Scheduled Training Courses

Training NameSpeakerTraining LevelTraining Options 
3-hr Virtual Seminar: Developing Documents and Records to Meet the Requirements of ISO/IEC 17025 Michael Brodsky Advanced
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3-hr Virtual Seminar: Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing Henry Urbach Intermediate
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Objectionable Microorganisms Considering the Risk Henry Urbach Intermediate
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Reducing Drug and Device Batch Release Times: Improving your BPR/DHR Review and Assessment Jerry Dalfors Intermediate
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Environmental Monitoring Program for Contamination Control Carl Patterson Intermediate
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Auditing of Biopharmaceutical Manufacturing Facilities for Microbial Contamination Henry Urbach Intermediate
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Creating Effective and FDA-compliant CGMP Training Program Henry Urbach Intermediate
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Importance of Environmental Monitoring in a Contamination Controlling Plan Erika L. Roberts, M.F.S Intermediate
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SOPs for Bioanalytical Methods Validation Todd Graham Intermediate
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Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance Brian Kirk Intermediate
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Aseptic Processing & Aseptic Techniques Carl Patterson Intermediate
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Vendor Qualification for Quality Services Todd Graham Intermediate
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Validation of Cell Based Assays Dr. Michael Simonian Intermediate
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Serialization Validation; Get Ready for Compliance Driven Actions for the year 2016 & 2017. Herman Bozenhardt Intermediate
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Transitioning Assays from Different Technologies: Validation and Qualification Todd Graham Intermediate
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21 CFR 11 Compliance for Excel Spreadsheet Angela Bazigos Intermediate
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Aseptic Facility Design for Compliance, the Do’s and Don’ts of Building a Facility in 2016 Herman Bozenhardt Intermediate
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Methods for Detecting Mycoplasma Contamination in the Manufacture of Pharmaceuticals and Biologics Dr. Michael Simonian Intermediate
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Bio-analytical Method Validation Edward O’Connor Intermediate
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Container Closure Systems for Liquid and Lyophilized Products J. Jeff Schwegman, Ph.D. Intermediate
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Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing Henry Urbach Intermediate
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Electronic Records and Electronic Signatures: 21 CFR Part 11,Basic Concepts Angela Bazigos Intermediate
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cGMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products Janet Rose Rea Intermediate
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An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (“HCT/Ps”) including Stem Cell-Based Drug Products for Human Use Karl M. Nobert Intermediate
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