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All seminars come with 10+ best practice documents, such as SOPs, checklists, master plans

 

Electronic Records

 

Ensuring Data Integrity for FDA/EU Compliance
Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records
February 4, 2016

 

Using Electronic and Digital Signatures in Regulated Environments

Comply with FDA Part 11 and with international regulations and guidelines

Recorded, available at any time

 

Understanding and Implementing the New EU Annex 11

Prepare Yourself for the upcoming Inspections and Enforcement

Recorded, available at any time

 

How to Ensure Part 11 Compliant Integrity of Laboratory Data

Comply with new FDA inspection practices and EU Annex 11 requirements

Recorded, available at any time

 

Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

Recorded, available at any time

 

Understanding and Implementing the New Final EU Annex 11

Learn about specific requirements and get tools for implementation

Recorded, available at any time

 

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program (270)

Learn what the FDA is looking for and how to respond

Recorded, available at any time

Recorded

Learning from Recent Warning Letters Related to Computer Validation and Part 11 (277)

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available at any time

 

Electronic Raw Data in Regulated Environments

Definition, generation and archiving for FDA Part 11, HIPAA and SOX compliance

Recorded, available at any time

 

FDA's 21 CFR Part 11

Introduction and Strategies and Tools for Implementation

Recorded, available at any time

 

Cost Effective Electronic Data Archiving for FDA Compliance

Understanding and Implementing the New GAMP Guide

Recorded, available at any time

 

Electronic Audit Trails for FDA Compliance
Requirements - Design - Implementation - Validation - Documentation

Recorded, available at any time

 

FDA Compliant Electronic Records Management

Recorded, available at any time

 

Using the SAFE Standard for Digital Signatures

For legally enforceable IP Protection, Electronic Transactions and FDA Submissions

Recorded, available at any time

 

Auditing Computer Systems for Part 11 and Annex 11 Compliance

Prepare your organization for upcoming FDA and EU inspection

Recorded, available at any time

 

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded, available at any time

 

LABORATORIES

 

FDA Compliant HPLC Qualification and Performance Testing (

Learn how to select, conduct and document the right tests in the right sequence

Recorded, available at any time 

 

Laboratory Equipment Qualification according to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
Recorded

 

Elemental Impurities According to the Final USP Chapters 232/233 (311)

With updates on the new ICH Q3D Guide: Elements, Limits and Schedule

 

FDA Compliant Sampling and Sample Handling in Laboratories

Strategies to Avoid Sampling Errors and Ensure Sample Integrity

Recorded

 

Compliant Training for Laboratory Personnel (285)

What to train - How much to Train - How to Document Effectiveness

Recorded, available at any time 

 

Eight Steps for Cost-effective Laboratory Compliance (287)

With up-to-date overview, hot topics and trends. With tool kit for easy implementation

Recorded, available at any time 

 

Quality by Design (QbD) for  Development and Validation of Analytical Methods
Learn how to design robustness for easy transfer and to avoid OOS situations

Recorded, available at any time 

 

FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

Recorded, available at any time 

 

Good Laboratory Practice Regulations

Introduction and Strategies for Implementation

Recorded, available at any time 

 

Ensuring Integrity and Security of Laboratory Data

Comply with new FDA inspection practices and EU Annex 11 requirements

Recorded, available at any time 

 

Verification of Compendial Methods according to the New USP Chapter <1226>
Understand the new risk based approach and and get real world case studies for testing
Recorded, available at any time 

 

Understanding the Updated USP Chapters 232/233 for Metal Impurities

With SOPs and Case Studies for Easy Implementation

Recorded, available at any time 

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

Recorded, available at any time 

 

FDA Compliance for Biopharmaceutical Laboratories

Become familiar with FDA regulations and get tool kits for implementation

Recorded, available at any time 

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded, available at any time 

 

Transfer of Analytical Procedures According to the New USP Chapter <1224>

With SOPs, templates and examples for easy implementation

Recorded, available at any time 

 

Learning from Recent Warning Letters Related to Good Laboratory Practices

For Preparation of FDA and International GLP Inspections

Recorded, available at any time

 

GMP Compliance for Quality Control Laboratories: Step-by-Step

FDA Requirements and Tools for Implementation

Recorded, available at any time

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded, available at any time

 

