Avoiding Investigational Failures and Reducing Discrepancies

Duration: 90 Minutes
This webinar discusses avenues to be taken to avoid investigational failures and to reduce discrepancies. A robust investigational management system is always based on implementation of risk management and knowledge management pillars in pharmaceutical and biopharmaceutical organizations, as prescribed by ICH Q10. In addition, it is based on effective and efficient investigational practices which include formation of effective teams of subject matter experts and quality assurance representatives from these organizations. These subjects are going to be discussed along with effective techniques of conducting timely and value added investigations which results in corrective and more importantly preventative actions which would allow manufacturers not to make same mistakes twice and to reduce discrepancies while learning, as an organization.
How to avoid Investigational Failures
Instructor: Igor Gorsky
Product ID: 509763
Objectives of the Presentation
  • Deviation System
  • CAPA
  • Risk Management
  • Knowledge Management
  • Control Strategy
  • Communication
  • Investigation
Why Should you Attend
If you are a professional who is involved in a development 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 so that we can reduce discrepancies. 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 and more importantly efficient (most investigations completed in 14 days or less). 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 and training practices.

Areas Covered
  • Deviation Systems
  • Corrective Action
  • Preventative Action
  • Quality Risk Management
  • Lifecycle Approach
  • Knowledge Management
  • Intra-facilities communication
  • Management commitment
Who will Benefit
  • Technical Services
  • Pharmaceutical Technology
  • Validation
  • Quality Assurance
  • R & D
  • Production
  • Quality Control
  • Engineering
  • Maintenance
Topic Background
Effective and robust deviation system should aid in correction and prevention of errors. In addition it should be agile and prompt in resolving investigation, properly documenting them and providing communication to all parties involved including management so that future risks could be properly assessed and lessons learned from resolving investigational issues.
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  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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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