Quality Metrics and Risk Based Inspections

FDA’s Request for Quality Metrics (New Proposed Guidance July 2015) and Its Basis – The FDA’s Safety and Innovation Act (FDASIA)

A Live, Interactive Training Webinar; See: http://www.tungstenshield.com/barry-a-friedman-phd/

Date: Tuesday August 18, 2015 Time: 9:30 – 11:30 AM ET (New York Time) Instructor: Barry A.Friedman Ph.D.

Quality Metrics and Risk Based Inspections is a topic often “tossed around”. But what does it mean to the manufacturer within the pharmaceutical/ biotechnology arena? Each year the FDA and CDER, in particular, issue a variety of the most frequent Observations that they encounter and summarize them according to their frequency. Interestingly, even though Industry can readily view this list and various members of the CDER organization speak about them at numerous conferences, seminars and on-line, the list continues to exist, and the numbers of Observation occurrences is not diminished. When asked why the list does not “go away”, comments such as ‘the list does not apply to our Company” to “we don’t understand the Observations” are often heard. These flippant comments from various Companies only perpetuate additional Observations.

The FDA Safety and Innovation Act (FDASIA) of 2012 provides a firm legal basis for setting clearer standards and for collecting data to assess manufacturing operations. Section 705 of FDASIA requires FDA to establish a risk based schedule for inspecting drug manufacturing sites, and requires access to more detailed information on facilities and quality controls. Section 706 authorizes the Agency to obtain information on drug production sites and operations in advance of an inspection. Together, these two Sections support FDA’s strategy for improving how it assesses the ability of a manufacturing site to consistently produce medicines fit for intended use.

FDA understands that establishments involved in the manufacture, preparation, propagation, or processing of human drugs, including oversight to ensure quality, currently use quality metrics as part of the process validation lifecycle and pharmaceutical quality system (PQS) assessment. This new, proposed guidance outlines FDA’s authority to require owners and operators of such establishments to provide upon request records and information that FDA may inspect under section 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act, or the Act), and describes an initial set of requests the Agency intends to make to certain owners and operators. FDA intends to make its requests at the time this guidance is finalized, and to provide notice in the Federal Register.

This live training webinar will discuss the just issued DRAFT Guidance for Industry on “Request for Quality Metrics” along with how FDASIA is pushing it forward, review the most common Citations issued during the past several years, dissect each resultant Observation, explain the rationale behind them and present actual examples of Form FDA 483s and Warning Letters that include that particular Observation. A total of approximately 15 sections within CDER’s CFRs from each year will be examined in detail and their frequency compared against previous years.

This webinar is especially valuable to not only those within the Quality area of your Company, but also within other Departments to include Incoming Raw Materials, Manufacturing and Facilities. Because of the sensitivity and importance of understanding Quality Metrics, this live training webinar is a MUST for anyone in your organization that is involved in the management of, or recipients of Regulatory actions.