Webinars
Archived ECC Webinars
| ECC # | DATE | TITLE | Instructor(s) |
|---|---|---|---|
| ECC-659 | 2025-01-16 | Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter | Barry A. Friedman Ph.D |
| ECC-658 | 2025-01-15 | Development of a Steam Autoclave Sterilization Validation Plan | Barry A. Friedman Ph.D |
| ECC-662 | 2025-01-14 | How to Develop a Holistic Contamination Control Strategy for ATMP Cleanrooms | Jim Polarine |
| ECC-654 | 2024-12-12 | VALIDATION MASTER PLANNING (DEVELOPING A COMPREHENSIVE VALIDATION PACKAGE) | Barry A. Friedman Ph.D |
| ECC-657 | 2024-12-11 | GMP Environmental Monitoring for Pharmaceutical Clean Rooms | Roger Cowan |
| ECC-656 | 2024-12-10 | Developing a Holistic Disinfectant Validation and Efficacy Testing Program | Jim Polarine |
| ECC-655 | 2024-12-05 | Effective Batch Record Review | Danielle DeLucy |
| ECC-653 | 2024-12-04 | MICROBIOLOGY FOR THE NON-MICROBIOLOGIST – AND THE MICROBIOLOGIST WHO DESIRES A GMP MICROBIOLOGICAL REFRESHER | Barry A. Friedman Ph.D |
| ECC-652 | 2024-12-03 | 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> | Barry A. Friedman Ph.D |
| ECC-648 | 2024-11-21 | Risk Management and The New General Chapter, USP<60>, Burkholderia cepacia | Barry A. Friedman Ph.D |
| ECC-631 | 2024-11-20 | Cleaning Validation Analytical Methods: Frequently Asked Questions | Paul Lopolito,Brian Bosso |
| ECC-647 | 2024-11-19 | Good Laboratory Practices (GLP) vs. Good Manufacturing Practices (GMPs) — A Comparison and Contrast – “Why One Should Use Only GMP Facilities for Manufacturing and Testing” | Barry A. Friedman Ph.D |
| ECC-646 | 2024-11-14 | Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile ProductionFDA and ICH Expectations and Guidance | Barry A. Friedman Ph.D |
| ECC-645 | 2024-11-13 | Risk Management of Raw Materials in a GMP Environment | Barry A. Friedman Ph.D |
| ECC-650 | 2024-11-12 | GMP Environmental Monitoring for Pharmaceutical Clean Rooms | Roger Cowan |
| ECC-649 | 2024-11-07 | Quality System Management Effectiveness | Danielle DeLucy |
| ECC-651 | 2024-11-05 | Hot Topics in the Cleanroom Industry: Biodecontamination of RABS and Isolators, Materials Transfer and Disinfectant Field Trials | Jim Polarine |
| ECC-630 | 2024-10-30 | Establishing Limits for Cleaning Validation | Paul Lopolito,Dijana Hadziselimovic |
| ECC-640 | 2024-10-29 | The Microbiology of Water in a GMP Environment | Barry A. Friedman Ph.D |
| ECC-642 | 2024-10-16 | CAPA/Root Cause Analysis: Achieving Compliance with Proper CAPA Systems | Danielle DeLucy |
| ECC-643 | 2024-10-15 | A Roadmap to a Successful Contamination Control Strategy (CCS): Covering Annex I Updates and FDA Warning Letters and 483’s | Jim Polarine |
| ECC-639 | 2024-10-09 | FDA Contract Manufacturing Arrangements for Drugs: Quality Agreements - Their Relationship to Microbiological Issues | Barry A. Friedman Ph.D |
| ECC-644 | 2024-10-08 | HVAC and GMP Environmental Control – for Pharmaceutical Clean Rooms | Roger Cowan |
| ECC-641 | 2024-10-03 | Investigating OOS results | Danielle DeLucy |
| ECC-638 | 2024-10-02 | Annual Laboratory Microbiology Training | Barry A. Friedman Ph.D |
| ECC-637 | 2024-10-01 | Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter | Barry A. Friedman Ph.D |
| ECC-636 | 2024-09-26 | Process Simulation Testing for Aseptically Filled Products | Barry A. Friedman Ph.D |
| ECC-629 | 2024-09-25 | How to Remediate Microbial Contamination of Process Equipment | Paul Lopolito,Brian Bosso |
| ECC-635 | 2024-09-24 | VALIDATION MASTER PLANNING (DEVELOPING A COMPREHENSIVE VALIDATION PACKAGE) | Barry A. Friedman Ph.D |
| ECC-634 | 2024-09-17 | A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom | Jim Polarine |
| ECC-633 | 2024-09-05 | TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE (NEW USP<1222>, November 2019) AND ITS RELATIONSHIP TO THE NEW BRITISH TERMINAL STERILIZATION METHODOLOGY (March 2019) | Barry A. Friedman Ph.D |
| ECC-632 | 2024-09-04 | Pharmaceutical Compressed Air – Quality GMP Standards and Requirements | Roger Cowan |
| ECC-628 | 2024-08-28 | Derouging and Passivation of Stainless-Steel Equipment | Paul Lopolito,Dijana Hadziselimovic |
| ECC-627 | 2024-08-27 | Risk Management of Raw Materials in a GMP Environment | Barry A. Friedman Ph.D |
| ECC-625 | 2024-08-22 | Effective Batch Record Review | Danielle DeLucy |
| ECC-624 | 2024-08-21 | 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> | Barry A. Friedman Ph.D |
| ECC-626 | 2024-08-15 | Development of a Steam Autoclave Sterilization Validation Plan | Barry A. Friedman Ph.D |
| ECC-622 | 2024-08-13 | Hot Topics in the Cleanroom Industry, Biodecontamination of RABS and Isolators, Materials Transfer and Disinfectant Field Trials | Jim Polarine |
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