System Suitability Testing for FDA and USP Compliance

With 10+ Best Practices for easy Implementation

Recorded, available at any time

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practice Guides for Easy Implementation

Recorded, available at any time

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded, available at any time

 

FDA/ICH Compliant Development and Validation of Stability Indicating Methods

Sample generation - method development - validation - documentation

Recorded, available at any time

 

Practical Risk Assessment in Laboratories: Step-by-Step

With Risk Master Plan, SOPs and Case Studies for Easy Implementation

Recorded, available at any time

 

GMP Compliance for Quality Control Laboratories: Step-by-Step

FDA Requirements and Tools for Implementation

Recorded, available at any time

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded, available at any time

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with FDA Part 11, the PIC/s Good Practice Guide and the EU Annex 11

Recorded, available at any time

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practice Guides for Easy Implementation

Recorded, available at any time

 

Stability Testing in Pharmaceutical and API Industry

Learn how to design, conduct and document studies for FDA and ICH

Recorded, available at any time

 

Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance

 

How to Efficiently Get ISO 17025 Accreditation

Step-by-step from the idea to cost-effective implementation

Recorded, available at any time

 

Understanding and Implementing ISO 17025

Requirements, Strategies and Tool Kits for Laboratory Accreditation

Recorded, available at any time 

 

Calibration and Qualification in Analytical Laboratories

With examples from planning to reporting

Recorded, available at any time 

 

Handling Out-of-Specification Tests Results and Failure Investigations

With case studies to avoid and respond to FDA 483's and warning letters

Recorded, available at any time 

 

FDA Compliant and Efficient HPLC Qualification and Testing

Learn how to select, conduct and document the right tests in the right sequence

 

How to Efficiently Build a GLP Laboratory

Step-by-step from design to cost-effective implementation

Recorded, available at any time 

 

Effective Gap Analysis for ISO 17025

With Practical Tools for Easy Implementation

Recorded, available at any time 

 

Measurement Uncertainty in Chemical Analysis

With tools to comply with ISO17025 Standard and FDA expectations

Recorded, available at any time 

 

Management and Validation of Computers for ISO 17025

Requirements, Recommendations and Tools for Implementation

Recorded, available at any time 

 

Traceability in Chemical Analysis

With strategies and tools for ISO 17025 and FDA Compliance

Recorded, available at any time 

 

Verification of Compendial Procedures according to the Updated USP Chapter <1226>

Understand the new risk based approach and and get real world case studies for testing

September 1, 2011 

 

Auditing Laboratories for FDA and ISO 17025 Compliance

Preparation - conduct - follow up - documentation

Recorded, available at any time 

 

Understanding USP Documents and Reference Standards

General Chapters, General Notices, Monographs, Forum, Reference Standards

Recorded, available at any time 

 

Validation and Part11 Compliance of Chromatographic Data Systems

With 10 Validation Examples: From planning to system retirement

Recorded, available at any time 

 

Residual Solvent Analysis According to USP <467>

Understanding and implementing the revised chapter

Recorded, available at any time 

 

Sampling and Sample Handling in Laboratories

Strategies for  FDA and ISO 17025 Compliance and Tools for Implementation

Recorded, available at any time 

 

Inspection of Pharmaceutical Quality Control Laboratories

Recorded, available at any time 

 

Validation of Automated Laboratory Systems

Recorded, available at any time 

 

Validation of Software and Computer Systems in Analytical Laboratories

Recorded, available at any time 

 

Increasing Productivity with Electronic Laboratory Notebooks

Selection, Implementation and Strategies for Compliance

Recorded, available at any time 

 

Software and Computer Systems

 

Learning from Recent Warning Letters Related to Computer Validation and Part 11 (277)

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available at any time

 

Qualification of Virtual Networks and Cloud Computing (284)

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

How to get the most out of Supplier Support  for Equipment and Computer Validation

Strategies for suppliers to maximize business and for users to minimize validation cost

Recorded, available at any time 

 

Cost Effective Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

Recorded, available at any time 

 

Cost Effective Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

Recorded, available at any time 

 

Validation of Computerized Laboratory Systems

Implementing the new GAMP Laboratory Systems Guide

Recorded, available at any time 

 

Validation of Software and Computer Systems in Analytical Laboratories

Recorded, available at any time 

 

IT Infrastructure and Network Qualification: Step-by-Step (276)
With Strategies and Tool Kit for Compliance and System Uptime
Recorded, available at any time 

