Quality System Regulations for Drugs, Devices, and Tablets and How to generate your DMF 2014

Topics

• Gaining a more practical Comprehension from experience of the Quality Systems regulations
• What is expected from the QA professional and how other industries (FAA, ISO, EPA, etc.) have made Quality Systems so profitable by having the Head of Operations and the Head of Quality trading places every 6 months
• How to apply current technology to generate the objective evidence needed to generate the attitude of making the FDA successful when inspecting by answering all the potential inspector questions before asked. Use the applicable technology to think like an FDA inspector
• Once we have a better perspective then we will identify the necessary activities like working on a thesis to generate the needed performance for the entire Quality System
• Make sure we have the proper tools and comprehension to perform the needed internal audits which ensures that when a client audits the company or the FDA inspects the facility, we have already been doing all the things they might be reviewing
• How are we going to maintain documented evidence to prove that the process and initial validation is still working in accordance with the Quality System regulations
• Ensuring that vendors are practicing the similar quality performance to make sure we don`t get hit by their lack of consistency and quality performance based on the needed specifications for our process or products
• Making sure that all the laboratory, inspection, calibration, and related quality verification activities are working in a way that generates higher profitability by generating continuous quality improvement (CQI)
• Management of Incidents, Deviations, Changes - Incident tracking systems(ITS), deviation management (OOS, OOT, OOL, etc), Critical Change Control (CCR) and Corrections, Corrective Action and Preventative Action (CAPA)
• Defining the expected although not actually defined by the FDA what we need to demonstrate GDP (good documentation practices) which also serve as "legal" documents if something negative happens
• How to use statistics for Quality Systems and make sure that 6 Sigma is not being used during the validation activities
• Batch Production Record (BPR) or Device History Record (DHR) related to the master versions of the documents used for production and the review before release

Who should Attend

• Quality professionals
• Senior quality managers
• Compliance professionals
• Regulatory professionals
• New FDA Inspectors
• Production supervisors
• Production engineers
• Manufacturing engineers
• Process owners
• Design engineers
• Quality auditors
• Quality engineers
• Record retention specialists
• Document control specialists
• Legal Professionals
• Marketing and Medical Affairs