Aseptic Processing Necessities

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Tuesday, January 23, 2018
 11:30  – 1:00 pm EST

Instructor:  Marsha Steed (Hardiman)

Manufacturing of pharmaceutical, biopharmaceutical or medical device products via aseptic processing requires knowledge and understanding of the basic principles of Microbiology in order to manage the aseptic operations and produce sterile products. Lack of understanding about good aseptic technique, proper facility design, adequate cleaning and correct cleanroom behaviors can lead to contamination of product, time consuming investigations and rejection of production batches.  In this course we will discuss:

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UNDERSTANDING THE BACTERIAL ENDOTOXIN TEST TO INCLUDE THE ISSUE OF LOW ENDOTOXIN RECOVERY (LER)

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Thursday, January 25, 2018

NOON – 1:30 pm EST

Instructor:  Barry A. Friedman, Ph.D.

On Tuesday, July 12, 2011, the FDA posted on their web site a notice that they had withdrawn the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human Parenteral Drugs, Biological Products and Medical Devices.  They advised that the 1987 Guideline is considered obsolete and does not reflect the Agency’s current thinking on the topic.

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The Microbiology of Water in a GMP Environment

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Tuesday, January 30, 2018
NOON – 1:30 pm EST

Instructor:  Barry A. Friedman, Ph.D.

Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility revolves around the health of each water system within that facility. How often have we learned of a facility being closed for weeks at a time because of a water system that has exceeded its microbiological specifications?

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Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment

Tuesday, February 6, 2018
 12:00 Noon – 1:30 pm EST

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Instructor:  Jim Polarine

This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.

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Robust and Risk-Based Media Fill Programs

Thursday, February 8, 2018
  12:00 Noon – 1:30 pm EST

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Instructor:  Marsha Steed (Hardiman)

The Aseptic Process Simulation (APS), which is commonly referred to as the Media Fill, is a critical piece in the aseptic manufacturing of sterile pharmaceutical and medical device products. Verification of the aseptic manufacturing process to produce sterile products is performed by simulating the manufacturing process with media.

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USP/FDA Microbiological Non-Compliance Issues in a Bipharmaceutical/Pharmaceutical Environment

Thursday, February 15, 2018
 12:00 Noon  – 1:30 pm EST

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Instructor:  Barry A. Friedman, Ph.D.

USP/FDA Microbiological Non-Compliance Issues represent often observed problems that occur with both non-sterile and sterile products in controlled and classified environments as well as within the microbiological laboratory.  Various regulators will cite firms for these non-compliance issues under a variety of different sections of the Code of Federal Register (CFR) to include 21 CFR 211.113(a) and (b), 211.84(d)(6), 211.165(b), and 211.192.  Non-compliance issues are also cited as per United States Pharmacopeia to include USP<51>, <61>, <62>, <71>, <1072>, <1111>, and <1116>. Also, various Guidances for Industry are also included and often used within citations.  One of the most notable is the September 2004 FDA Guidance for Industry on Aseptic Processing.

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Creating Your Monitoring Plan and Risk Assessment for ISO 14644-1,2

Thursday, February 22, 2018
 12:00 Noon – 1:30 pm EST

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Instructor:  Marsha Steed (Hardiman)
The ISO Standards for cleanrooms and associated controlled environments, ISO 14644-1 Classification of air cleanliness by particle concentration and ISO 14644-2 Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration have been updated and have been effective since 12Dec2015.

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FDA Contract Manufacturing Arrangements for Drugs: Quality Agreements – Their Relationship to Microbiological Issues

Tuesday, February 27, 2018
 12:00 Noon  – 1:30 pm EST

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Instructor:  Barry A. Friedman, Ph.D.

Written Quality Agreements are not explicitly required under existing CGMP regulations and do not relieve either party of their responsibilities under CGMP regulations or under the FD&C Act 501(a)(2)(B). However, Owners and Contracted Facilities can draw on quality management principles to initiate the complicated process of contract drug manufacturing by defining, establishing, and documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support operations. Accordingly, FDA recommends that Owners and Contracted Facilities implement written Quality Agreements as a tool to delineate responsibilities and assure the quality, safety, and effectiveness of drug products.

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