Dates/times:
Wednesday, September 07 2016 at 01:00 PM (Get Tickets)
Location:
Webiar
USA
Newyork, NY 10018
Event Description:
Qualification of Facilities and Equipment
Location: Attend Live Webinar
Dates: 07-Sep-2016: 1:00 PM EST
Duration: 60Mins
Speaker : Igor Gorsky
Igor Gorsky, Sr. Consultant, ConcordiaValsource, LLC. He has over 30 years of experience leading validation, technology transfer, quality assurance and manufacturing functions in a wide range of pharmaceutical and biotechnology generic and brand firms. Prior to Concordia Valsource, Igor served as an Associate Director of Validation at Shire Pharmaceuticals where he oversaw validation activities for Shire Specialty Pharmaceuticals Supply Chain providing support to Shire owned sites as well as working closely with Shire’s numerous Contract Manufacturing Organizations. In addition, at Shire Igor was a member of Global Pharmaceutical Technology Leadership Team. At Wyeth Igor led Data Analysis group that was responsible for Knowledge Management and Understanding of multiple areas in development, validation and production of multi-billion dollar Branded Conjugated Estrogen Therapy franchise. At Alpharma Igor managed manufacturing, quality assurance, technical services and validation groups. Igor is a frequent speaker/writer on topics such as Cleaning Validation, Compressed Air Systems Design, HVAC Design and Environmental Monitoring, Parenteral Products Scale-up, Process Validation, and QbD. He is an active member of a number of industry associations (PDA, ISPE and ASTM). His involvement includes: being a Parenteral Drug Association’s (PDA) Pharmaceutical Water Interest Group Leader, a member of PDA Process Validation (TR60, 2013 publishing), Cleaning Validation (TR29, 2012 Publishing) and Knowledge Management Technical Reports’ teams. He also authored a chapter on Parenteral Drug Scale-Up in the Pharmaceutical Process Scale-Up which is currently on its third edition.
Course Description:
If you are a professional who is involved in planning, design, purchase, qualification, validation and continuous lifecycle of Facilities and Equipment this webinar is definitely for you. During this session we will demystify an entire lifecycle risk-based approach to qualification of facilities and equipment which is vital to successful process validation of pharmaceutical and bio-pharmaceutical products as well as sustainable and reproducible subsequent manufacturing activities. In the age when regulators expect from pharmaceutical industry risk-based decisions this webinar is a must for those professionals who are responsible for seamless non-stop operation of facilities and equipment that support manufacturing of product that continuously meet product and process specifications. In addition we will review case studies from recent regulatory observations which will help participants to learn from other companies’ shortcomings.
Course Objective:
Dispel mistaken paradigms regarding the risk based approach to Qualification of Facilities and Equipment lifecycle.
Understand how to eliminate variability – the cause of most deviations.
Understand how to best design facilities and equipment that would support manufacturing of that will continually meet product and process requirements.
Capitalize on the advantages of on-line analytical instrumentation (temperature, relative humidity, and even microbiological rapid methods)
Course Outline:
Risk Based Approach
Design of Facilities and Equipment
Installation Qualification Concept
Operation Qualification – What is Involved
Performance Qualification for Equipment and Facilities
Sampling Schemes
Data Analysis
Continued Verification
Target Audience:
This webinar is targeted toward the following organizational positions and disciplines. It will be discussed in a pragmatic and practical understandable language by all technically educated or trained professional. This information would be useful at levels from senior management to those who is involved in operation of Facilities and Equipment on a day-today basis. It would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to Facilities and Equipment design, installation qualification, maintenance and continued monitoring:
Quality Assurance/ Quality Control (Chemistry and Micro)
Process and Design Engineering
Process Automation
Manufacturing Operations
Validation
Utility Operations
Regulatory Affairs
Please Click here to Enroll & for more details
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Sean Sharpe,
Training Manager,
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