Upcoming Live Training Programs:
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: Thursday July 20, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Anthony J. DeStefano Ph.D.
EU GMP Annex 1: Manufacture of Sterile Medicinal Products - An overview of what it contains, what it means and how it affects your operations worldwide
Live Training Webinar
Date: Thursday July 27, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
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: Thursday July 27, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
FDA's Endotoxins/Pyrogens 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 August 1, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
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: Thursday August 10, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
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: Tuesday August 15, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Jerry Lanese Ph.D.
FDA Guidance on Analytical Procedures and Method Validation and its Relationship to ICH Q2 and USP <1220> Initiatives
Live Training Webinar
Date: Wednesday August 16, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Anthony J. DeStefano Ph.D.
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: Tuesday August 22, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Routine Monitoring and Visual Residue Limits - Understanding the Differences Between the Objectives of a Cleaning Validation Protocol and Routine Monitoring
Live Training Webinar
Date: Wednesday August 23, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
2023 Annual cGMP Training Program for Pharmaceutical Microbiologists
Latest FDA, USP, ISO, Canadian and EU Guidances and Regulatory Requirements
3-Part Live Interactive Training Webinar Series
Part 1: The Laboratory Environment
Live Training Webinar - Date: Thursday August 24, 2023
Part 2: The Manufacturing Environment
Live Training Webinar - Date: Thursday September 7, 2023
Part 3: The Non-Sterile and Aseptic Fill ‘n Finish Environment
Live Training Webinar - Date: Thursday September 21, 2023
Instructor: Barry Friedman Ph.D.
Stability Testing in Pharmaceutical Development Certification Program.
Understanding critical attributes to develop the stability program to support pharmaceutical products and best practices to get the most out of your stability data, maintain compliance with GMP, FDA, ICH, and USP expectations throughout the product lifecycle
12-Part Live Training Program - Instructor: Kim Huynh-Ba
Part 1: Examining the FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories
Live Training Webinar - Date: Tuesday August 29, 2023
Part 2: Establishing a Reference Standard Program According to GMP Requirements and Understanding United States Pharmacopeia (USP) Compendial Monographs
Live Training Webinar – Date: Tuesday September 12, 2023
Part 3: Developing an Effective Method Validation Protocol
Live Training Webinar - Date: Tuesday October 10, 2023
Part 4: Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar – Date: Wednesday October 11, 2023
Part 5: Fundamental Principles of Method Transfer: A Systematic Way to Qualify a New Lab to Perform Analytical Testing & A Review of USP <1224>
Live Training Webinar – Date: Tuesday October 17, 2023
Part 6: 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 October 31, 2023
Part 7: Understanding FDA & International Stability Requirements in the Drug Development Process including WHO, ASEAN and ICH Q1AR2
Live Training Webinar - Date: Wednesday November 1, 2023
Part 8: Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar – Date: Wednesday November 8, 2023
Part 9: Change Control for the Stability Program: GMP Requirements & Potential Risks Involved
Live Training Webinar - Date: Wednesday November 15, 2023
Part 10: A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar – Date: Wednesday November 29, 2023
Part 11: Developing and Validating Stability Indicating Methods to support Stability Program using Forced Degradation Studies
Live Training Webinar - Date: Wednesday December 6, 2023
Part 12: Design and Implement an Effective Stability Program to Support Marketed Products and Maintain Compliance to the Latest FDA, ICH and WHO Regulatory Requirements
Live Training Webinar – Date: Wednesday December 13, 2023
Examining the FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories. Key Requirements to Ensure Compliance, How to Defend Your Position During a Regulatory Audit and Understanding Key Inspection Differences in Quality Assurance vs. Quality Control
Live Training Webinar
Date: Tuesday August 29, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Examining and Applying the Use of Statistics in Pharmaceutical Cleaning Validation - An In-Depth Review of Statistical Principles and Practices, Including Process Capability Indexes
Live Training Webinar
Date: Wednesday August 30, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc
Batch Record Review Process; 2023 FDA, EU and Canada Regulatory Requirements, Key Elements of the Review Process & Emerging Technologies
Live Training Webinar
Date: Thursday August 31, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry - A Comprehensive Review of the Latest MHRA Data Integrity Definitions and Guidances Including the FDA’s Most Recent Guidance
Live Training Webinar
Date: Thursday September 7, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Establishing a Reference Standard Program According to GMP Requirements and Understanding United States Pharmacopeia (USP) Compendial Monographs
Live Training Webinar
Date: Tuesday September 12, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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 September 13, 2023
Part 2: Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar - Date: Wednesday September 27, 2023
Part 3: Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar - Date: Wednesday October 11, 2023
Part 4 : Laboratory Deficiencies and How to minimize OOS/OOT
Live Training Webinar – Date: Wednesday October 18, 2023
Identification of Out-of-Specification (OOS) and the Investigation Process - A Comprehensive Review of the FDA Guidance and Requirements
