Designing and Sustaining New and Existing Product Stability Testing Program: 2-day In-person Seminar

By: Charity Ogunsanya, CEO and Founder, Pharmabiodevice Consulting LLC
Location :- Philadelphia, PA | Thursday, September 26, 2019 | Friday, September 27, 2019

We need the below information to serve you better

Course Description:

New or existing modified drug Stability Testing Program’s regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, some manufacturers of new drug products have made inadvertent mistakes in the design of their new drug stability testing program. Such mistakes may ultimately delay the new, existing or modified product IND or NDA application process due to the data that was presented to the FDA (i.e. Relevant aspects of the stability testing program requirement may have been omitted by the drug manufacturers). It is better to understand, follow and apply the full requirements of a new product stability testing requirement from the onset or to correct an existing stability testing program so as to avoid future pitfalls and delayed IND or NDA submission process by the FDA. Having produced a new or existing product, knowing the appropriate way to design and perform the stability testing of the new product which is a prerequisite for setting the product’s expiration date and possible extension of the expiration date is critical. Some drug product manufacturers have made mistakes in the past whereby a new product that was manufactured appropriately did not have a good stability testing plan or program hence it delayed the product’s ability to have an approved IND or NDA submission. A mistake of this sort has also been made by drug manufactures that resulted in a 483 or Warning letter by the FDA. Knowing how to approach the design of a new product stability program at the onset of the new product design or during an existing product testing is important and will save a company time and cost in moving the product to the next phase.

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

Course Outline

Day One (8:00 AM – 5:00 PM)

8:00 – 9:00 AM: Breakfast and Registration

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

4.00 pm - 5:00 pm (Questions and Answer Session)

5:00 pm (Close of Seminar)

Day TWo (8:00 AM – 5:00 PM)

8:00 – 9:00 AM: Breakfast and Registration

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

4.00 pm - 5:00 pm (Questions and Answer Session)

5:00 pm (Close of Seminar)

Meet Your Instructor

Charity_Ogunsanya _90_112
Charity Ogunsanya,
CEO and Founder, Pharmabiodevice Consulting LLC

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.

Venue

Location :
Philadelphia, PA (Venue to be announced shortly)

September 26-27, 2019
Register Online

Register Online

$1,499

Seminar One Registration

September 26-27, 2019, Philadelphia, PA
(Registrations till August 19, 2019 - $1499)
(Registrations after August 19, 2019 - $1899)

Your registration fee includes the workshop, all course materials and lunch.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965

Download Registration Form

Yes, I want to attend "Designing and Sustaining New and Existing Product Stability Testing Program: 2-day In-person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2479 East Bayshore Road, Suite 260
Palo Alto, CA 94303
USA

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ editor@complianceonline.com

Payment:

Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:

After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions of Philadelphia, PA:

Philadelphia Museum of Art
The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit. Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.

Valley Forge National Historical Park
With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.

The Liberty Bell Center
The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.

National Constitution Center
The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”

The Franklin Institute
An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space. Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.