 

Assessment of Software and Computer System Suppliers

Recorded, available at any time 

 

How to Avoid the Top 10 Worst Computer Validation Mistakes

Recorded, available at any time 

 

Validation of Configurable Off-the Shelf Computer Systems

Recorded, available at any time 

 

FDA Compliant Testing for Validation and Qualification

Recorded, available at any time 

 

Computer System Validation Master and Project Planning

Includes 10 SOPs and a master and project plan

Recorded, available at any time 

 

Computer System Validation

Requirements and strategies for implementation

Recorded, available at any time 

 

Understanding and Implementing the New EU Annex 11

Prepare Yourself for the upcoming Inspections and Enforcement

December 20, 2012

 

Validation and Use of Cloud Computing in FDA Regulated Environments

Comply with GXPs, Part 11, EU Annex 11 and other regulations

December 13, 2012

 

Configuration Management and Change Control of Computer Systems

Hardware - Firmware - Software - Networks

Recorded, available at any time 

 

Computer System Validation for GLP

How much is enough?

Recorded, available at any time 

 

Retirement of Computer Systems

Strategies for FDA Compliance and Tools for Implementation

Recorded, available at any time 

 

FDA's New Guidance on using Computers for Clinical Trials

Understanding FDA's New Approach Towards Computer Systems

Recorded, available at any time 

 

Validation and Use of MS Access™ Databases in GxP and Part11 Environments

Recorded, available at any time 

 

Validation and Part11 Compliance of Chromatographic Data Systems

With 10 Validation Examples: From planning to system retirement

Recorded, available at any time 

 

Validation and Part 11 Compliance of Electronic Document Management Systems

With Validation Examples: From planning to system retirement

Recorded, available at any time 

 

Contingency and Disaster Recovery Planning for Computer Systems (197)
To Ensure Business Continuity and Compliance

Recorded, available at any time 

 

Cost Effective Software and Computer System Validation

Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5

Recorded, available at any time 

 

Writing Effective Test Scripts and Validation Protocols for the Bio/Pharmaceutical Industry

Recorded, available at any time 

 

Validation of Existing/Legacy Computer Systems

FDA/EU requirements and strategies and tools for implementation

Recorded, available at any time 

 

Auditing Computer Systems in Manufacturing and Laboratories

For Validation and Part 11 Compliance in Pharmaceutical and Device Industries

Recorded, available at any time 

 

Master Planning for Software and Computer Validation

With examples for master and several project plans

 

Requirement Management for Equipment and Computer Systems

Strategies for Development, Documentation and Updates or Requirement Specifications

Recorded, available at any time 

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

With FDA's Dennis Cantellops as Guest Speaker
Comply with GxPs, Part11, HIPAA, SOX and other regulations.

Recorded, available at any time 

 

Risk Based Validation of Software and Computer Systems

Strategies for FDA/EU Compliance and Tools for Implementation

Recorded, available at any time 

 

Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

Recorded, available at any time 

 

Simplify Validation and Qualification with ASTM E2500

Cost Effective Alternative for Equipment Qualification and System Validation

Recorded, available at any time 

 

How much Validation is Enough?

Developing a Company Wide Strategy and Tools for Cost-effective Implementation

Recorded, available at any time 

 

Validation of Excel® Spreadsheets for Regulated Environments: Step-by-Step

With Case Studies and Validation Protocols for Easy Implementation

Recorded, available at any time 

 

Understanding and Implementing the New Final EU Annex 11

Learn about specific requirements and get tools for implementation

Recorded, available at any time 

 

Auditing Computer Systems for Part 11 and Annex 11 Compliance

Prepare your organization for upcoming FDA and EU inspection

Recorded, available at any time 

 

Validation and Use of Excel® Spreadsheets in Regulated Environments Comply with FDA Part 11, the PIC/s Good Practice Guide and the EU Annex 11

Recorded, available at any time 

 

Cost Effective Approach to Achieve FDA Compliance

  • No travel - No lost time - Get compliance solutions fast
  • Just download the presentation and other reference material, dial in or listen to the recorded seminar and get advise from the world experts!
  • Use the 10+ seminar tool kit for easy implementation: SOPs, examples, templates, checklists
  • Attend one of the upcoming life seminars or learn from over  70 recorded seminars

Overview

The presenter and guest speakers may be in any part of the world as long as they have access to a phone. Attendees listen on the phone either as single persons at their desk or together with colleagues in a seminar or conference room. Slides and other material can be downloaded from a special website site and viewed either as printouts or an computer or video screen. Before, during and after the seminar attendees can ask questions either life or through web forms.

