Establishment of Quality Systems
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Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.
Why should you Attend: The reason for attending would be to gain a perspective on what the expectations of a quality system are as they applies to validation and the requirements of regulations for the pharmaceutical and medical device industries.
Areas Covered in the Session:
Who Will Benefit:
- Regulatory expectation regarding quality systems
- How to establish quality systems
- Quality systems fundamental
- FDA definitions
- Fitting within the FDA puzzle
- How to maintain and operate within a quality environment
- QA specialist
- Quality Systems Specialist
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.
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.