Quality Metrics and Risk Based Inspections; FDA’s New November 2016 DRAFT "Submission of Quality Metrics Data” & Safety and Innovation Act (FDASIA)

Live, Interactive Training Webinar

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Instructor: Barry A.Friedman Ph.D. Biography>>>

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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. This revised draft guidance includes an 23 explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for 24 Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics 25 to help ensure that their policies and practices continue to support continuous improvement and 26 innovation in the pharmaceutical manufacturing industry. 27 In order to achieve these goals, FDA is initiating a quality metrics reporting program.3 28 As

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, revised, 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 (November 2016) DRAFT Guidance for Industry on “Submission of Quality Metrics Data” and how the FDA intends to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement 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.

Learning Benefits:
- Learn about the new proposed “Request for Quality Metrics” and its Relationship to FDASIA
- Understand the Requirements of the FDA’s Request to Industry
- Determine how the Draft Relates to Most Frequent Citations from 21 CFR 210/211
- Learn of the Most Frequent Citations from within the 21 CFR 210/211 Code of Federal Regulations (CFR)
- Review of the Past Several Years’ Overall Major Citations and how They may Impact your Organization
- Hear the Rationale Behind an Observation and why the Underlying “Citation” was Cited
- Comparison of Citations against Observations within Warning Letters
- Interpretation of the Results
- Review of Pertinent Form FDA 483s and Warning Letters

Webinar outline and time breakdown:

9:15 AM Log In Period
9:30 AM Introduction
9:40 PM Definitions,
FDA’s Request for Quality Metrics and What it Involves,
Most Frequent Citations over Past Several Years,
Rankings of Citations and the FDA’s Rationale,
Comparison of Citations vs. Resultant Observations,
10:30 AM Break
10:40 AM Interpretation of Various Observations,
Understanding TurboEIR,
Why Various Citations are Offered Versus Others,
Review of Pertinent Form FDA 483s and Warning Letters,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Manufacturing
  • Regulatory Affairs Professionals
  • Facilities/li>
  • Those that use contract manufacturing and contract testing facilities

Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>



Course Number: 243

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

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"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

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