Designing and Sustaining New and Existing Product Stability Testing Program

ComplianceOnline, San Diego, CA
2019-03-07

This seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program. This program is an important part of a product's regulatory filing requirements as well as the determination of the shelf life or expiration date of the product. This is an important part of every business final bottom line or indirectly relationship to their supply and warehouse chain (how long the product can be stored before it can be discarded). Understanding how to design and implement an effective stability testing program following the regulatory guidelines will allow the product to be manufactured, tested, released, adequately stored and effectively tested for stability and ultimately used through its actual end point based on the product's potency. This will eliminate potential loss of product and business income by manufacturers of product (i.e. when a potent product is inadvertently discarded due to a poorly designed stability testing program) which ends up impacting the products' regulatory filing status or a product's Regulatory Filing/Application. The focus of this seminar will create a detailed process that will guide the attendees in the right direction in the planning of a new or existing product's stability testing plan, program, protocol, handing and utilizing the data, setting the shelf life as well as the applicable regulatory requirements.

Learning Objectives:

This seminar will help the attendee gain a better understanding of the requirements of the FDA’s Drug Stability Guidelines that is stipulated for new, existing and modified drug products that have an existing or new IND or NDA submission.

This seminar will also benefit people within the Pharmaceutical, Biotechnology or Medical Device industries that are currently have a stability testing program but do not know how to maximize the use of their data for extending their product’s expiration dating.

This seminar will provide the detailed requirements applicable to the FDA’s and 21CFR 514.1(b)(5)(x) expectations which states that “an applicant should submit data from stability studies that have been completed as well as information about studies that are underway to substantiate the request for a specific expiration date and provide information on the stability of the drug products” FDA’s Guidance for Industry. For this reason, it is important to have clarity and understanding of how to apply this regulation prior to the initiation of a new product stability testing program which includes the protocol design, testing, storage, data management, trending and expiration dating extrapolations and expectations for products in a new or existing IND or NDA application process.

 Who will Benefit:

The Seminar will benefit people within the pharmaceutical, biotechnology or medical device industries that currently have a stability testing program but are not savvy about maximizing the use of their data for extending their product’s expiration dating. The employees who will benefit most include:

• Quality Control Analyst and Management
• Senior Management
• Manufacturing Associates and Management
• Shipping and Distribution Personnel
• Stability Testing Department Personnel and Management
• Regulatory Affairs
• Quality Assurance Analyst and Management
• Process Design Personnel and Management
• Drug Packaging Personnel and Management

Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.

She has been a much sought after SME 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 other regulatory bodies’ inspectional findings. Her remediation work has constantly resulted in several successful national and international regulatory bodies’ inspections, re-inspections and new product approvals.

Her technical expertise covers and goes beyond 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.

She has a keen working knowledge of 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.

She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.