Upcoming Interactive Live Webinar Training Programs:

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Additional live webinars are continuously added to this list for 2019. Please continue to check this list for frequent updates.

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: Wednesday October 24, 2018 - Time: 9:30 - 11:30 AM 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: Thursday October 25, 2018 - Time: 09:30 AM - 11:30 AM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Fundamental Principles of Method Transfer, A Comprehensive Review of USP <1224> and Key Factors that Influence the Transfer of Analytical Methods
Live Training Webinar - Date: Tuesday October 30, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations, Key Components, Avoiding Deficiencies and Ensuring Continuous Improvement through a Complete Investigation Process

3-Part Live Training Program - Instructor: Kim Huynh-Ba

Part 1: Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar - Date: Wednesday October 31, 2018

Part 2: Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar - Date: Wednesday November 28, 2018

Part 3: Laboratory Deficiencies and How to Minimize OOS/OOT
Live Training Webinar - Wednesday December 5, 2018

Detailed 3-Part Live Training Program Agenda>>>


Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar - Date: Wednesday October 31, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Laboratory Quality Practices for Global Regulatory CMC Analytical Studies for Biotechnology/Biosimilar Products: R&D to GMP
Live Training Webinar - Date: Thursday November 1, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Nadine M. Ritter Ph.D.
Detailed Information>>>


Cleaning Validation; Understanding Variations on Expression of Limits and Special Cases in Setting Residue Limits & Regulatory Concerns
Live Training Webinar - Date: Tuesday November 6, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Cold Chain Management - The Latest Regulatory Requirements for Product Distribution in the USA, Canada, and the EU; Detailed Analysis of the EU GDP Guidance
Live Training Webinar - Date: Wednesday November 7, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Cleaning Validation; Design of Automated and Manual Cleaning Processes & Latest Regulatory Requirements
Live Training Webinar - Date: Thursday November 8, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Lot Disposition; A Thorough Review and Comparison of the Latest Regulatory Expectations Governing and Controlling Lot Disposition in US, Canada and the EU
Live Training Webinar - Date: Tuesday November 13, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Human Errors in GMP Manufacturing and Laboratory Processes; Identification, Correction and Prevention, Latest FDA Regulatory Requirements & Most Common GMP Issues Caused by Human Error
Live Training Webinar - Date: Wednesday November 14, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Batch Record Review Process; 2018 FDA, EU and Canada Regulatory Requirements, Key Elements of the Review Process & Emerging Technologies
Live Training Webinar - Date: Thursday November 15, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Analytical Method Modification and Change Control Process; Documentation System, cGMP Requirements and a Review of Q2 A & B for Method Validation Activities
Live Training Webinar - Date: Tuesday November 27, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar - Date: Wednesday November 28, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Meeting the Latest Regulatory GMP Requirements During Clinical Manufacturing, Understanding Key Differences in Implementing GMPs in Clinical vs. Commercial Manufacturing
Live Training Webinar - Date: Thursday November 29, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Cleaning Validation: Issues in the Validation of Manual and Automated Cleaning Processes & Latest Regulatory References
Live Training Webinar - Date: Tuesday December 4, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Laboratory Deficiencies and How to Minimize OOS/OOT
Live Training Webinar - Date: Wednesday December 5, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Cleaning Validation: Dealing with Dedicated Equipment and with Campaigns
Live Training Webinar - Date: Thursday December 6, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Destin LeBlanc
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: Tuesday December 11, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements and the Impact of the New FDA Quality Metrics Guidance on Annual Product Reviews
Live Training Webinar - Date: Wednesday December 12, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Jerry Lanese Ph.D.
Detailed Information>>>


GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry Including a Review of the New 2018 MHRA Data Integrity Definitions & Guidances and the FDA’s Most Recent Draft Guidance
Live Training Webinar - Date: Thursday December 13, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Peter Calcott 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>>>


Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations
Live Training Webinar - Date: Wednesday December 19, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Jerry Lanese Ph.D.
Detailed Information>>>


Current FDA and Global cGMP Compliance Requirements and Guidances for In-House and Contract Analytical QC Laboratories; Understanding the Unique Elements of cGMP Applicable to QC Analytical Testing Laboratories
Live Training Webinar - Date: Thursday January 17, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Nadine M. Ritter 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>>>


2019 Annual Pharmaceutical Impurities Training Program

4-Part Live Training Program - Instructors: Kim Huynh-Ba and Anthony J. DeStefano Ph.D.

