FDA Guideline 2016 - Conference about 2011 FDA Guideline on Process Validation

Overview:
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Why should you attend:
This is a topic very near and dear to those who are involved with qualification and validation. Of all the topics regarding compliance this subject area has to be the most re-invented. Those in attendance will hear how to approach the topic and what some companies are currently doing to meet the expectation. If you are new to the topic or just want to learn more regarding this evolving area of compliance then consider attending this session.
Areas Covered in the Session:
What it means
What it says
What is in and what is out
Comparison of what has changed
PPQ1 and PPQ2
What is PV
What is Qualification
ASTM 2500
European interpretation
Inconsistencies
Hybrid compliance
Hyper-care
The 3X rule
What is validation and what is not
Who Will Benefit:
Compliance Personnel
QA Personnel
validation Personnel
Speaker Profile:
Louis Angelucci is a pharmaceutical professional and Certified Quality Engineer with over 20 years of experience in Quality Assurance, Quality Control, Validation, consent decree remediation as well as cGMP Compliance in the Medical Device and Pharmaceutical industries. Lou has worked for several well know companies inclusive of Johnson & Johnson, Bristol-Meyer Squibb, Pfizer, Schering Plough and Merck. This work experience was acquired either as a direct employee or as a contracting consultant while employed at Foster Wheeler and Aker Kvaerner. As a consultant Lou has worked at various project locations both domestically and overseas. Lou is a member of the IVT board of Directors and has been a contributing speaker to IVT since the organization’s early beginnings. He has published numerous articles on the subjects of Validation and compliance and has been a speaker to industry groups such as ISPE, IDE, PDA and ASQ.
Contact Detail:
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/2011_FDA_Guideline_on_Process_Valida...