Upcoming Live Training Programs by Kim Huynh-Ba :

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

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

Part 1: Developing an Effective Method Validation Protocol
Live Training Webinar - Date: Tuesday September 25, 2018

Part 2: Method Transfer: A Systematic Way to Quality New Lab to Perform Analytical Testing
Live Training Webinar - Date: Tuesday October 30, 2018

Part 3: Analytical Method Modification and Change Control Process
Live Training Webinar - Date: Tuesday November 27, 2018

Detailed 3-Part Live Training Program Agenda>>>


Developing an Effective Method Validation Protocol
Live Training Webinar - Date: Tuesday September 25, 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 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 17, 2018

Part 2: Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar - Date: Wednesday October 31, 2018

Part 3: Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar - Date: Wednesday November 28, 2018

Part 4 : Laboratory Deficiencies and How to Minimize OOS/OOT
Live Training Webinar - Wednesday December 5, 2018

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 17, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Method Transfer: A Systematic Way to Quality New Lab to Perform Analytical Testing
Live Training Webinar - Date: Tuesday October 30, 2018 - Time: 9:30 - 11:30 AM 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 31, 2018 - Time: 9:30 - 11:30 AM 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 27, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


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>>>


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>>>


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>>>


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 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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>>>


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>>>


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>>>


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>>>


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>>>