Part 1: FDA Guideline on Analytical Procedures and Method Validation with Application to Impurities
Live Training Webinar - Date: Wednesday January 30, 2019

Part 2: Understanding the Impact of FDA, ICH, USP and EMEA impurity guidelines, and data needed to establish acceptance criteria according to the FDA Manual of Policy and Procedure (MAPP)
Live Training Webinar - Date: Wednesday February 27, 2019

Part 3: Elemental Impurities Compliance for the Pharmaceutical Industry; Understanding and Implementing USP General Chapters <232> & <233> and A Review of ICH Q3D
Live Training Webinar - Date: Wednesday March 27, 2019

Part 4 : Monitoring Organic Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Wednesday April 24, 2019

Detailed 4-Part Live Training Program Agenda>>>


FDA New Guidance on Analytical Procedures and Method Validation for Drugs and Biologics Chapters <232> & <233> and A Review of ICH Q3D
Live Training Webinar - Date: Wednesday January 30, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Anthony J. DeStefano Ph.D.
Detailed Information>>>


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>>>


Process Validation General Principles & Practices – Integrating the FDA and EU Guidance; ICH Q8, ICH Q9, ICH Q10 and Quality Metrics
Live Training Webinar - Date: Wednesday February 13, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Jerry Lanese Ph.D.
Detailed Information>>>


Pharmaceutical Cleaning Validation Training Program; From Key Fundamentals Through to the Most Advanced Cleaning Validation Processes, Methods and Topics Including Comprehensive Examination of the Latest FDA, EU, EMA, Health Canada and Other Regulatory Requirements & Guidelines Related to Cleaning Validation
19-Part Live Training Program - Instructor: Destin LeBlanc

Part 1: Cleaning Validation Fundamentals - Robust Strategies for Designing and Improving Cleaning Validation Programs
Live Training Webinar - Date: Tuesday February 26, 2019

Part 2: Designing and Implementing a Lifecycle Approach for Cleaning Validation
Live Training Webinar - Date: Thursday February 28, 2019

Part 3: Basic Limit Setting for Cleaning Validation Protocols and the Latest Regulatory Expectations
Live Training Webinar - Date: Tuesday March 26, 2019

Part 4: Cleaning Validation - Chemical Analytical Methods, Analytical Method Validation & Latest Regulatory Expectations
Live Training Webinar - Date: Thursday March 28, 2019

Part 5: Sampling Methods and Sampling Recoveries for Cleaning Validation & 2019 Regulatory Expectations
Live Training Webinar - Date: Tuesday April 23, 2019

Part 6: Microbiological Issues in Cleaning Validation and How to Control Bioburden
Live Training Webinar - Date: Thursday April 25, 2019

Part 7: Grouping Strategies for Cleaning Validation - Using Science and Data-Driven Grouping Approaches to Effectively Accomplish Cleaning Validation & Regulatory Recommendations
Live Training Webinar - Date: Tuesday May 21, 2019

Part 8: Cleaning Validation - Maintaining Cleaning Processes in a “State of Control” & Understanding Vital Validation Maintenance Procedures
Live Training Webinar - Date: Thursday May 23, 2019

Part 9: Examining Regulatory Requirements for: Cleaning Validation Overview, Life Cycle Approach for Cleaning Validation, Design and Development of Cleaning Processes and Cleaning Validation Protocols and Reports
Live Training Webinar - Date: Tuesday June 18, 2019

Part 10: Examining Regulatory Requirements for: Setting Limits and Analytical Methods and Method Validation
Live Training Webinar - Date: Tuesday July 16, 2019

Part 11: Examining Regulatory Requirements for: Sampling and Sampling Recovery, Dirty Hold Time, Clean Hold Time, Microbiological Issues and Validation Maintenance
Live Training Webinar - Date: Tuesday August 13, 2019