The seminars are recorded and are available either as CD or as Web Download. Orders of recorded seminars include all reference material

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Upcoming Seminars

Times:

North America: ET 11 a.m. (e.g., Washington D.C.), CT 10 a.m. PT 8 a.m.
Europe: CET 5 p.m. (Paris/Berlin)
Check: www.timeanddate.com/worldclock/  for you local time.

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Recorded Seminars by Topics

General Compliance/Inspections

Equipment Qualification

Software/Computer Validation

Network/Internet compliance

Electronic records/electronic signatures

Laboratories

Failure Investigation/OOS/CAPA, Root Cause Analysis

Manufacturing

Recorded Seminars by Seminar Number

All seminars include

  • The audio file is available either on CD or as web download
  • Orders include reference materials on a dedicated website for instant download
  1. Strategies for Cost Effective Network Compliance and System Uptime
  2. Using Excel® in Part11/GxP Regulated Environments
  3. The Ultimate Answers and Tools You Need to Define and Document Your Part 11 Scope and Controls
  4.  FDA's 21 CFR Part 11: Requirements, New Scope and Recommendations for Implementation
  5. Design and Validation of Spreadsheets for Part 11 and GxP Compliance
  6. Validation of Computerized Laboratory Systems Implementing the new GAMP Laboratory Systems Guide
  7. Successful FDA Inspections: Preparation - Conduct - Follow Up
  8. Effective Training for FDA Compliance
  9. Risk Based Computer Validation and Part 11 Compliance
  10. Configuration Management and Change Control of Software and Computer Systems
  11. Writing Effective SOPs for the Healthcare Industry
  12. Validation of Software and Computer Systems in Analytical Laboratories
  13. Effective Master Planning for Computer Validation
  14. Laboratory Equipment Qualification
  15. Writing Effective Test Scripts and Validation Protocols for the Bio/Pharmaceutical Industry
  16.  Audits of Computer Systems in Laboratories and Manufacturing
  17. Strategies to Implement FDA's New Quality System Guide
  18. Validation and Use of Excel Spreadsheets in GxP and Part 11 Environments
  19. Eight steps for cost-effective Software and Computer Validation
  20. Using Internet and Intranet in FDA/EU Regulated Environments
  21. How to Comply with International GMP Regulations and Guidelines
  22. Assessment of Software and Computer System Suppliers
  23. Managing OOS and Corrective/Preventive Actions
  24. How to Avoid the Top 10 Worst Computer Validation Mistakes
  25. Network Infrastructure Qualification - Introduction and strategies for compliance and system uptime
  26. How to define User Requirement Specifications for Computer Systems
  27. 21 CFR Part 11 - Electronic Records and Electronic Signature
  28. Electronic Raw Data in FDA Regulated Environments
  29. Risk Management for FDA/EU Regulated Industries Introduction and Strategies for Compliance and Trouble-free Operation
  30. Managing Failure Investigations and OOS Situations
  31. Strategies for an Effective Root Cause Analysis and CAPA Program
  32. Analytical Instrument Qualification (AIQ)
  33. Using Excel in Regulated Environments
  34. FDA Compliant Electronic Records Management
  35. FDA/EU Compliance in Analytical Laboratories
  36. Validation of Configurable Off-the Shelf Computer Systems
  37. FDA Compliant Testing for Validation and Qualification
  38. Change Control for Computer Systems
  39. Inspection of Pharmaceutical Quality Control Laboratories
  40. Developing a Validation Master Plan for Pharmaceutical Manufacturing
  41. Validation of Automated Laboratory Systems
  42. Validation of Analytical Methods and Procedures
  43. Documentation for GxP Compliance
  44. Computer System Validation Master and Project Planning
  45. Network Infrastructure Qualification
  46. Increasing Productivity With Electronic Laboratory Notebooks
  47. Risk Based Validation of Software and Computer Systems
  48. Effective GxP Training Practices
  49. Using the SAFE Standard for Digital Signatures
  50. Using the Internet in Regulated Environments
  51. Validation and Use of MS Access™ Databases in GxP and Part11 Environments
  52. How to Prepare Your Organization for the 'New' Part 11
  53. Good Laboratory Practices
  54. Current Good Manufacturing Practices
  55. Equipment Qualification
  56. Computer Validation
  57. Preventing and Handling Security Incidents
  58. Raw Data in FDA/EU Regulated Environments
  59. Auditing Analytical Laboratories for FDA Compliance
  60. Risk Management for Laboratory Systems
  61. Managing OOS Test Results and Failure Investigations
