Igor Gorsky
Senior Consultant at ConcordiaValSource, LLC
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.
Upcoming Webinar
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Recorded Webinar
Auditing API Facilities
This webinar discusses auditing of Active Pharmaceutical Ingredients (API) facilities which is an important component of GMP quality assurance programs of pharmaceutical and biopharmaceutical firms. It is important to establish auditing function as part of a quality system and maintain monitoring and assessing it over a lifecycle of a product. This webinar will outline preparatory steps, pre-audit documentation and preparedness, as well as major topics of audit concentration of an audit. We will go over important questions to ask and necessary quality systems to review. We will also outline suggested areas for plant tours and pointers on what to look for. We will also review Industry Organizations such as APIC guidance for auditing.
Recorded Session Get life time access for one participant with download option!

Best Practices for Effective Pharma Technology Transfer: From R&D to Clinical to Commercial
This webinar discusses effective Pharmaceutical Technology Transfer procedures as they are currently practices by successful pharmaceutical and biopharmaceutical firms. It introduces compliant modular approach to technology transfer projects that covers multiple disciplines including Project Management, Analytical and Microbial Quality Control, Operations, Quality Assurance Safety, Engineering, Regulatory Affairs and other relevant areas. It provides guidance for creation of a powerful, effective and efficient governance team. In addition we will outline step-by-step joint quality review stage-gate approach that will help dissecting complex technology transfer exercises into manageable and compliant phases taking into consideration regulatory filing recommendations. We will also include discussion on Risk and Knowledge Management tools as they apply to Technology Transfer projects.
Recorded Session Get life time access for one participant with download option!

Risk Assessment in Cleaning Validation
This webinar discusses use of risk management as discussed in global guidances, such as ICH Q9 as they are currently available for pharmaceutical and biopharmaceutical industries. In addition, it describes use of QRM (quality risk management) in Cleaning Validation and growing trend of applying this approach to lifecycle of product manufacturing process. Establishing of health based Cleaning Validation limits also discussed in this session, as it is recommendation of ICH Q9. Additionally, recommendations on compliant and sustainable program will also be covered, as well as regulator's expectation for these programs.
Recorded Session Get life time access for one participant with download option!

Best Practices for Implementing an Effective Cleaning Validation using Principles of Upcoming ASTM E3106
This webinar discusses implementation of Cleaning Validation programs based on global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. What makes this webinar special and unique is a very rare glimpse into upcoming ASTM E3106 for Cleaning Validation. This is a Risk-Based Science-Based Lifecycle approach guidance document that was fully vetted with industry as well as with FDA. It is a first guidance document in the last 25 years (since the FDA Guidance of 1993) and it is based-on elements of ICH Q8-11 and Process Validation Guidance. In addition, this webinar describes use of QRM (quality risk management) in Cleaning Validation and growing trend of applying this approach to lifecycle of product manufacturing process. Establishing of health based Cleaning Validation limits also discussed in this session. Additionally, recommendations on compliant and sustainable program will also be covered, as well as regulator's expectation for these programs.
Recorded Session Get life time access for one participant with download option!

Application of Failure Mode and Effect Analysis (FMEA) for Process Risk Assessment
Regulations mandate effective use of quality risk management in a day-to-day, as well as a strategic enabler of quality in pharmaceutical and biopharmaceutical research and development, operation and distribution. This course is designed to provide information on the background regulatory guidance on Risk Management - the ICH Q9 document. Give an aid by providing some points of discussions on the understanding of the quality risk management concepts, and illustrations of how Risk Management can be applied in pharmaceutical and biopharmaceutical products' manufacture using specific tools like an FMEA (Failure Mode Failure and Effect Analyses). Specific examples of usage of this technique will be shown. In addition, other methods acceptable by ICH Q9 will be mentioned.
Recorded Session Get life time access for one participant with download option!

Avoiding Investigational Failures and Reducing Discrepancies
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.
Recorded Session Get life time access for one participant with download option!

Risk Assessment in Cleaning Validation
This webinar discusses the use of risk management in global guidance, such as ICH Q9 as they are currently available for pharmaceutical and biopharmaceutical industries. In addition, it describes use of QRM (quality risk management) in Cleaning Validation and growing trend of applying this approach to lifecycle of product manufacturing process. Establishing of health based Cleaning Validation limits also discussed in this session, as it is recommendation of ICH Q9. Additionally, recommendations on compliant and sustainable program will also be covered, as well as regulator's expectation for these programs.
Recorded Session Get life time access for one participant with download option!

Cleaning Validation Guidelines
This webinar discusses global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. In addition, it describes use of QRM (quality risk management) in Cleaning Validation and growing trend of applying this approach to lifecycle of product manufacturing process. Establishing of health based Cleaning Validation limits also discussed in this session. Additionally, recommendations on compliant and sustainable program will also be covered, as well as regulator's expectation for these programs.
Recorded Session Get life time access for one participant with download option!

Auditing API Facilities
This webinar discusses auditing of Active Pharmaceutical Ingredients (API) facilities which is an important component of GMP quality assurance programs of pharmaceutical and biopharmaceutical firms. It is important to establish auditing function as part of a quality system and maintain monitoring and assessing it over a lifecycle of a product. This webinar will outline preparatory steps, pre-audit documentation and preparedness, as well as major topics of audit concentration of an audit. We will go over important questions to ask and necessary quality systems to review. We will also outline suggested areas for plant tours and pointers on what to look for. We will also review Industry Organizations such as APIC guidances for auditing.
Recorded Session Get life time access for one participant with download option!

Best Practices for Effective Pharma Technology Transfer: From R&D to Clinical to Commercial
This webinar discusses effective Pharmaceutical Technology Transfer procedures as they are currently practices by successful pharmaceutical and biopharmaceutical firms. It introduces compliant modular approach to technology transfer projects that covers multiple disciplines including Project Management, Analytical and Microbial Quality Control, Operations, Quality Assurance Safety, Engineering, Regulatory Affairs and other relevant areas. It provides guidance for creation of a powerful, effective and efficient governance team. In addition we will outline step-by-step joint quality review stage-gate approach that will help dissecting complex technology transfer exercises into manageable and compliant phases taking into consideration regulatory filing recommendations. We will also include discussion on Risk and Knowledge Management tools as they apply to Technology Transfer projects.
Recorded Session Get life time access for one participant with download option!

Cleaning Validation Guidelines
This webinar discusses global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. In addition, it describes use of QRM (quality risk management) in Cleaning Validation and growing trend of applying this approach to lifecycle of product manufacturing process. Establishing of health based Cleaning Validation limits also discussed in this session. Additionally, recommendations on compliant and sustainable program will also be covered, as well as regulator’s expectation for these programs.
Recorded Session Get life time access for one participant with download option!

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