Part 12: Cleaning Validation; Utilizing “Health-Based” Limits, Toxicological Evaluation VS. Dose-Base Criterion, Examination of ISPE Approach and EMA’s New Dedication Guidance
Live Training Webinar - Date Tuesday September 24, 2019

Part 13: Utilizing “Health-Based” Limits for Cleaning Validation; Practical Considerations in Implementing “Health-Based” Limits into Protocols
Live Training Webinar - Date: Thursday September 26, 2019

Part 14: Cleaning Validation; Dealing with “Indirect Product Contact Surfaces” and “Non-Product Contact Surfaces” & Regulatory Recommendations
Live Training Webinar - Date: Tuesday October 22, 2019

Part 15: Cleaning Validation; Issues in the Use of Total Organic Carbon (TOC) as an Analytical Technique
Live Training Webinar - Date: Thursday October 24, 2019

Part 16: Cleaning Validation; Understanding Variations on Expression of Limits and Special Cases in Setting Residue Limits & Regulatory Concerns
Live Training Webinar - Date: Tuesday November 19, 2019

Part 17: Cleaning Validation; Design of Automated and Manual Cleaning Processes & Latest Regulatory Requirements
Live Training Webinar - Date: Thursday November 21, 2019

Part 18: Cleaning Validation: Issues in the Validation of Manual and Automated Cleaning Processes & Latest Regulatory References
Live Training Webinar - Date: Tuesday December 10, 2019

Part 19: Cleaning Validation: Dealing with Dedicated Equipment and with Campaigns
Live Training Webinar - Date: Thursday December 12, 2019

Detailed 19-Part Live Training Program Agenda>>>


2019 Annual Pharmaceutical Cleaning Validation Training Program
8-Part Live Training Program - Instructor: Destin LeBlanc

Part 1: Cleaning Validation Fundamentals - Robust Strategies for Designing and Improving Cleaning Validation Programs
Live Training Webinar - Date: Tuesday February 26, 2019

Part 2: Designing and Implementing a Lifecycle Approach for Cleaning Validation
Live Training Webinar - Date: Thursday February 28, 2019

Part 3: Basic Limit Setting for Cleaning Validation Protocols and the Latest Regulatory Expectations
Live Training Webinar - Date: Tuesday March 26, 2019

Part 4: Cleaning Validation - Chemical Analytical Methods, Analytical Method Validation & Latest Regulatory Expectations
Live Training Webinar - Date: Thursday March 28, 2019

Part 5: Sampling Methods and Sampling Recoveries for Cleaning Validation & 2019 Regulatory Expectations
Live Training Webinar - Date: Tuesday April 23, 2019

Part 6: Microbiological Issues in Cleaning Validation and How to Control Bioburden
Live Training Webinar - Date: Thursday April 25, 2019

Part 7: Grouping Strategies for Cleaning Validation - Using Science and Data-Driven Grouping Approaches to Effectively Accomplish Cleaning Validation & Regulatory Recommendations
Live Training Webinar - Date: Tuesday May 21, 2019

Part 8: Cleaning Validation - Maintaining Cleaning Processes in a “State of Control” & Understanding Vital Validation Maintenance Procedures
Live Training Webinar - Date: Thursday May 23, 2019

Detailed 8-Part Live Training Program Agenda>>>


Cleaning Validation Fundamentals - Robust Strategies for Designing and Improving Cleaning Validation Programs
Live Training Webinar - Date: Tuesday February 26, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Understanding the Impact of FDA, ICH, USP and EMEA Impurity Guidelines, and the Data Needed to Establish Acceptance Criteria According to the FDA Manual of Policy and Procedure (MAPP)
Live Training Webinar - Date: Wednesday February 27, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Designing and Implementing a Lifecycle Approach for Cleaning Validation
Live Training Webinar - Date: Thursday February 28, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
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 - 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>>>


2019 Annual Pharmaceutical GMP Training Program; Comprehensive Training on the Most Up to Date FDA & Global GMP Requirements and Best Practices