  62. Validation and Use of Excel® Spreadsheets in Regulated Environments
  63. Analytical Instrument Qualification (AIQ) According to USP Chapter <1058>
  64. Configuration Management and Change Control for Computer Systems
  65. FDA Compliant Standard Operating Procedures
  66. Learning from Laboratory Related Warning Letters
  67. Computer System Validation for GLP
  68. How to Comply with International GMP Regulations
  69. Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
  70. Retirement of Computer Systems
  71. Verification of Compendial Methods
  72. Electronic Raw Data in FDA Regulated Environment
  73. IT Infrastructure and Network Qualification
  74. Implementing FDA's 'New' 21 CFR Part 11
  75. Risk Based Computer Validation for Highest Efficiency and FDA Compliance
  76. Transfer of Analytical Methods and Procedures
  77. FDA's New Guide on Using Computerized Systems in Clinical Investigations
  78. Validation and Use of MS Access™ Databases in GxP and Part11 Environments
  79. Good Laboratory Practice Regulations
  80. Using the Internet and Intranet in Regulated Environments
  81. Documentation for FDA Compliance
  82. Electronic Audit Trails for FDA Compliance
  83. Validation and Part11 Compliance of Chromatographic Data Systems
  84. Cost Effective Electronic Data Archiving for FDA Compliance
  85. Managing OOS, Failure Investigations, and CAPA
  86. Validation and Part 11 Compliance of Electronic Document Management Systems
  87. Validation and Use of Excel® Spreadsheets in Regulated Environments
  88. System Suitability in Chromatographic Compendial Methods (188)
  89. Understanding and Implementing ISO 17025
  90. Validation of Analytical Methods and Procedures
  91. Understanding USP Documents and Reference Standards (191)
  92. Understanding the New USP <1058> for Analytical Instrument Qualification
  93. Learning from Recent FDA Warning Letters Related to Computer Systems and Part 11
  94. Selection and Use of (Certified) Reference Material
  95. Sampling and Sample Handling in Laboratories
  96. Development and Validation of Stability Indicating Methods
  97. Contingency and Disaster Recovery Planning for Computer Systems (197)
  98. Writing Effective SOPs For Regulatory Compliance
  99. Understanding and Implementing the New EU Annex 11
  100. FDA/EU cGMP Compliance for Laboratories
  101. Out-of-Specification Data Trending
  102. Cost Effective Software and Computer System Validation
  103. FDA Globalization Act of 2008: More Fees, More Inspections
  104. Effective Training Practices for FDA Compliance
  105. Test Scripts and Protocols for Equipment and Computer Validation
  106. Residual Solvent Analysis According to USP <467>
  107. Validation of Existing/Legacy Computer Systems
  108. Bioanalytical Method Validation
  109. Raw Data in FDA Regulated Environments
  110. Effective Gap Analysis for ISO 17025
  111. Auditing Computer Systems for FDA and EU Compliance
  112. Master Planning for Software and Computer Validation
  113. Requirement Management for Equipment and Computer Systems
  114. Validation and Use of Excel® Spreadsheets in Regulated Environments
  115. Measurement Uncertainty in Chemical Analysis
  116. Management and Validation of Computers for ISO 17025
  117. IT Infrastructure and Network Qualification
  118. Traceability in Chemical Analysis
  119. Effective Verification of Compendial Methods
  120. Risk Based Validation of Software and Computer Systems
  121. Latest Updates for Computer Validation and Part 11 Compliance
  122. Auditing Laboratories for FDA and ISO 17025 Compliance
  123. Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
  124. Understanding and Implementing ISO 17025
  125. Six Steps to Successful FDA GMP Inspections
  126. Calibration and Qualification in Analytical Laboratories
  127. Handling Out-of-Specification Tests Results and Failure Investigations
  128. FDA Compliant HPLC Qualification and Performance Testing
  129. How to Efficiently Build a GLP Laboratory   
  130. FDA's New Enforcement of 21 CFR Part 11
  131. FDA Compliant Transfer of Analytical Methods
  132. Computer System Validation: Step-by-Step
  133. Stability Testing in Pharmaceutical and API Industry (233)
  134. Validation of Analytical Methods and Procedures (234)
  135. Validation and Use of Excel® Spreadsheets in Regulated Environments (235)
  136. Simplify Validation and Qualification with ASTM E2500 (236)
  137. How to Efficiently Get ISO 17025 Accreditation (237)
  138. Documentation for FDA and ISO 17025 Compliance (238)
  139. Qualification and Calibration of Stability Chambers (239)
