The Pharmaceutical Quality System (PQS) is the key system evaluated during FDA and global inspections. The development of a robust Pharmaceutical Quality System (PQS), as defined in the ICH guidance document Q10, "Pharmaceutical Quality System", is an internationally-harmonized guidance document that provides a model for establishing a PQS and applies to the development and manufacture of pharmaceutical drug substances ((i.e. active pharmaceutical ingredients (APIs)) and drug products, including biotechnology and biological products) and applies throughout the lifecycle of the product.
The foundation of ICH Q10 is Regional GMPs, ISO (International Organization for Standardization) quality management system guidelines and the ICH guidance document Q7, "Good Manufacturing Practices for Active Pharmaceutical Ingredients". Although regional GMPs make up part of the foundation of the ICH Q10 guidance, "Pharmaceutical Quality System", in that ICH Q10 augments regional GMPs by describing specific quality system elements and management responsibilities, the ICH Q10 guidance document is intended to be used together with regional GMP requirements.
Two additional ICH guidance documents, ICH Q8, "Pharmaceutical Development" and ICH Q9, "Quality Risk Management", compliment the ICH Q10 guidance document in establishing a PQS.
Learning Objectives:
- Requirements for establishing a robust Pharmaceutical Quality System (PQS), per ICH Q10, in order to avoid inspectional observations
- How the elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages
- Requirements of Quality Management as far as establishing and maintenance of an effective PQS, escalation to upper management, definition of roles and responsibilities in regards to the PQS, appropriate documentation that has to be created, as well as reviewed for an effective PQS
- All aspects of establishing a pharmaceutical quality system per Q10 will be covered, including lifecycle stages, the documents used to create ICH Q10 PQS, including GMPs and ISO documents, PQS elements, design of PQS, enablers, and objectives of ICH Q10, in order to understand all aspects of creating an effective PQS
- The objectives of the ICH Q10 guidance, including achieving product realization, establishing and maintaining a state of control and facilitating continual improvement throughout the stages of the product lifecycle (Pharmaceutical Development, Technology Transfer, Commercial Manufacturing and the Product Discontinuation stages) will be covered
- Enablers, which are the tools or processes used to establish the PQS objectives will also be discussed/defined
- The Four Elements of a Pharmaceutical Quality System, including the Process Performance and Product Quality Monitoring system, the Corrective and Preventive Action (CAPA) system, the Change Management System and the system for Management review of Process Performance and Product Quality will also be discussed in detail
- Obtaining a level of product and process understanding, along with demonstration of an effective PQS, including the use of quality risk management principles (e.g., ICH Q8, ICH Q9 and ICH Q10) and how this may present "potential opportunities" as far as regulatory approaches will be briefly discussed, as listed in the ICH Q10 document
Why Should You Attend:
Attend this training to Understand the responsibilities of quality management in establishing an effective PQS (Pharmaceutical Quality System) in terms of design, maintenance and monitoring, an escalation process, defining of roles and responsibilities, data to be reviewed by management, as well as issues related to establishing Quality Policy, Quality Planning, Resource Management, Internal Communication, Management Review, Management of Outsourced Activities and Purchased Materials.
Instructor
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, biopharmaceutical, medical device, combination drug/device and nutraceutical firms.
Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical and biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, post-marketing supplements such as CBEs, Prior approval supplements, orphan drug submissions, 510ks, PMAs and HDEs).
She also has extensive QA and validation experience, successfully hosting many compliance audits conducted by FDA, ISO and other international regulatory bodies, as well as 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 (CAPA, Change Control, Complaint handling, Document Control systems), stability programs, as well as preparation/performance of process validation(s), sterilization validation(s) (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems and qualification of equipment.
Stephanie has been involved in the development of drugs and devices, from product concept through post-approval maintenance and is experienced in the formulation or design of new drugs or devices, establishing required preclinical and clinical testing necessary, Regulatory and Quality Requirements, including requirements for submission, process validation, etc. and has considerable project management experience.
Stephanie worked for Scīele Pharma from 2005-2009 and was VP of Regulatory Affairs, Quality Assurance/Validation for Scīele, prior to leaving in 2009 to start Cooke Consulting. 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.