8-Part Live Training Program - Instructors: Peter Calcott Ph.D. & Kim Huynh-Ba

Part 1: Quality Management System (QMS) – The New FDA, EU and Global Regulatory Requirements, Maintaining the Validated State and Driving for Consistency
Live Training Webinar - Tuesday March 12, 2019

Part 2: Quality Management System (QMS) – Handling Deviations and Out-of-Spec (OOS) Investigations Based on the Latest FDA, EMA and Global Regulatory Requirements
Live Training Webinar – Date: Thursday March 14, 2019

Part 3 : Quality Management System (QMS) – The New QMS Paradigm Explained
Live Training Webinar - Date: Tuesday April 9, 2019

Part 4 : Facilities and Equipment – Linking the Latest FDA , EMA and Other Regulatory Bodies' Regulatory Expectations With Respect to Design, Construction, Start Up and Commissioning of Facilities and Utilities to Best Practices
Live Training Webinar - Date: Thursday April 11, 2019

Part 5: Latest FDA EMA & Other Regulatory Requirements of Pharmaceutical Manufacturing; from Manufacturing of Bulk Drugs to Finished Product Including Packaging and Labeling Activities
Live Training Webinar - Date: Tuesday May 7, 2019

Part 6: Key GMP Requirements of Pharmaceutical Laboratories – Understanding the Latest FDA & Global Regulatory Requirements
Live Training Webinar - Date: Thursday May 9, 2019

Part 7: Raw Materials and Components Management – Latest Regulatory Requirements including a Review of the EMA Falsified Medicines Directive, Food and Drug Administration Safety and Integrity Act (FDAsia), Drug Supply Chain Security Act (DSCSA), & Secure Supply Chain Pilot Program (SSCPP)
Live Training Webinar - Date: Tuesday June 11, 2019

Part 8: GMP Requirements for Records and Reports – Documenting Your GMP Activities; Understanding the Vital GMP Requirements of a Documentation System
Live Training Webinar - Date: Thursday June 13, 2019

Detailed 8-Part Live Training Program Agenda>>>


Quality Management System (QMS) – The New FDA, EU and Global Regulatory Requirements, Maintaining the Validated State and Driving for Consistency
Live Training Webinar - Date: Tuesday March 12, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


2019 Annual Pharmaceutical Stability Training Program

6-Part Live Training Program - Instructor: Kim Huynh-Ba

Part 1: Understanding FDA & International Stability Requirements in the Drug Development Process including WHO, ASEAN and ICH Q1AR2
Live Training Webinar - Date: Wednesday March 13, 2019

Part 2: Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar – Date: Wednesday April 10, 2019

Part 3 : Change Control for the Stability Program: GMP Requirements & Potential Risks Involved
Live Training Webinar - Date: Wednesday May 8, 2019

Part 4 : A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar - Date: Wednesday June 12, 2019

Part 5: Developing and Validating Stability Indicating Methods to support Stability Program using Forced Degradation Studies
Live Training Webinar - Date: Wednesday July 10, 2019

Part 6: Monitoring Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Date: Wednesday August 14, 2019

Detailed 6-Part Live Training Program Agenda>>>


FDA & International Stability Requirements in the Drug Development Process including WHO, ASEAN and ICH Q1AR2
Live Training Webinar - Date: Wednesday March 13, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Quality Management System (QMS) – Handling Deviations and Out-of-Spec (OOS) Investigations Based on the Latest FDA, EMA and Global Regulatory Requirements
Live Training Webinar - Date: Thursday March 14, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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>>>


2019 Annual Product Quality Reviews Training Program
Annual Product Quality Reviews Preparation & Reports - FDA, EU, Canada, Japan, China, WHO, and PIC/S Regulatory Requirements

Annual 4-Part Live Training Program - Instructor: Jerry Lanese Ph.D.

