Conference Description:

The Purpose of this Course is to Review ICH Q10, which is a Document developed by the 3 Countries Comprising ICH (Us, Eu, Japan). ICH Q10 is for the Development of a Pharmaceutical Quality System, In Conjunction with the Companion Documents, ICH Q8, Pharmaceutical Development and ICH Q9, Quality Risk Management. In Addition to the Members of ICH (Us, Eu And Japan), Many Other Groups were involved in the Expert Working Committees that were involved in the Development of these Documents, Etc. Therefore, establishing a Pqs, Implementation and use throughout the Lifecycle of the Product (From Development to Product Discontinuation), Along with use of the ICH Q8 and ICH Q9 Companion Documents, is a Global Expectation of Regulatory Authorities. The Information that is contained within these Documents (Such as Module 3 Section Regarding Pharmaceutical Development and Justification of Product Development) are necessary for Regulatory Submission of New or Modified Products, Including Information Required for the Common Technical Document (The Regulatory Submission Requirements for New Products (of Chemical and Biological/Biotechnological Origin). In Addition, We will discuss the Development of the Drug Substance during this Course (ICH Q7 and ICH Q11), which is also a required part of the Regulatory Submission/Marketing Application, which requires a History, Justification, etc. of the Design and Development of the Drug Substance (Or API), In Addition to the Drug Product..

Why should you attend:
Manufacturer’s and Sponsors, as well as Contract Manufacturing Organizations should attend because establishing, implementing and maintaining a PQS across the Product Lifecycle (from development to product discontinutation) is a global expectation. Global Agencies (including FDA) are conducting regulatory audits against the PQS, and implementation of the PQS in conjunction with the documents that ICH created to meet the objectives of the PQS (ICH Q8, pharmaceutical development and quality risk management) is a global expectation. The benefits of establishing a PQS beyond the fact that it is an expectations include being able to establish a design space, which will allow Companies to make changes within the design space, without a requirement for a post-approval regulatory filing, therefore allowing Science and Risk based Changes that do not have to be filed if they stay in the design space. Other benefits, along with requirements, accompany the implementation of a Pharmaceutical Quality System (PQS).

Who will benefit:
Product Development Personnel (Formulation scientists, Formulation chemists, etc. or Geneticists, R & D Scientists
Process Development Personnel
Technology Transfer personnel
Validation Engineers/Validation Manager
Quality Engineers
Quality Management
Analytical Services
Regulatory Affairs and CMC personnel

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