World Conference Calendar

35139 Conferences

Auditing for validation

Added by Compliance4all on 2014-11-24

Conference Dates:

Start Date Start Date: 2014-12-18
Last Date Last Day: 2014-12-18
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2014-12-17

Conference Contact Info:

Contact Person Contact Person: Event Co-odinator
Email Email:
Address Address: Online Event, Fremont, California, 94539, United States
Phone Tel: +1-800-447-9407

Conference Description:

The audit function is a fundamental tool used by the quality unit of a firm to demonstrate compliance with regulatory and client company expectations. This presentation will discuss the expectations of validation as a quality system that should be in place at a vendor or external manufacturer. Auditing is a basic function of any firm engaged in heavily regulated industries such as pharmaceuticals and medical devices.

Why should you Attend: The reason for attending would be to gain a perspective on what the expectation of vendors should be as it applies to validation and the requirements of regulations for the practice of validation.

Areas Covered in the Session:

Basic principles of auditing
What to look for and how to interpret
What is important from a validation perspective
Domestic versus overseas validation auditing
Regulatory comparisons and expectations
Making the assessments and drawing a conclusion
Your auditing report and your submission of findings

Who Will Benefit:
QA specialist
Validation specialist

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 organizationís 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.

Lou is currently employed by Validant a Quality, Regulatory and Engineering consulting firm with expertise in biotechnology, pharmaceutical and medical device industries. Lou is a Quality Systems Consultant specializing in Validation and Quality System Consent Decree administration and remediation.
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