Part 1 The Requirements
Live Training Webinar - Date: Wednesday March 20, 2019

Part 2: The Evolution
Live Training Webinar - Date: Wednesday April 17, 2019

Part 3: The Content
Live Training Webinar - Date: Wednesday May 15, 2019

Part 4: The Expanding Role, Responsibilities and Integration
Live Training Webinar - Wednesday June 19, 2019

Detailed 4-Part Live Training Program Agenda>>>


Basic Limit Setting for Cleaning Validation Protocols and the Latest Regulatory Expectations
Live Training Webinar - Date: Tuesday March 26, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Elemental Impurities Compliance for the Pharmaceutical Industry; Understanding and Implementing USP General Chapters <232> & <233> and A Review of ICH Q3D
Live Training Webinar - Date: Wednesday March 27, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Anthony J. DeStefano Ph.D.
Detailed Information>>>


Cleaning Validation - Chemical Analytical Methods, Analytical Method Validation & Latest Regulatory Expectations
Live Training Webinar - Date: Thursday March 28, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
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>>>


Quality Management System (QMS) – The New QMS Paradigm Explained - Comparing Commonalities Between FDA, EMA and Other International Regulatory Requirements
Live Training Webinar - Date: Tuesday April 9, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Facilities and Equipment – Linking the Latest FDA , EMA and Other Regulatory Bodies' Regulatory Expectations With Respect to Design, Construction, Start Up and Commissioning of Facilities and Utilities to Best Practices
Live Training Webinar - Date: Thursday April 11, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott 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: 9:30 - 11:30 AM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Sampling Methods and Sampling Recoveries for Cleaning Validation & 2019 Regulatory Expectations
Live Training Webinar - Date: Tuesday April 23, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Monitoring Organic Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Date: Wednesday April 24, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Microbiological Issues in Cleaning Validation and How to Control Bioburden
Live Training Webinar - Date: Thursday April 25, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
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>>>


Latest FDA EMA & Other Regulatory Requirements of Pharmaceutical Manufacturing; from Manufacturing of Bulk Drugs to Finished Product Including Packaging and Labeling Activities
Live Training Webinar - Date: Tuesday May 7, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Key GMP Requirements of Pharmaceutical Laboratories – Understanding the Latest FDA & Global Regulatory Requirements
Live Training Webinar - Date: Thursday May 9, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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>>>


Supply Chain Security – An Inclusive Examination of the Latest Challenges in Technical and Cold Chain Areas from Procurement of Raw Materials to Distribution of Drug Products & Latest FDA, Canada & EU Regulatory Requirements
2-Part Live Training Program - Instructor: Peter Calcott Ph.D.

Part 1: Part 1 - Supply Chain Security – Understanding the Latest FDA, Canada and EU Regulatory Requirements
Live Training Webinar - Date: Wednesday May 29, 2019

Part 2: Supply Chain Security – How the EU, Canada and USA Approach the Requirements to Protect Our Products and the Direction it is Heading
Live Training Webinar - Date: Wednesday June 5 2019

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

Detailed 2-Part Live Training Program Agenda>>>


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>>>


Raw Materials and Components Management – Latest Regulatory Requirements including a Review of the EMA Falsified Medicines Directive, Food and Drug Administration Safety and Integrity Act (FDAsia), Drug Supply Chain Security Act (DSCSA), & Secure Supply Chain Pilot Program (SSCPP)
Live Training Webinar - Date: Tuesday June 11, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


GMP Requirements for Records and Reports – Documenting Your GMP Activities; Understanding the Vital GMP Requirements of a Documentation System
Live Training Webinar - Date: Thursday June 13, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


2019 Pharmaceutical Cleaning Validation Regulatory Compliance Training Program
A Comprehensive Review of the Latest FDA, EU, EMA, Health Canada Regulatory Documents and Guidelines

3-Part Live Training Program - Instructor: Destin LeBlanc

Part 1: Examining regulatory requirements for:
• Cleaning Validation Overview
• Life Cycle Approach for Cleaning Validation
• Design and Development of Cleaning Processes
• Cleaning Validation Protocols and Reports
Live Training Webinar - Date: Tuesday June 18, 2019

Part 2: Examining regulatory requirements for:
• Setting Limits
• Analytical Methods and Method Validation
Live Training Webinar - Date: Tuesday July 16, 2019

Part 3: Examining regulatory requirements for:
• Sampling and Sampling Recovery
• Dirty Hold Time
• Clean Hold Time
• Microbiological Issues
• Validation Maintenance
Live Training Webinar - Date: Tuesday August 13, 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>>>


