Upcoming Interactive Live Webinar Training Programs:

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Additional live webinars are continuously added to this list for both 2018 as well as 2019. Please continue to check this list frequently for new updates.

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Industry Including a Review of the New 2018 MHRA Data Integrity Definitions & Guidances and the FDA’s Most Recent Draft Guidance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: Tuesday July 24, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Laboratory Quality Practices for Global Regulatory CMC Analytical Studies for Biotechnology/Biosimilar Products: R&D to GMP
Live Training Webinar - Date: Thursday July 26, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Nadine M. Ritter Ph.D.
Detailed Information>>>


Test Method Validation through the Test Method Lifecycle; Understanding the U.S. FDA and the EMA Guidance Documents and Why they Stress the Product Lifecycle Concept
Live Training Webinar - Date: Tuesday July 31, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Jerry Lanese Ph.D.
Detailed Information>>>


Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations
Live Training Webinar - Date: Tuesday August 7, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Jerry Lanese Ph.D.
Detailed Information>>>


Monitoring Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Date: Wednesday August 8, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba
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: Supply Chain Security – Understanding the Latest FDA, Canada and EU Regulatory Requirements
Live Training Webinar - Date: Wednesday August 15, 2018

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 August 22, 2018

2-Part Live Training Program Time: 9:30 - 11:30 AM ET (New York Time)

Detailed 2-Part Live Training Program Agenda>>>


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: Thursday August 16, 2018 - Time: 9:30 - 11:30 AM 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 23, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


2018 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 August 28, 2018

Part 2: Developing an Effective Method Validation Protocol
Live Training Webinar - Date: Tuesday September 25, 2018

Part 3 : Method Transfer: A Systematic Way to Quality New Lab to Perform Analytical Testing
Live Training Webinar - Date: Tuesday October 30, 2018

Part 4: Analytical Method Modification and Change Control Process
Live Training Webinar - Date: Tuesday November 27, 2018

Detailed 4-Part Live Training Program Agenda>>>


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: Wednesday August 29, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


2018 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 August 30, 2018

Part 2: The Manufacturing Environment
Live Training Webinar - Date: Thursday September 20, 2018

Part 3 : The Non-Sterile and Aseptic Fill ‘n Finish Environment
Live Training Webinar - Date: Thursday October 4, 2018

Detailed 3-Part Live Training Program Agenda>>>


2018 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 11, 2018

Part 2: Utilizing “Health-Based” Limits for Cleaning Validation; Practical Considerations in Implementing “Health-Based” Limits into Protocols
Live Training Webinar - Date: Thursday September 13, 2018

Part 3: Cleaning Validation; Dealing with “Indirect Product Contact Surfaces” and “Non-Product Contact Surfaces” & Regulatory Recommendations
Live Training Webinar - Date: Tuesday October 16, 2018

Part 4: Cleaning Validation; Issues in the Use of Total Organic Carbon (TOC) as an Analytical Technique
Live Training Webinar - Date: Thursday October 18, 2018

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 6, 2018

Part 6: Cleaning Validation; Design of Automated and Manual Cleaning Processes & Latest Regulatory Requirements
Live Training Webinar - Date: Thursday November 8, 2018

Part 7: Cleaning Validation: Issues in the Validation of Manual and Automated Cleaning Processes & Latest Regulatory References
Live Training Webinar - Date: Tuesday December 4, 2018

Part 8: Cleaning Validation: Dealing with Dedicated Equipment and with Campaigns
Live Training Webinar - Date: Thursday December 6, 2018

8-Part Live Training Program Time: 9:30 - 11:30 AM ET (New York Time)

Detailed 8-Part Live Training Program Agenda>>>


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: Wednesday September 12, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Current cGMP Compliance for In-House and Contract Analytical QC Laboratories: What is Expected and Inspected, and Why
Live Training Webinar - Date: Monday September 17, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Nadine M. Ritter Ph.D.
Detailed Information>>>


Quality Agreements (Final Guidance, Nov. 2016): Purpose, Scope, Organization, Common Issues & A Comprehensive Review of the 2018 FDA Regulatory Requirements
Live Training Webinar - Date: Tuesday September 18, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Detailed Information>>>


Latest FDA & International Stability Requirements in the Drug Development Process including WHO, ASEAN and ICH Q1AR2
Live Training Webinar - Date: Wednesday September 19, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Highlights of the Latest Critical WHO Guidances: A Need-to-Know for Global Product Development
Good Manufacturing Practices for Active Pharmaceutical Ingredients
Good Practices for Pharmaceutical Quality Control (QC) Laboratories
Good Data and Record Management Practices
Live Training Webinar - Date: Wednesday September 26, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


FDA New Guidance on Analytical Procedures and Method Validation for Drugs and Biologics
Live Training Webinar - Date: Tuesday October 2, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Anthony J. DeStefano 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 October 3, 2018 - Time: 9:30 - 11:30 AM 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: Thursday October 11, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Jerry Lanese Ph.D.
Detailed Information>>>


2018 Annual Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations Best Practices and FDA Latest Regulatory Requirements

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>>>


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: Tuesday October 23, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Anthony J. DeStefano Ph.D.
Detailed Information>>>


The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam
Live Training Webinar - Date: Wednesday October 24, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Barry Friedman Ph.D.
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>>>


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>>>


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>>>


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: 9:30 - 11:30 AM 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>>>


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 & 2018 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

8-Part Live Training Program Time: 9:30 - 11:30 AM ET (New York Time)

Detailed 8-Part Live Training Program Agenda>>>


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>>>


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>>>


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
3-Part Live Training Program Time: 9:30 - 11:30 AM ET (New York Time)

Detailed 3-Part Live Training Program Agenda>>>


Additional live webinars are continuously added to this list for both 2018 as well as 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.

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