New York Professional Events List

Designing A Pharmaceutical Quality System (ntz)

Apr 26, 2018 - 09:00 AM - Apr 27, 06:00 PM
16038, West Vly

Highway Tukwila,
ZIP: 98188

DESIGNING A PHARMACEUTICAL QUALITY SYSTEM: An in-depth examination of ICH Q10 and the companion documents (ICH Q8, Pharmaceutical Development and ICH Q9, Quality Risk Management), in order to establish a robust, globally-required Pharmaceutical Quality System

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

Day 1 Schedule

Lecture 1:

Brief overview of ICH-30 minutes, description of the Pharmaceutical Quality System, per Q10, including objectives, background, enablers, definition of stages of Product Lifecycle and what activities constitute each stage.

Lecture 2:

Continue Review of Pharmaceutical Quality System, including elements, such as CAPA, Change Management, Process Performance and Product Quality Monitoring System, and Management Review of Process Performance and Product Quality.

Lecture 3:

Continue review of Pharmaceutical Quality System, including review of application/use of ICH Q10 pqs elements and Management responsibilities and encouraging the use of Science and Risk-based approaches at each lifecycle stage.

Lecture 4:

Examples of application of elements across the Lifecycle of the Product. Also, use of the Companion Documents, as ICH Q10 was designed to be used with ICH Q8, product development and ICH Q9, Quality Risk Management and talk about how they operate together.

Day 2 Schedule

Lecture 1:

Brief overview of ICH Q7, GMPS for APIs. Discussion of ICH Q11, Development and Manufacture of Drug Substances (Chemical entities and Biotechnological/Biological entities).

Lecture 2:

Discussion of ICH Q8, Pharmaceutical Development, including traditional and enhanced approaches to development, establishing Manufacturing process, Process parameters, introduction to Quality Risk Management for Product and Process Development. Will discuss both Drugs from Chemical entitites as well as Biotechnological/Biological entities.

Lecture 3:

More discussion of Quality Risk Management and relation of how to use these 3 documents for a Pharmaceutical Quality System (as ICH intended them to be used). Discussion of design space.

Lecture 4:

More discussion of design space, and establishing in regulatory filing (existing and new products) and the regulatory benefits of establishing a PQS, in conjunction with ICH Q8, and Q9, regulatory benefits of establishing a design space, as far as post-approval filings, and benefits of establishing and maintaining a Pharmaceutical Quality System across Product Lifecycle and benefits as far as Risk Based Regulatory Audits, etc.


Stephanie Cooke

President/CEO, Cooke Consulting Inc. 

Stephanie Cooke, is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms. Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical (chemical entities and biologically-based drugs), biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, BLAs, post-marketing supplements such as CBEs, Prior approval supplements, orphan drug designation and related submissions, 510ks, PMAs and HDEs). She also has extensive QA and validation experience, successfully hosting many regulatory audits conducted by FDA, ISO and other international regulatory bodies (Irish Medical Board and others), training personnel on hosting audits by global regulatory bodies, as well as establishing auditing programs to qualify contract manufacturers and vendors of raw materials, APIs, etc. and product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for establishing and maintaining Quality systems for all product types, establishing stability programs, as well as preparation/performance of process validation(s), including sterilization validation(s) (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems and manufacturing process validation. Stephanie has been involved in the development of drugs, including biologics, biotech products and medical devices, from product concept through post-approval maintenance including requirements for submissions for various regions/countries, process validation requirements, etc. and has considerable project management experience. Ms. Cooke is experienced the development of APIs, drug products (including biological/biotech products and their associated manufacturing processes. In addition, she has had much experience working on CMC sections of the CTD for various countries/regions, establishing required preclinical and clinical testing necessary for regulatory filings, as well as preparing the information for regulatory submissions. Prior to beginning Cooke Consulting, Inc.about 9 years ago, Stephanie worked for Sciele¬ Pharma from 2005-2009 as the VP of Regulatory Affairs, Quality Assurance/Validation. She also held various senior RA, QA and validation positions at Merial, Bayer (Visible Genetics), Cryolife, Theragenics and other pharmaceutical, biotech and medical device companies, after beginning in industry as a lab tech and working as a certified as a Microbiologist. She has a BS in Biology and an M.S. in Molecular Genetics and Biochemistry from Georgia State University.

Please contact the event manager Marilyn (marilyn.b.turner(at) ) below for: 
- Multiple participant discounts 
- Price quotations or visa invitation letters 
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc) 
- Event sponsorship 

Prices may go up any time. Service fees included in pricing. 
This event is brought to you by: 
NTZ - NewYorkEventsList 

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Event Categories
Keywords: fun, biology , Clinical , design , Designing, development , environment, Fun , history , histor


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