Date

August 19, 2020

Duration

60 - 75 minutes

Time

11 AM EDT / 8 AM PDT / 8:30 PM IST

Level

Advanced Professional

Why should you attend?

If you are a professional who is involved in a development and use of deviation management systems and often participate in investigations in pharmaceutical and biopharmaceutical industries this webinar is definitely for you. During this session we will discuss implementation of risk management and knowledge management pillars for the deviation system. We will talk about institutionalizing of effective and efficient investigational practices which include formation of effective teams of subject matter experts and quality assurance representatives from these organizations. We will discuss when, what and how of investigational practices and tools which make them effective. Additionally, attention will be given to communication of the outcomes of investigations as well as implementation of CAPA systems which will concentrate on prevention of deviation occurrences.

Areas covered
  • Deviation Systems
  • Corrective Action
  • Preventive Action
  • Quality Risk Management
  • Lifecycle Approach
  • Knowledge Management
  • Intra-facilities communication
  • Management commitment
Key learning objectives
  • Deviation System
  • CAPA
  • Risk Management
  • Knowledge Management
  • Control Strategy
  • Communication
  • Investigation
Who will benefit?

Professionals across:

  • Technical Services
  • Pharmaceutical Technology
  • Validation
  • Quality Assurance
  • R & D
  • Production
  • Quality Control
  • Engineering
  • Maintenance

Instructor Bio

Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He is currently holding a position of Senior Consultant at ConcordiaValsource, LLC. His over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and introduction of new products onto the market. He had published articles and white papers in pharmaceutical professional magazines and textbooks. In addition he had been a presenter at Interphex. He is also very active with PDA participating in several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He is leading PDA Water Interest Group.  He holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.

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