Compliance Key - Compliance Online Training Webinars, Regulatory, Medical Device, FDA, Financia

Compliance Key INC  - Life Science Webinars   Overview Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system. Why should you attend this webinar? Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed air system with its individual components is provided. Engineering schematics are ...

Overview This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed. Why should you attend this webinar? The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters. Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations Areas Covered in the Session: FDA requirements for handling OOS/ OOT results Ph...

Compliance Key INC  -  Medical Device Training                                             Roger Cowan Roger Cowan is the Keynote Spaker at Compliance Key Inc. He is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years experience in pharmaceutical quality assurance and manufacturing.  Webinar Id:  LSHCRC005  10:00 AM PT | 01:00 PM ET  11/17/2017  Duration 60 mins  Overview Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product....

       Compliance Key INC - Medical Device Training                                                 Roger Cowan Roger Cowan is the Keynote Spaker at Compliance Key Inc . He is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years experience in pharmaceutical quality assurance and manufacturing.  Webinar Id:  LSHCRC006  12:30 PM PT | 03:30 PM ET  10/20/2017  Duration 60 mins   Overview Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial t...

                                                       Charles Paul Charles H. Paul is Keynote Speaker at Compliance key Inc. He is President of C. H. Paul Consulting, Inc. - a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence.  Webinar Id:  LSHCCP009 Date:10.00 AM PST | 01.00 PM EST Time:  09/06/2017 Duration 60 mins  Overview Compliance documentation to include Standard Operating Procedures - the documentation required by regulation - ...