ComplianceOnline, Virtual Training Through WebEx
14/6/21
DAY 01(9:00 AM TO 4:00 PM EDT) - Session 1: 9:00 am – 10:15 am
- Topic: General Stability Considerations Applicable to a Product’s Stability (I.e. Potency), Storage Conditions, Sampling Plan and Sample Handling
- Knowledge Base: Attendees will gain an understanding in the following key areas:
- Introduction of a Stability Testing Plan and Program.
- Regulatory guidance associated with the requirements of a product’s stability testing program.
- Delineating the program requirement specific to a type of product.
- Applicable Regulation and Requirements.
- Purpose of a Stability testing Program
- General Stability Considerations applicable to a New product (I.e. Potency)
- New product stability indicator tests
- Rationale for choosing the test and impact to the product’s shelf life.
- Storage Conditions
- Shelf Life Duration of Studies and Expiration Dates
- Container Closure Requirements
- Session 2: 10:15 am - 11:00 am
- Sample Size
- Sampling Plan
- Handling and Analysis of Samples
- Stability Schedule (Suggested Schedules for Conducting Stability Studies)
- Pre-approval and Post Approval Studies
- Stability Tests
- Reformulated Products
- Accelerated Temperature Studies
- Test Schedule Information
- Suggested Time Points and Expiration dates based on testing time points
- Solid Dosage Forms Suggested Test Schedule
- Liquid and Semi-solid Types Products Suggested Test Schedule
- Reconstituted Products Suggested Test Schedule
- 11:00 am – 11:15 am (Break)
- Session 3: 11:15 am - 12: 00 pm
- The relationship between choosing the right product storage temperature and impact to its shelf life.
- Temperatures of Studies based on the product type
- Room Temperature Studies
- Elevated Temperature
- Refrigeration
- Freezing Temperature
- Special Humidity Considerations
- Container Closure Requirements.
- Storage Temperature for various types of products.
- Performing an effective sampling plan and utilizing the appropriate sample size for a stability testing program.
- Performing a compliant sample analysis, handling and effecting the appropriate test specification for the product type.
- 12:00 pm - 1:00 pm (Lunch Break)
- Session 4: 1.00 pm - 2: 00 pm
- Topic: Designing and Conducting Effective Stability Testing Program Using the Suggested Schedules for Various Product Types
- Knowledge Base: Attendees will gain an understanding in the following key areas:
- How to Conduct a Pre-approval and Post Approval Stability Testing Studies
- Performing Various Types of Stability Tests such as Reformulated Products, Accelerated Temperature Studies and others.
- Understanding the different Types of Stability Test Schedules Provided by Regulations Based on the following Product Types and Information:
- Session 5: 2.00 pm - 3: 00 pm
- Suggested Time Points and Expiration dates based on testing time points
- Solid Dosage Forms Suggested Test Schedule
- Liquid and Semi-solid Types Products Suggested Test Schedule
- Reconstituted Products Suggested Test Schedule
- Performing Different Temperatures of Studies based on the product type such as Room Temperature Studies, Elevated Temperature, Refrigeration, Freezing Temperature and Special Humidity Considerations
- 3.00 pm - 3:15 pm (Break)
- 3.15 pm - 4:00 pm (Review of Case Studies)
- Review of Case Studies: Issues Encountered by Drug Product Manufacturers Based on a Poorly Designed Stability Testing Program
1. Case Study #1 and Suggested Resolution
DAY 02(9:00 AM TO 4:00 PM EDT) - Session 1: 9:00 am – 10:15 am
- Topic: Stability Testing Protocol Design, Data Management and Trending. Comparative Analysis of Using a Manual versus Automated Data Management
- Knowledge Base: The Attendees will gain an understanding in the following key areas:
- How to Design an effective Stability Testing Program, Protocol and a Report for a New and Existing Product.
- How to Effectively Handle, Manage Data, Utilize and Perform the Trending of Stability Testing Results and Data.
- Session 2: 10:15 am - 11: 00 am
- Topic: Analytical Testing Considerations, Review of Case Studies
- Knowledge Base: Attendees will gain an understanding in the following key areas:
- How to perform Quality Control Testing, Setting Test Specification and Assay Release Process in a Stability Testing Program.
- Detailed Reasons why the Choice of a Quality Control Test Method, Specific Assays and Tests Specifications are Critical to the Success of a Product’s Stability Testing Program and Shelf Life Determination.
- Choice of methods with meaningful data or stability indicator
- Analytical Assay Test Method Attributes
- 11:00 am – 11:15 am (Break)
- Session 3: 11:15 am - 12: 00 pm
- Using the Laboratory Information Management Systems (LIMS) in a Stability Study Program
- Data Documentation, Entry and Management (Types of Documentation Methods)
- The Criticality of the Choice of a Stability Test Data Management System used for Data Management.
- Considerations when choosing a Stability Test Data Management System (Manual versus Automated Data Management)
- Advantages and Disadvantages of each type of system
- Types of Stability Test Data Management Software (LIMS) for Stability Test Data Management
- 12:00 pm - 1:00 pm (Lunch Break)
- Session 4: 1:00 pm - 2: 00 pm
- Understanding the LIMS Stability Module Program and Statistical Analysis Tools
- Understanding the various modules under the Stability Data Management Software in LIMS.
- Best practices when selecting Stability test data (LIMS) Vendor
- The various parts of the Stability test data management software
- Common mistakes made during the purchase of some Stability data management software.
- Choosing the best LIMS software programs used for stability test data management.
- Session 5: 2:00 pm - 3:00 pm
- Using Stability Testing Data to Generate the Product’s Expiration Dating or Shelf Life.
- How to Perform the Extrapolation of a Product Shelf Life Using Data from an Ongoing Stability Testing Program
- Great for products in clinical studies.
- Understand the different ways of performing statistical analysis of the stability test result data (manual versus automated software).
- 3:00 pm - 3:15 pm (Break)
- 3:15 pm - 4:00 pm (Review of Case Studies)
- Review of Case Studies: Issues Encountered by Drug Product Manufacturers Based on a Poorly Designed Stability Testing Program
1. Case Study #2 and Suggested Resolution
2. Case Study #3 and Suggested Resolution
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Invited Speakers:
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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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