  140. Analysis of Metal Impurities According to New USP Chapters (240)
  141. The Qualified Person in the Pharmaceutical Industry (241)
  142. Practical Risk Assessment in Laboratories: Step-by-Step
  143. FDA's 21 CFR Part 11
  144. How much Validation is Enough?
  145. Implementing FDA's 21 CFR 111 for Dietary Supplements  
  146. Electronic Raw Data in Regulated Environments
  147. GMP Compliance for Quality Control Laboratories: Step-by-Step
  148. Analytical Instrument Qualification According to USP <1058>
  149. Recent Warning Letters and 483's Related to Computer Validation and Part11      
  150. Understanding and Preparing for FDA's New Part 11 Inspection Program
  151. System Suitability Testing for FDA and USP Compliance
  152. FDA Regulations for (Bio)Pharmaceutical Industry
  153. FDA Compliant Use of (Certified) Reference Material
  154. Effective HPLC Method Development and Validation
  155. Validation of Excel® Spreadsheets: Step-by-Step
  156. How to Prepare Yourself for FDA's New Part 11 Inspection Program
  157. Validation of Existing/Legacy Computer Systems for FDA/EU Compliance
  158. Revalidation of Computer Systems for FDA&EU Compliance
  159. FDA/ICH Compliant Development and Validation of Stability Indicating Methods
  160. Learning from Recent Warning Letters Related to Good Laboratory Practices
  161. Understanding and Implementing the New Final EU Annex 11
  162. Transfer of Analytical Procedures According to the New USP Chapter <1224>
  163. Learning from Recent Warning Letters Related to GMP Laboratory Controls
  164. Auditing Computer Systems for Part 11 and Annex 11 Compliance
  165. Validation and Use of Excel® Spreadsheets in Regulated Environments
  166. Developing a Risk Management Master Plan
  167. Raw Data in FDA Regulated Environments
  168. FDA Compliance for Biopharmaceutical Laboratories
  169. Validation of Bioanalytical Methods and Procedures
  170. How to Prepare Yourself for FDA's on-going Part 11 Inspection Program
  171. Periodic Review and Evaluation of Computer Systems
  172. Understanding the Updated USP Chapters 232/233 for Metal Impurities
  173. Verification of Compendial Procedures according to the Updated USP Chapter <1226>
  174. Ensuring Integrity and Security of Laboratory Data
  175. Good Laboratory Practice Regulations
  176. IT Infrastructure and Network Qualification: Step-by-Step
  177. Learning from Recent Warning Letters Related to Computer Validation and Part 11
  178. How to get the most out of Supplier Support  for Equipment and Computer Validation
  179. Cost Effective Computer System Validation: Step-by-Step
  180. Validation of Analytical Methods and Procedures
  181. FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
  182. FDA Compliant SFC Qualification and Performance Testing
  183. Quality by Design (QbD) for  Development and Validation of Analytical Methods
  184. Qualification of Virtual Networks and Cloud Computing
  185. FDA/EU Compliant Training for Laboratory Personnel (285)
  186. Implementing the New USP Chapter <1224> for Analytical Method Transfer
  187. Eight Steps for Cost-effective Laboratory Compliance
  188. FDA Compliant Sampling and Sample Handling in Laboratories
  189. How to Survive FDA's 'New' Inspection and Enforcement Practices
  190. Ensuring Integrity and Security of Electronic Records for FDA Compliance
  191. Configuration Management and Change Control for Networks and Computer Systems
  192. Validation and Use of Excel Spreadsheets in Regulated Environments
  193. Selecting Acceptance Criteria for Regulatory Method Validation
  194. Qualification and Use of Virtual Networks in Regulated Environments
  195. Implementing the New USP Chapters 232/233 for Elemental Impurities
  196. Verification of Compendial Methods according to the Revised USP Chapter <1226>
  197. FDA Compliant Use of (Certified) Reference Material
  198. Laboratory Equipment Qualification according to USP <1058>
  199. Calibration and Qualification of Stability Chambers  
  200. Cost Effective Validation of Laboratory Computer Systems
  201. Using Electronic and Digital Signatures in Regulated Environments
  202. Validation of Analytical Methods for GLP and Clinical Studies
  203. Validation and Use of Cloud Computing in FDA Regulated Environments
  204. Understanding and Implementing the New EU Annex 11
  205. FDA Compliant IT Infrastructure and Network Qualification
  206. Quality by Design (QbD) for Analytical Method Development and Validation
  207. Efficient Training Practices for FDA and International Compliance
  208. How to Effectively Build a GLP Laboratory
  209. Setting up a Quality System for Pharmaceutical Laboratories