2019 Annual Method Validation Training Program; Latest Regulatory Expectations and Guidance from FDA, ICH, USP & Best Practices for GMP Pharmaceutical Laboratories

4-Part Live Training Program - Instructor: Kim Huynh-Ba

Part 1: Validation Life-Cycle Management (LCM) of Analytical Procedures According to FDA, ICH and USP Requirements
Live Training Webinar - Date: Tuesday September 10, 2019

Part 2: Developing an Effective Method Validation Protocol
Live Training Webinar - Date: Tuesday October 1, 2019

Part 3: Method Transfer: A Systematic Way to Quality New Lab to Perform Analytical Testing
Live Training Webinar - Date: Tuesday October 29, 2019

Part 4: Analytical Method Modification and Change Control Process
Live Training Webinar - Date: Tuesday November 12, 2019

Detailed 4-Part Live Training Program Agenda>>>


Developing an Effective Method Validation Protocol
Live Training Webinar - Date: Tuesday October 1, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


2019 Annual Advanced Cleaning Validation Training Program
8-Part Live Training Program - Instructor: Destin LeBlanc

Part 1: Cleaning Validation; Utilizing “Health-Based” Limits, Toxicological Evaluation VS. Dose-Base Criterion, Examination of ISPE Approach and EMA’s New Dedication Guidance
Live Training Webinar - Date: Tuesday September 24, 2019

Part 2: Utilizing “Health-Based” Limits for Cleaning Validation; Practical Considerations in Implementing “Health-Based” Limits into Protocols
Live Training Webinar - Date: Thursday September 26, 2019

Part 3: Cleaning Validation; Dealing with “Indirect Product Contact Surfaces” and “Non-Product Contact Surfaces” & Regulatory Recommendations
Live Training Webinar - Date: Tuesday October 22, 2019

Part 4: Cleaning Validation; Issues in the Use of Total Organic Carbon (TOC) as an Analytical Technique
Live Training Webinar - Date: Thursday October 24, 2019

Part 5: Cleaning Validation; Understanding Variations on Expression of Limits and Special Cases in Setting Residue Limits & Regulatory Concerns
Live Training Webinar - Date: Tuesday November 19, 2019

Part 6: Cleaning Validation; Design of Automated and Manual Cleaning Processes & Latest Regulatory Requirements
Live Training Webinar - Date: Thursday November 21, 2019

Part 7: Cleaning Validation: Issues in the Validation of Manual and Automated Cleaning Processes & Latest Regulatory References
Live Training Webinar - Date: Tuesday December 10, 2019

Part 8: Cleaning Validation: Dealing with Dedicated Equipment and with Campaigns
Live Training Webinar - Date: Thursday December 12, 2019

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

Detailed 8-Part Live Training Program Agenda>>>


Cleaning Validation; Utilizing “Health-Based” Limits, Toxicological Evaluation VS. Dose-Base Criterion, Examination of ISPE Approach and EMA’s New Dedication Guidance
Live Training Webinar - Date: Tuesday September 24, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Utilizing “Health-Based” Limits for Cleaning Validation; Practical Considerations in Implementing “Health-Based” Limits into Protocols
Live Training Webinar - Date: Thursday September 26, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Cleaning Validation; Dealing with “Indirect Product Contact Surfaces” and “Non-Product Contact Surfaces” & Regulatory Recommendations
Live Training Webinar - Date: Tuesday October 22, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Cleaning Validation; Issues in the Use of Total Organic Carbon (TOC) as an Analytical Technique
Live Training Webinar - Date: Thursday October 24, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Additional live webinars are continuously added to this list for 2019. Please continue to check this list frequently for new updates.
 
Professional development and technical training through exclusively interactive, instructor-led, real time online training programs which highlight the most recent regulatory expectations and operational trends in the Pharmaceutical industry.

Clients:

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Testimonials:

 "The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

  "We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

  "Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

  "This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

  "We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

  "Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

  "Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

  "Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

  "Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

  "Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

  "We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland

 
Additional Live Webinars are continuously added to this list. Please continue to check this list for updates.