Designing and Sustaining New and Existing Product Stability Testing Program

  • Check with publisher
  • Published date: August 27, 2021
    • san Jose, california, United States

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 Virtual 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.

Result 0 votes
Ashutos Swain
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Investigation of Out-of-Specification Test Results

    Investigation of Out-of-Specification Test Results

    Pharmacology - Drug Development san Jose (california) June 26, 2021 Check with publisher

    Attendees will learn how to streamline and conduct timely OOS and OOT investigations that meet FDA GMP expectations. Responsibility of the Analyst Responsibility of the Supervisor Obvious error Retesting Resampling Result validation Initiation of a p...

  • Human Error Reduction in GMP Manufacturing

    Human Error Reduction in GMP Manufacturing

    Pharmacology - Drug Development san Jose (california) June 25, 2021 Check with publisher

    Human error is known to be the major cause of observations from regulatory agencies, quality deviations, and production losses in many organizations. Although it is unlikely that human error will ever be totally eliminated, many human performance pro...

  • Writing and Revising SOPs for Increased Operational Efficiency

    Writing and Revising SOPs for Increased Operational Efficiency

    Pharmacology - Drug Development san Jose (california) May 24, 2021 Check with publisher

    Are new staff confused during training on your SOPs? Do you have too many SOPs? Do some SOPs give directions that conflict with directions from other SOPs? Are you writing up deviations far too often? Do you have some SOPs that just plainly don’t mak...