Overview:
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:
- 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
- Managers
- Operators
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.
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