Is Your Environmental Monitoring Program Risk-Based?

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Tuesday, January 9, 2018 
11:30  – 1:00 pm EST

Instructor:  Marsha Steed (Hardiman)

Non-viable air and viable air and surface monitoring of controlled environments is not a new concept and has been a regulatory requirement for many years. In the past, many companies selected Environmental Monitoring (EM) sample locations based on a grid approach of dividing up the rooms and taking samples inside all of the grids.  Current regulatory requirements involve taking risk based approaches in the manufacturing of products, including Environmental Monitoring.  Does your current EM Program consist of many floor and wall sample locations?  Do you ever ask yourself if the data you are collecting every week/month/year in your EM Program is value added?

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QUALITY METRICS AND THE ISSUES WITH THE FDAs DRAFT GUIDANCE QUALITY METRICS

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Thursday, January 11, 2018
NOON – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

The FDA Safety and Innovation Act (FDASIA) of 2012 provides a firm the legal basis for setting clear 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.  This following DRAFT Guidance represents a follow-up to FDASIA.

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Risk Management of Raw Materials in a GMP Environment

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Thursday, January 18, 2018
NOON – 1:30 pm EST

Instructor:  Barry A. Friedman, Ph.D.

Risk management of raw materials in a GMP environment is an area that is often overlooked as a Company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty raw materials or as many as sixty need to be sourced and accepted before the process can be moved from initiation through completion. This live, interactive presentation will extensively review this area. It will also delve into the renewed issue of microbial and endotoxin contamination of these raw materials and why the FDA, EMA and Health Canada have recently focused on them.

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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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