  210. Transfer of Analytical Procedures According to the New USP Chapter <1224>
  211. Elemental Impurities According to the Final USP Chapters 232/233
  212. Comparing GLP with GMP
  213. FDA/EMA Compliance for Genotoxic Impurities
  214. How to Ensure Part 11 Compliant Integrity of Laboratory Data
  215. Regulatory Aspects of Biosimilar Biological Products
  216. Validation and Use of Excel Spreadsheets in Regulated Environments
  217. Validation and Use of Cloud Computing in FDA Regulated Environments
  218. FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
  219. Basic and update Training on Good Manufacturing Practices
  220. System Suitability Testing for FDA and USP Compliance (320)
  221. Integrated Analytical Equipment Qualification and System Validation for FDA Compliance
  222. Managing Electronic Raw Data in Regulated Environments
  223. FDA Compliant Use of (Certified) Reference Material
  224. Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines
  225. Quality by Design (QbD) for Development and Validation of Analytical Methods
  226. GMP Compliance for Quality Control and Contract Laboratories
  227. Are You ready for FDA's 'New' Inspection and Enforcement Practices?
  228. Understanding FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
  229. Transfer of Analytical Methods According to the New USP Chapter <1224>
  230. Understanding the 'New' FDA Guide for Validation of Bioanalytical Methods
  231. FDA/EU Compliant IT Infrastructure and Network Qualification 
  232. Validation and Use of Cloud Computing in FDA Regulated Environments 
  233. Laboratory Equipment Calibration and Qualification according to USP <1058>
  234. Understanding the New EU-GMP Annex 15 on Validation and Qualification
  235. Understanding Quality by Design for the Pharmaceutical Industry
  236. Validation of Analytical Methods according to the New FDA Guidance
  237. Impact of Quality by Design on the Analytical Laboratory
  238. Comparing GLP with GMP
  239. Recent Regulatory Updates in Pharma and Biopharma Compliance
  240. Validation and Control of Excel Spreadsheets for FDA Compliance
  241. Auditing QC Laboratories for FDA Compliance
  242. Effective Validation of Analytical Methods for GLP and Clinical Studies
  243. Handling Out-of-Specification Tests Results and Failure Investigations
  244. Learning from Recent Warning Letters Related to Computer Validation and Part 11
  245. Computer System Validation: Step-by-Step
  246. Review of Analytical Methods as Alternative to regular Revalidation
  247. Managing Out of Trend Results in Pharmaceutical Quality Control
  248. New OECD Guide: Using Computer Systems in GLP Studies
  249. FDA Compliant HPLC Qualification and Performance Testing
  250. Understanding and Implementing the New EU Annex 11
  251. Validation and Use of Cloud Computing in FDA&EU Regulated Environments
  252. Risk Based Validation of Computer Systems and Part 11 Compliance
  253. Ensuring Data Integrity for FDA/EU Compliance
  254. Quality by Design (QbD) for Development and Validation of Analytical Methods
  255. FDA/EU Compliant Handling of OOX Test Results
  256. Lessons from Recent Quality Control Lab related FDA Warning Letters
  257. FDA/EU Compliant Use of (Certified) Reference Material
  258. FDA Compliant IT Infrastructure and Network Qualification
  259. Implementing the New Final EU-GMP Annex 15 on Validation and Qualification
  260. Managing Electronic Raw Data in Regulated Environments
  261. New Official Guidelines and Trends in Analytical Method Validation and Transfer (361)
  262. Qualification of Virtual Networks and Cloud Computing
  263. Analytical Instrument Qualification According the new Revision of USP <1058>
  264. FDA's New Enforcement of Part 11
  265. Understanding the Final FDA Guidance for Validation of Analytical Methods
  266. Ensuring Integrity of Laboratory Data for FDA/EU Compliance
  267. Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines
  268. Learning from Recent Warning Letters related to Part 11 and Computer Validation
  269. Ensuring Data Integrity for FDA/EU Compliance
  270. Quality by Design (QbD) for Development and Validation of Analytical Methods
  271. Understanding the New FDA Data Integrity Guidance
  272. Understanding the new Revision of USP <1058>
  273. Integrity of Laboratory Data for FDA/EU Compliance
  274. FDA Compliant IT Infrastructure and Network Qualification
  275. Understanding the Final FDA Guidance for Validation of Analytical Methods
  276. Quality by Design (QbD) for Development and Validation of Analytical Methods
  277. Integrity of Laboratory Data for FDA/EU Compliance

