3 Must Buy Webinars on Product Stability Testing, Gas Testing and Water Testing Program

This package training will explain in detail, the requirements of the FDA's drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries. It will also provide a great resource to manufacturers and gas suppliers/vendors who are planning a new, existing or modifying an existing gas system so as to meet the requirements of ISO 8573, USP or FDA requirements. Apart from giving insights on pharmaceutical product test and gas testing, this webinar will help the attendee gain an understanding of the requirements of Pharmaceutical Water Systems per current USP <1231> Water for Pharmaceutical Purposes.
Instructor: Charity Ogunsanya
Product ID: PACK70029

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Quality Control Analyst and Management
  • Senior Management
  • Manufacturing Associates and management
  • Shipping and Distribution Personnel
  • Shipping and Receiving Personnel and Management
  • Stability Testing Department Personnel and Management
  • Regulatory Affairs
  • Quality Assurance Analyst and Management
  • Process Design Personnel and Management
  • Drug Packaging Personnel and Management
  • Facility and Utility Personnel and Management
  • Vendors and Suppliers of Pharmaceutical Water Systems and Peripherals
  • Regulatory Affairs and Personnel Management
  • Materials Handling Personnel and Management
  • Supplier Quality Personnel and Management
  • Site Director
  • Operations Director
  • Others

Webinars included in the Package:

Product Stability Testing Program - Designing and Sustaining New and Existing Programs(Duration: 90 Minutes)

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."

Objectives of the Presentation:

  • Introduction of a Stability Testing Plan and Program
  • General stability considerations Applicable to a New Product (i.e. Potency)
  • Storage conditions
  • Sample size
  • Stability schedule (Suggested Schedules for Conducting Stability Studies)
  • Temperatures of studies based on the product type
  • Analytical testing considerations
  • Stability testing protocol design
  • Stability testing data management and trending
  • Manual versus automated data management

Pharmaceutical Gas Testing Program (Duration: 90 Minutes)

This webinar will help the attendee gain an understanding of the requirements of Pharmaceutical Gas Systems per current ISO 8573 Air Testing. Details of how to design, perform routine testing, and utilize the test data from different types of gas systems such as Nitrogen, Argon and Compressed Gases, step-by-step guidance to a product manufacturer that is planning to install, validate and routinely test a new or modified existing gas system so as to comply with the regulations will also be discussed. This course will also cover topics such as how to set the appropriate gas testing frequency, types of testing to be performed, setting the alert and action levels, utilizing the gas testing results, performing data evaluation, data management, data trending, performing failure, contamination, excursion and out-of-specification investigation and remediation and product disposition by the Quality unit.

Objectives of the Presentation:

  • Regulations, types of gases and the routine testing requirements associated with pharmaceutical gases
  • Plan, define, design, and validate a gas system using a compliant validation protocol
  • Different types of tests, testing frequencies, sampling procedures, appropriate test specifications for various types of pharmaceutical gases
  • Types of testing associated with different types of pharmaceutical gases including the allowable limits for each type of test
  • Re-evaluation of an alert or action limit associated with the various types of pharmaceutical gas systems
  • How to perform routine data management and trending of the results from pharmaceutical gases

Pharmaceutical Water Testing Program (Duration: 60 minutes)

This webinar will also guide a drug product manufacturer with a new or existing water system about the appropriate types of routine testing frequency, types of testing as well as how to set an acceptable alert and action levels for the different water systems. This webinar will also cover water test result/data management and trending in order to guide the user about the best way to have a steady state of control of the different water system. This will help the user or manufacturers to avoid future pharmaceutical water failure investigation or inability to validate or get a good test results from the new water system due to design related issues.

Objectives of the Presentation:

  • 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
  • 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
  • Water System failures and investigation
  • Water System(s) re-certification procedure
  • Water Testing data management and trending

Instructor Profile:

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.

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