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.

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
17-Part Live Training Program - Instructor: Destin LeBlanc

Part 1: Basic Limit Setting for Cleaning Validation Protocols and the Latest Regulatory Expectations
Live Training Webinar - Date: Tuesday March 26, 2019 (Completed)

Part 2: Cleaning Validation - Chemical Analytical Methods, Analytical Method Validation & Latest Regulatory Expectations
Live Training Webinar - Date: Thursday March 28, 2019

Part 3: Sampling Methods and Sampling Recoveries for Cleaning Validation & 2019 Regulatory Expectations
Live Training Webinar - Date: Tuesday April 23, 2019

Part 4: Microbiological Issues in Cleaning Validation and How to Control Bioburden
Live Training Webinar - Date: Thursday April 25, 2019

Part 5: 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 6: Cleaning Validation - Maintaining Cleaning Processes in a “State of Control” & Understanding Vital Validation Maintenance Procedures
Live Training Webinar - Date: Thursday May 23, 2019

Part 7: 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 8: Examining Regulatory Requirements for: Setting Limits and Analytical Methods and Method Validation
Live Training Webinar - Date: Tuesday July 16, 2019

Part 9: 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 10: 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 11: 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 12: Cleaning Validation; Dealing with “Indirect Product Contact Surfaces” and “Non-Product Contact Surfaces” & Regulatory Recommendations
Live Training Webinar - Date: Tuesday October 22, 2019

Part 13: Cleaning Validation; Issues in the Use of Total Organic Carbon (TOC) as an Analytical Technique
Live Training Webinar - Date: Thursday October 24, 2019

Part 14: 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 15: Cleaning Validation; Design of Automated and Manual Cleaning Processes & Latest Regulatory Requirements
Live Training Webinar - Date: Thursday November 21, 2019

Part 16: Cleaning Validation: Issues in the Validation of Manual and Automated Cleaning Processes & Latest Regulatory References
Live Training Webinar - Date: Tuesday December 10, 2019

Part 17: Cleaning Validation: Dealing with Dedicated Equipment and with Campaigns
Live Training Webinar - Date: Thursday December 12, 2019

Detailed 17-Part Live Training Program Agenda>>>


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>>>


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>>>


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>>>


2019 Annual Pharmaceutical Stability Training Program

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

Part 1: 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 2: Change Control for the Stability Program: GMP Requirements & Potential Risks Involved
Live Training Webinar - Date: Wednesday May 8, 2019

Part 3: 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 4: Developing and Validating Stability Indicating Methods to support Stability Program using Forced Degradation Studies
Live Training Webinar - Date: Wednesday July 10, 2019

Part 5: Monitoring Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Date: Wednesday August 14, 2019

Detailed 5-Part Live Training Program Agenda>>>


Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar - Date: Wednesday April 10, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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>>>


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 (Completed)

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>>>


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>>>


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>>>


Change Control for the Stability Program, GMP Requirements & A Review of the Potential Risks Involved
Live Training Webinar - Date: Wednesday May 8, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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>>>


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>>>


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: Wednesday May 22, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott 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>>>


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 June 4, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott 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>>>


A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar - Date: Wednesday June 12, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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>>>


Laboratory Quality Practices for Global Regulatory CMC Analytical Studies for Biotechnology/Biosimilar Products: R&D to GMP
Live Training Webinar - Date: Monday June 17, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Nadine M. Ritter Ph.D.
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>>>


Developing and Validating Stability Indicating Methods to Support Stability Program Using Forced Degradation Studies
Live Training Webinar - Date: Wednesday July 10, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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 Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations
Live Training Webinar - Date: Wednesday July 17, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Jerry Lanese Ph.D.
Detailed Information>>>


Batch Record Review Process; 2019 FDA, EU and Canada Regulatory Requirements, Key Elements of the Review Process & Emerging Technologies
Live Training Webinar - Date: Thursday July 18, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott 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>>>


Monitoring Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Date: Wednesday August 14, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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 August 20, 2019 - Time: 10:30 AM - 12:30 PM ET(New York Time)
Instructor: Peter Calcott 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 August 21, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Jerry Lanese Ph.D.
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: Thursday August 22, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott 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: Monday August 26, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Nadine M. Ritter Ph.D.
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 August 29, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Supply Chain Security – A Comprehensive Examination of the Latest Technical Challenges from Procurement of Raw Materials to Distribution of Drug Products & Latest FDA, Canada & EU Regulatory Requirements
Live Training Webinar - Date: Wednesday September 4, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Peter Calcott 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: 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 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>>>


Validation Life-Cycle Management (LCM) of Analytical Procedures According to FDA, ICH and USP Requirements
Live Training Webinar - Date: Tuesday September 10, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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: Tuesday September 17, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
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>>>


FDA Guidance on Analytical Procedures and Method Validation and its Relationship to Upcoming ICH Q2 and USP <1220> Initiatives
Live Training Webinar - Date: Wednesday September 25, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Anthony J. DeStefano Ph.D.
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>>>


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>>>


Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Best Practices, Key Components and a Comprehensive Review of the FDA Requirements - Avoiding Deficiencies and Ensuring Continuous Improvement through a Complete Investigation Process

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

Part 1: Identification of Out-of-Specification (OOS) and the Investigation Process - A Comprehensive Review of the FDA Guidance and Requirements
Live Training Webinar - Date: Wednesday October 2, 2019

Part 2: Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar - Date: Wednesday October 30, 2019

Part 3: Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar - Date: Wednesday November 13, 2019

Part 4 : Laboratory Deficiencies and How to Minimize OOS/OOT
Live Training Webinar - Wednesday December 4, 2019

Detailed 4-Part Live Training Program Agenda>>>


Identification of Out-of-Specification (OOS) and the Investigation Process - A Comprehensive Review of the FDA Guidance and Requirements
Live Training Webinar - Date: Wednesday October 2, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


FDA & International Stability Requirements in the Drug Development Process including WHO, ASEAN and ICH Q1AR2
Live Training Webinar - Date: Thursday October 3, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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>>>


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>>>


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 29, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar - Date: Wednesday October 30, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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 12, 2019 - Time: 10:30 AM - 12:30 PM 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 13, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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 19, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


Cleaning Validation; Design of Automated and Manual Cleaning Processes & Latest Regulatory Requirements
Live Training Webinar - Date: Thursday November 21, 2019 - Time: 10:30 AM - 12:30 PM 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 4, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Cleaning Validation: Issues in the Validation of Manual and Automated Cleaning Processes & Latest Regulatory References
Live Training Webinar - Date: Tuesday December 10, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
Detailed Information>>>


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