Understanding FDA's Quality Metrics Draft Guidance and Its Impact
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To gain insight with regard to future expectations of the FDA with regard to quality metrics. Since the publication of the draft guidance there have been independent studies performed on behalf of the FDA.
In addition the FDA also published a complimentary document in support of the original guidance. Though the FDA has not finalized this guidance it appears that the FDA is making moves to have it finalized but keeping it alive and supporting the initiative with other publications.
This particular guidance will have a dramatic impact on the industry in terms of submitting on a yearly basis metrics associated with each and every product manufactured by a firm. It is important to understand this guidance and begin preparations to meet the requirements associated with it.
Areas Covered in the Session:
Who Will Benefit:
- An introduction into the requirements associated with the FDA draft guidance on Quality Metrics.
- In addition a summarization of the independent surveys from industry organizations
- The complimentary documents associated with quality metrics
- 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.