Live Training Webinar
Date: Wednesday September 13, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Meeting the Latest Regulatory GMP Requirements During Clinical Manufacturing, Understanding Key Differences in Implementing GMPs in Clinical vs. Commercial Manufacturing
Live Training Webinar
Date: Tuesday September 19, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
2023 Annual Advanced Pharmaceutical Cleaning Validation Training Program
8-Part Live Training Program - Instructor: Destin A. 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 26, 2023
Part 2: Utilizing “Health-Based” Limits for Cleaning Validation; Practical Considerations in Implementing “Health-Based” Limits into Protocols
Live Training Webinar – Date: Thursday September 28, 2023
Part 3: Cleaning Validation; Dealing with “Indirect Product Contact Surfaces” and “Non-Product Contact Surfaces” & Regulatory Recommendations
Live Training Webinar - Date: Tuesday October 24, 2023
Part 4: Cleaning Validation; Issues in the Use of Total Organic Carbon (TOC) as an Analytical Technique
Live Training Webinar – Date: Thursday October 26, 2023
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 28, 2023
Part 6: Cleaning Validation; Design in the Validation of Automated & Manual Cleaning Processes & Latest Regulatory Requirements
Live Training Webinar – Date: Thursday November 30, 2023
Part 7: Cleaning Validation: Visually Clean and Visual Residue Limits
Live Training Webinar - Date: Tuesday December 12, 2023
Part 8: Cleaning Validation: Dealing with Dedicated Equipment and with Campaigns
Live Training Webinar – Date: Thursday December 14, 2023
2023 Method Validation Training Program; Latest Regulatory Expectations and Guidance from FDA, ICH, USP & Best Practices for GMP Pharmaceutical Laboratories
Annual 4-Part Live Training Program - Instructor: Kim Huynh-Ba
Part 1: Life-Cycle Management (LCM) of Analytical Procedures and Key Validation Parameters - FDA, ICH and USP Requirements
Live Training Webinar - Date: Tuesday September 26, 2023
Part 2: Developing an Effective Method Validation Protocol; Systems for Protocol Amendment, Deviations & How to Handle Protocol Failures and Investigations
Live Training Webinar - Date: Tuesday October 10, 2023
Part 3: Fundamental Principles of Method Transfer: A Systematic Way to Qualify a New Lab to Perform Analytical Testing & A Review of USP
Live Training Webinar - Date: Tuesday October 17, 2023
Part 4 : Analytical Method Modification, Validation and Change Control Process; Documentation System, cGMP Requirements and a Review of Q2 A & B for Method Validation Activities
Live Training Webinar – Date: Tuesday October 31, 2023
Life-Cycle Management (LCM) of Analytical Procedures and Key Validation Parameters - FDA, ICH and USP Requirements
Live Training Webinar
Date: Tuesday September 26, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar
Date: Wednesday September 27, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Control of Nitrosamine Impurities in Human Drugs - Understanding FDA's Final Guidance for Industry, USP Chapter <1469> and an In-depth Discussion of Sample Preparation Issues, Methodology and Acceptance Criteria
Live Training Webinar
Date: Thursday October 5, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Anthony J. DeStefano Ph.D.
Developing an Effective Method Validation Protocol; Systems for Protocol Amendment, Deviations & How to Handle Protocol Failures and Investigations
Live Training Webinar
Date: Tuesday October 10, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar
Date: Wednesday October 11, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Fundamental Principles of Method Transfer: A Systematic Way to Qualify a New Lab to Perform Analytical Testing & A Review of USP <1224>
Live Training Webinar
Date: Tuesday October 17, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Laboratory Deficiencies and How to Minimize OOS/OOT
Live Training Webinar
Date: Wednesday October 18, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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 October 31, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
2023 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 November 1, 2023
Part 2: Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar - Date: Wednesday November 8, 2023
Part 3: Change Control for the Stability Program: GMP Requirements & Potential Risks Involved
Live Training Webinar - Date: Wednesday November 15, 2023
Part 4: A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar - Date: Wednesday November 29, 2023
Part 5: Developing and Validating Stability Indicating Methods to support Stability Program using Forced Degradation Studies
Live Training Webinar - Date: Wednesday December 6, 2023
Part 6: Design and Implement an Effective Stability Program to Support Marketed Products and Maintain Compliance to the Latest FDA, ICH and WHO Regulatory Requirements.
Live Training Webinar - Date: Wednesday December 13, 2023
FDA & International Stability Requirements in the Drug Development Process including WHO, ASEAN and ICH Q1AR2
Live Training Webinar
Date: Wednesday November 1, 2023 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar
Date: Wednesday November 8, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Change Control for the Stability Program, GMP Requirements & A Review of the Potential Risks Involved
Live Training Webinar
Date: Wednesday November 15, 2023 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar
Date: Wednesday November 29, 2023 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Developing and Validating Stability Indicating Methods to Support Stability Program Using Forced Degradation Studies
Live Training Webinar
Date: Wednesday December 6, 2023 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Design and Implement an Effective Stability Program to Support Marketed Products and Maintain Compliance to the Latest FDA, ICH and WHO Regulatory Requirements
Live Training Webinar
Date: Wednesday December 13, 2023 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba