Product Stability Testing Program - Designing and Sustaining New and Existing Programs

Why Should You Attend:

To avoid mistakes and misinterpretations while designing a new drug stability testing program or while modifying existing ones, it’s best to have a clear knowledge of the regulations and guidelines stipulated by the FDA, 21 CFR and other regulatory bodies.

This session will help the attendee gain a better understanding of the requirements of the FDA’s drug stability guidelines stipulated for new, existing and modified drug products with an existing or new IND or NDA submission.

This webinar will also provide detailed requirements applicable to the FDA 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.” Consequently, 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.

Areas Covered in the Webinar:

1. Introduction of a Stability Testing Plan and Program
1. Applicable Regulation and Requirements
2. General Stability Considerations Applicable to a New Product (i.e. Potency)
3. Storage Conditions
1. Shelf Life Duration of Studies and Expiration Dates
2. Container Closure Requirements
4. Sample Size
1. Sampling Plan
2. Handling and Analysis of Samples
5. Stability Schedule (Suggested Schedules for Conducting Stability Studies)
1. Pre-approval and Post Approval Studies
2. Stability Tests
3. Reformulated Products
4. Accelerated Temperature Studies
5. Test Schedule Information
1. Suggested Time Points and Expiration Dates Based on Testing Time Points
2. Solid Dosage Forms Suggested Test Schedule
3. Liquid and Semi-solid Types Products Suggested Test Schedule
4. Reconstituted Products Suggested Test Schedule
6. Temperatures of Studies Based on the Product Type
1. Room Temperature Studies
2. Elevated Temperature
3. Refrigeration
4. Freezing Temperature
5. Special Humidity Considerations
7. Analytical Testing Considerations
1. Quality Control Release Assays and Methods
2. Criticality of the Choice of Test that are Stability Indicators
1. Choice of Methods with Meaningful Data or Stability Indicator
2. Method Attributes
3. Method Attributes
8. Stability Testing Protocol Design
1. How to Design a Protocol and a Report
9. Stability Testing Data Management and Trending
1. Trending Data
2. Expiration Dating Extrapolation Using Data
10. Manual versus Automated Data Management
1. Advantages and Disadvantages

Who Will Benefit:

The webinar 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
CEO, Laurdan Associates Inc

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.

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