Upcoming Live Training Programs by Barry A. Friedman Ph.D. :

2019 United States Pharmacopeia (USP) Microbiological General and Information Chapters Training Program

7-Part Live Training Program - Instructor: Barry A. Friedman Ph.D.

Part 1: USP <1115> Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter
Live Training Webinar - Date: Tuesday April 2, 2019

Part 2: USP <51> Antimicrobial Effectiveness Testing – A New 2016 Revised Chapter
Live Training Webinar - Date: Thursday April 4, 2019

Part 3: The USP <1113> Microbial Characterization, Identification, and Strain Typing. What it Means to cGMP; Exploring Various Available Methodologies to Characterize and Identify Microorganisms
Live Training Webinar - Date: Tuesday April 30, 2019

Part 4: USP <1072> Disinfectants and Antiseptics - Use and Application of Sanitizers, Disinfectants and Sterilants
Live Training Webinar - Date: Thursday May 2, 2019

Part 5: - USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments and Its Comparison & Contrast to FDA’s Guidance; Aseptic Processing (2004) and Annex 1 (2009)
Live Training Webinar - Date: Tuesday May 28, 2019

Part 6: - USP <71> Sterility Tests; Method, Limitations, Sampling Quantities and Volumes to Conform with United States Pharmacopeia
Live Training Webinar - Thursday May 30, 2019

Part 7: FDA New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices; A Comprehensive Review of the Current Testing Requirements to Include USP <85> Bacterial Endotoxins Test & The USP Microbiology Expert Committee’s Opinion on Low Endotoxin Recovery (LER)
Live Training Webinar - Date: Tuesday June 25, 2019

Detailed 7-Part Live Training Program Agenda>>>


USP <1115> Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter
Live Training Webinar - Date: Tuesday April 2, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


FDA New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices; A Comprehensive Review of the Current Testing Requirements & The USP Microbiology Expert Committee’s Opinion on Low Endotoxin Recovery (LER)
Live Training Webinar - Date: Wednesday April 3, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


USP <51> Antimicrobial Effectiveness Testing – A New 2016 Revised Chapter
Live Training Webinar - Date: Thursday April 4, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Good Laboratory Practices (GLP) – Comparing and Contrasting with Good Manufacturing Practices (GMP)
Live Training Webinar - Date: Monday April 15, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Regulatory Aspects of Microbiology in a Non-Sterile Environment; A Review of the FDA Expectations & USP Non-Sterile Chapters
Live Training Webinar - Date: Monday April 29, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


The USP <1113> Microbial Characterization, Identification, and Strain Typing. What it Means to cGMP; Exploring Various Available Methodologies to Characterize and Identify Microorganisms
Live Training Webinar - Date: Tuesday April 30, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Bioburden Control Program; A Comprehensive Course on the Key Elements of a Bioburden Control Program, Monitoring of Bioburden and Inherent Methods in Sterile and Non-Sterile Products
Live Training Webinar - Date: Wednesday May 1, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


USP <1072> Disinfectants and Antiseptics - Use and Application of Sanitizers, Disinfectants and Sterilants
Live Training Webinar - Date: Thursday May 2, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Validation of Microbial Recovery; A Comprehensive Review of Microbial Recovery Methods & USP Microbial Methods Relationship to Method Suitability
Live Training Webinar - Date: Thursday May 2, 2019 - Time: 1:30 PM - 3:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Microbiological Issues In Non-Sterile Manufacturing & FDA Regulatory Expectations
Live Training Webinar - Date: Tuesday May 14, 2019 - Time: 1:30 PM - 3:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


New Proposed General Chapter USP <60> Microbiological Examination of Nonsterile Products - Tests for Burkholderia cepacia Complex
Live Training Webinar - Date: Thursday May 16, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments and Its Comparison & Contrast to FDA’s Guidance; Aseptic Processing (2004) and Annex 1 (2009)
Live Training Webinar - Date: Tuesday May 28, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


USP <71> Sterility Tests; Method, Limitations, Sampling Quantities and Volumes to Conform with United States
Live Training Webinar - Date: Thusday May 30, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


2019 Annual cGMP Training Program for Pharmaceutical Microbiologists - Latest FDA, USP, ISO, Canadian and EU Guidances and Regulatory Requirements

3-Part Live Training Program - Instructor: Barry A. Friedman Ph.D.

Part 1: The Laboratory Environment
Live Training Webinar - Date: Thursday June 6, 2019

Part 2: The Manufacturing Environment
Live Training Webinar - Date: Thursday June 27, 2019

Part 3 : The Non-Sterile and Aseptic Fill ‘n Finish Environment
Live Training Webinar - Date: Thursday July 11, 2019

Detailed 3-Part Live Training Program Agenda>>>


Microbiological cGMP Requirements for the Manufacturing Environment; From In-Coming Through to Final Release
Live Training Webinar - Date: Thursday June 27, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Microbiological cGMP Requirements for the Non-Sterile and Aseptic Fill ‘n Finish Environment
Live Training Webinar - Date: Thursday July 11, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Investigating FDA Data Integrity Regulatory Issues in a Manufacturing/Laboratory Environment, How cGMP Regulations Impact Data Integrity Issues and Key Elements in the Development & Implementation of a Data Integrity Program
Live Training Webinar - Date: Tuesday July 23, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Risk Management of Raw Materials in a GMP Environment – Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment
Live Training Webinar - Date: Tuesday August 6, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production– FDA & ICH Expectations and Guidance
Live Training Webinar - Date: Wednesday August 7, 2019 - Time: 1:30 - 3:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Microbial Data Deviation Investigations, The Role of Deviations, Out of Specifications, CAPAs and Risk Management within Microbial Data Deviations and How the FDA and ICH Regulations and Guidances Impact Them
Live Training Webinar - Date: Thursday August 8, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam
Live Training Webinar - Date: Thursday October 17, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>