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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FDA’s Combination Products and Its Impact on Manufacturers of Pharmaceuticals, Biopharmaceuticals, Medical Devices and HCT/P – The Final Guidance, “Current Good Manufacturing Practice Requirements for Combination Products”

Thursday March 8, 2018
1:30 pm – 3 pm EST

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Instructor:  Barry A. Friedman, Ph.D., LLC 

Historically, the absence of clear cGMP requirements for Combination Products has resulted in inconsistent application as to the applicable Agency Center to submit product for review. Products for both CDER and CDRH as the primary Agency contact point may have historically been submitted to the incorrect organization for review because of a lack of knowledge as to the Primary Mode of Action (PMOA) of the product.

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Exploring the Breadth of Pharmaceutical Microbiological Auditing

Thursday March 15, 2018
1:30 pm – 3 pm EST

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Instructor:  Barry A. Friedman, Ph.D., LLC 

Microbiology plays a role throughout the manufacture of pharmaceutical products.  Whether the final product is non-sterile or sterile, the bioburden exists throughout the process and/or within the product’s environment. A critical review of the overall microbiological process will determine whether the critical “in-process” points permit the final product to meet its acceptance criteria.

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Good Laboratory Practices (GLP) vs. Good Manufacturing Practices (GMPs)

Thursday March 22, 2018
1:30 pm – 3 pm EDT

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Instructor:  Barry A. Friedman, Ph.D., LLC 

A Comparison and Contrast – “Why One Should Use Only GMP Facilities for Manufacturing and Testing”.
Periodically one hears the comment that “a laboratory or a manufacturing facility meets 21 CFR Part 58 Good Laboratory Practices (GLP) and therefore they meet all of the cGMP requirements”.

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KEY ELEMENTS OF A COMPREHENSIVE VALIDATION PLAN

Tuesday March 27, 2018
12:00 Noon – 1:30 pm EDT

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Instructor: Barry A. Friedman, Ph.D., LLC

Whether a Company is developing a new product or facility, the issue of a comprehensive Validation Package is essential to assure the timely completion of all activities. A Validation Package is designed to satisfy both current domestic and international regulations, guidelines and policies for active pharmaceutical ingredients

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Applying Risk to Cleanroom Qualification

Tuesday April 17, 2018
  12:00 Noon – 1:30 pm EST

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Instructor:  Marsha Steed (Hardiman)

Qualification of a cleanroom is a critically important task for any healthcare company manufacturing in controlled environments. There is often a push from management to get the new cleanroom(s) or renovated cleanroom(s) into a state that is ready for production use as soon as possible. The proper balance of compliance and business risk often comes into play.

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