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Showing posts with the label Quality professionals

Understanding and Implementing a Quality by Design Program

ComplianceKEY -  Regulatory compliance training Overview The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised. Most important are the direct benefits to our primary customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration "All products are designed and developed to be of high quality; QbD provides a structured framework for developing, documenting and presenting development rationale, experience and knowledge of the formulation and the process, and to ensure manufacture of products consistently fit for patient use." Application of these principles can also benefit the pharmaceutical companies by improving manufacturing efficiency and promoting innovation. However, implementing these principles into the pharmaceutical development culture can be challenging. QbD involves a complex set of interactions, technologies and systems that ar...

How to Perform Measurement Systems Analysis

Compliance Key INC  -  Enterprise Risk Management training                                             William A. Levinson William A. Levinson, P.E., is Keynote Speaker at Compliance key Inc. He is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt.  Webinar Id:  LSHCHWL003  10:00 am PT | 01:00 pm ET  02/13/2018  Duration 60 mins  Overview Measurement systems analysis (MSA) is the counterpart of calibration. Calibration ensures the accuracy of gages and instruments, while MSA measures their precision. Accuracy reflects the gage's ability to, on average, return the actual dimension of the part on which it is used. Precision measures the gage's ability to get consistent meas...

Course Description - How to Write and Manage a Change Control System

              Compliance Key INC -  FDA compliance training                                             Danielle DeLucy Danielle DeLucy, MS, is Keynote speaker at Compliance Key, Inc. She is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices.  Webinar Id:  LSHCSDD005  10:00 AM PT | 01:00 PM ET  10/24/2017  Duration 60 mins   Overview This webinar will help attendees understand the fundamental change control steps and processes. It will focus...