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Upcoming Webinars

THE BACTERIAL ENDOTOXINS TEST (ISSUES AND SOLUTIONS) TO INCLUDE THE ISSUE OF LOW ENDOTOXIN RECOVERY (LER) AND TR 82 (PDA) AND GENERAL INFORMATION CHAPTER <1085>
TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE (NEW USP<1222>, November 2019) AND ITS RELATIONSHIP TO THE NEW BRITISH TERMINAL STERILIZATION METHODOLOGY (March 2019)
SOLVING STATISTICAL MYSTERIES – WHAT DOES THE FDA WANT?
Best Practices for Deviation Investigations
Annual Laboratory Microbiology Training
A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom
Effective Regulatory Inspections
Development of a Steam Autoclave Sterilization Validation Plan
MICROBIOLOGY FOR THE NON-MICROBIOLOGIST – AND THE MICROBIOLOGIST WHO DESIRES A GMP MICROBIOLOGICAL REFRESHER
How to Detect Lack of Data Integrity
Pharmaceutical Compressed Air – Quality GMP Standards and Requirements
VALIDATION MASTER PLANNING (DEVELOPING A COMPREHENSIVE VALIDATION PACKAGE)
Effective Batch Record Review
Risk Management of Raw Materials in a GMP Environment
Good Laboratory Practices (GLP) vs. Good Manufacturing Practices (GMPs) — A Comparison and Contrast – “Why One Should Use Only GMP Facilities for Manufacturing and Testing”
Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter

ECC Calendar

Apr 2024

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CAPA/Root Cause Analysis: Achieving Compliance with Proper CAPA Systems

Best Practices for Deviation Investigations

Pass Thru Decon and Disinfectant Field Trials

HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms

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

Quality System Management Effectiveness

THE BACTERIAL ENDOTOXINS TEST (ISSUES AND SOLUTIONS) TO INCLUDE THE ISSUE OF LOW ENDOTOXIN RECOVERY (LER) AND TR 82 (PDA) AND GENERAL INFORMATION CHAPTER <1085>

TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE (NEW USP<1222>, November 2019) AND ITS RELATIONSHIP TO THE NEW BRITISH TERMINAL STERILIZATION METHODOLOGY (March 2019)

SOLVING STATISTICAL MYSTERIES – WHAT DOES THE FDA WANT?

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