Expectations of Regulatory & Validation Master Planning - 2017

This presentation will cover the importance of master planning. The FDA and other regulatory bodies expect these to be among the Quality System documentation.

Areas Covered in the Session:

History and background
Types
Organization
Requirements
Regulatory expectations
Maintenance

Who Will Benefit:

Compliance Personnel
QA Personnel
Validation Personnel

Speaker and Presenter Information

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.