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

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: Tuesday December 11, 2018 - Time: 9:30 - 11:30 AM 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: Tuesday December 18, 2018 - 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: Wednesday January 23, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Use and Application of Sanitizers, Disinfectants and Sterilants in a GMP Controlled and Classified Environment, Key Elements of a Robust Cleaning and Disinfection Program & Latest USP and FDA Requirements
2-Part Live Training Program - Instructor: Barry A. Friedman Ph.D.

Part 1: Use and Application of Sanitizers, Disinfectants and Sterilants in a GMP Controlled and Classified Environment – Latest Regulatory Requirements & Guidance
Live Training Webinar - Date: Thursday January 24, 2019

Part 2: Development and Implementation of a Robust Cleaning and Disinfection Program & The Use of USP<1072>, <1227> and <51> within the Development of Disinfectant Efficacy Programs
Live Training Webinar - Date: Thursday January 31, 2019

2-Part Live Training Program Time: 10:30 AM - 12:30 PM ET (New York Time)

Detailed 2-Part Live Training Program Agenda>>>


A Comprehensive Training on the Application of Steam in Place (SIP) Within a Manufacturing Facility & Methods to Destroy Microorganisms
Live Training Webinar - Date: Thursday January 31, 2019 - Time: 1:30 - 3:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Environmental Monitoring Fundamentals and 2019 FDA, EMA and Health Canada Key Regulatory Requirements of a Monitoring Program Within a cGMP Facility
Live Training Webinar - Date: Tuesday February 5, 2019 - Time: 10:30 AM - 12:30 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: Tuesday February 12, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Level Prescribed by GMPs
Live Training Webinar - Date: Tuesday February 12, 2019 - Time: 1:30 - 3:30 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 February 14, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


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

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

Part 1: USP <61>/<62> Microbiological Enumeration & Examination of Non-Sterile Products – Understanding the Current Standards for the New USP and Harmonized EP Microorganisms
Live Training Webinar - Date: Tuesday March 5, 2019

Part 2: USP <1111> Microbiological Examination of Non-Sterile Products; Controlling Microbial Contamination in Pharmaceutical/Biotech Non-Sterile & Sterile Manufacturing and the New Regulatory Attitude
Live Training Webinar - Date: Thursday March 7, 2019

Part 3 : 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 4: USP <51> Antimicrobial Effectiveness Testing – A New 2016 Revised Chapter
Live Training Webinar - Date: Thursday April 4, 2019

Part 5: 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 6: USP <1072> Disinfectants and Antiseptics - Use and Application of Sanitizers, Disinfectants and Sterilants
Live Training Webinar - Date: Thursday May 2, 2019

Part 7: - 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 8: - USP <71> Sterility Tests; Method, Limitations, Sampling Quantities and Volumes to Conform with United States
Live Training Webinar - Thursday May 30, 2019

Part 9: 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 9-Part Live Training Program Agenda>>>


USP <61>/<62> Microbiological Enumeration & Examination of Non-Sterile Products – Understanding the Current Standards for the New USP and Harmonized EP Microorganisms
Live Training Webinar - Date: Tuesday March 5, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Auditing to Meet FDA & USP Requirements and Guidances for Microbiological Aspects of Pharmaceutical Sterile & Non-Sterile Manufacturing
Live Training Webinar - Date: Tuesday March 5, 2019 - Time: 1:30 PM - 3:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


USP <1111> Microbiological Examination of Non-Sterile Products; Controlling Microbial Contamination in Pharmaceutical/Biotech Non-Sterile & Sterile Manufacturing and the New Regulatory Attitude
Live Training Webinar - Date: Thursday March 7, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Quality Agreements (Final Guidance, Nov. 2016): Purpose, Scope, Organization, Common Issues & A Comprehensive Review of the 2019 FDA Regulatory Requirements
Live Training Webinar - Date: Tuesday March 19, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Sterilization Procedures, Methods and the Use of Parametric Methods as a Method for Rapid Release of Sterilized Products
Live Training Webinar - Date: Tuesday March 19, 2019 - Time: 1:30 - 3:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


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>>>


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>>>


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>>>


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>>>