Why Should You Attend:
This 90-minute training will guide a drug product manufacturer with effectively designing, validation and maintaining a new or existing water system. The appropriate design planning considerations, validation, types of routine tests, testing frequencies, water system maintenance and how to set an acceptable alert and action levels will be reviewed. Water test result/data management and trending which will be a guide to a steady state of control of the different water systems will be presented. This will benefit the manufacturers by helping to avoid future costly pharmaceutical water systems failure, investigations or inability to validate or achieve passing test results from a new or existing water systems emanating from design-related issues..
Agenda
Areas Covered in the Webinar:Module 1:
- Introduction to current USP < 1213> Pharmaceutical Water System
- Scope of the Different Water Systems
- Planning the Design of a Water System
- Planning the Validation of a Water System
Module 2:
- Routine Testing Types Associated with Water Testing Systems
- Non-routine Water Testing Program
- Defining the Water Testing Specifications
- Standard/General Practices for the Collection of Water Samples
- Testing Time Frame
Module 3:
- Water System Failures and Investigation
- Water System(s) re-certification procedure
- Water Testing Data Management and Trending
- Data Trending of Routine Water Testing
Speakers
Charity Ogunsanya has over 26 years of extensive experience within the Pharmaceutical, Biotechnology, Biologics, Cell-Therapy, Diagnostics, Research and Development, Radio-pharmaceutical, Contract Manufacturing Organization (CMO) and Medical Device companies.Throughout her corporate career within these diverse industries, she held various high visibility and business critical roles within the Quality and Compliance division in major Fortune 100 companies both as a Subject Matter Expert (SME), Site Manager, Multi-site Manager and Director Levels receptively. She has been a sought after expert and have been consistently hired after several competitive efforts by major fortune 100 companies to assume key roles specifically related to remediation and difficult Quality and Compliance related deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and difficult regulatory bodies inspectional findings which is always achieved with a successful outcome. She has also been a sought after expert by various companies requesting her expertise as a known industry expert to specifically assume roles in order to perform a total overhaul, restructure, compliance remediation, re-organization, start-up processes related to Quality Systems improvements and/or enhancements. In all cases, her remediation work resulted in several successful National and International regulatory bodies’ inspections, re-inspection and new product approvals.
Her technical expertise are not limited to the interpretation, administration and set up of Quality Assurance, Quality/Compliance, Quality Engineering, Aseptic Processing, Contamination Control, Quality Control, Microbiology, Sterility Assurance, Stability, Vaccine Development, New Product Design, Product Release Testing and Medical Device Sterilization (Ethylene Oxide (EtO), Gamma, Radiation, VHP sterilization) systems and operations for compliance to various regulations.
Ms. Ogunsanya is vast in the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections. Her expertise has been sought after by several Fortune 100 Pharmaceutical, Biotechnology, Biologics and Medical Device companies as a Quality and Compliance SME during critical national and international regulatory bodies’ routine and new product approval inspections.
She is the CEO of Pharmabiodevice Consulting LLC (www.pharmabiodeviceconsultant.com) targeted towards Quality and Compliance related remediation, enhancements and consultant services for various companies within the industry. She is a well sought after high level consultant for several international professional expert networks such as Gerson Lehrman Group, Zintro Expert Network and Intota Expert Network. She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network.
Who Should Attend
This training will be beneficial to professionals in the Pharmaceutical, Cell Therapy, Diagnostics, Biologics, Biotechnology and Medical Device Industries. The employees who will benefit most include personnel and management within:
- Quality Control Analyst
- Manufacturing Associates
- Facility and Utility
- Quality Assurance Analyst
- Vendors and Suppliers of Pharmaceutical Water Systems and Peripherals
- Regulatory Affairs
- Shipping and Receiving
- Materials Handling
- Supplier Quality
