validation
  • Managers / Directors of Engineering
  • Managers / Directors of Quality Assurance
  • Sr. Validation Engineers and Project Managers
  • Regulatory Compliance Professionals

Speaker Profile:

Sam DeMarco is a Sr. Compliance Consultant and president of Compliance Team, Inc. Sam has over 25 years of technical, managerial, and consultative experience in the pharmaceutical and medical device industries. He earned his MBA from Loyola University of Chicago and BS in Mechanical Engineering from the University of Illinois. In 2009, he earned the International Society of Engineer’s certified pharmaceutical industry professional (CPIP) credential. His subject matter expertise covers a broad area of knowledge, which includes engineering, commissioning, validation, project management, quality assurance, and pharmaceutical manufacturing and product quality compliance. Sam’s comprehensive knowledge of and experience with implementing technical requirements for a diverse portfolio of projects has helped him to be an accomplished expert on developing robust quality system policies and procedures. His leadership has contributed too many successful launches of new manufacturing facilities, process technologies, and products in compliance with regulatory requirements and expectations.

Contact Detail:

NetZealous LLC DBA Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link: 

http://bit.ly/1NG6j5b
E-mail me when people leave their comments –
Follow

You need to be a member of Global Risk Community to add comments!

Join Global Risk Community

Upcoming Featured events

 

    About Us

    The GlobalRisk Community is a thriving community of risk managers and associated service providers. Our purpose is to foster business, networking and educational explorations among members. Our goal is to be the worlds premier Risk forum and contribute to better understanding of the complex world of risk.

    Business Partners

    For companies wanting to create a greater visibility for their products and services among their prospects in the Risk market: Send your business partnership request by filling in the form here!

lead