Benefits for companies and attendees

  • No traveling inconvenience - saves time and money
  • Single attendees can attend from the convenience of their desk.
  • Multiple attendees can share a seminar/conference room and discuss the outcome

Registration for Life Seminars

Standard Offer: This option allows single users to attend

Site Offer: This option allows an unlimited number of users at a site to attend, e.g., in a seminar room,

Computer equipment: Internet and email connection, PowerPoint Software, Word software

Procedure
Three days before seminar the user(s) will get a phone number to call into the conference and a web address for downloading the PowerPoint presentation and other reference material such as SOPs, checklists and others. About 3 minutes before the seminar start attendees call the service phone number and view the PowerPoint slides along with the seminar. All reference material as advertised is available for download from a reference website for at least a year and will be updated if new material comes up. Before, during and after the seminar attendees can ask questions. All Q&As will also be posted on the reference website.

Ordering Recorded Seminars

For recorded seminars we offer several options. All options include access to the full reference material and to the Q&A session.

CD offer

The CD includes the recorded seminar and is available for shipment approx. a week after the seminar. Ordering the CD also includes access to the full reference material and to the Q&A session. CD's can be used by all users at one site. Ordering is possible at the day of the seminar announcement and any time later. Benefits of this option are multiple replay by single and multiple users.
Computer equipment: Internet and email connection, PowerPoint Software, Word software. CD drive.

Download offer

The download option includes the recorded seminar as MP3 file in addition to all other reference material and and is available for single or multiple downloads from approx. two working days after the seminar for at least a year. Ordering this option also includes access to the full reference material and to the Q&A session.
Computer equipment: Internet and email connection, PowerPoint Software, Word software. MP3 3 player, e.g., MS Media viewer (included for free in MS Operating systems).

Special Offers

Discount for Usersclub members

Members of the Labcompliance Usersclub get a discount of up to $100 for each seminar

Custom offer

If none of the above option fits you needs, Labcompliance is flexible enough to customize the audio seminar for one-on-one sessions, site or corporate sessions. It is also possible to set up seminars on specific topics that are of interest for your company. The best way to look at the competence of Labcompliance would be to look at the topics presented at national or international conferences. For special quote contact Labcompliance Reference: Custom offer. Please specify your specific requirements.

Volume Discount

Take full advantage of attractive volume discounts for CD and Download versions

Pricing for recorded audio seminars, includes access to seminar websites

  • Regular price: $399
  • Purchase of three: $1078 (10% volume discount)
  • Purchase of five: $1695 (15% volume discount)
  • Purchase of 10: $3192 (20% volume discount)
  • Purchase of 20: $5985 (25% volume discount)
  • Purchase of 30: $8379 (30% volume discount)

User club members will get an additional discount of $200.

If you are interested please send an e-mail to

info@labcompliance.com

Subject: Multiple Seminars

please specify: 

  1. Seminar numbers
  2. Download or CD version
  3. Method of payment:  credit card, check, bank transfer

Tool Kits

Each seminar includes a tool kit for easy implementation of seminar topics. Examples are:

  • Master plans
  • Primers
  • Checklists
  • SOPs
  • Templates
  • Examples
  • Reference papers
  • FDA presentations
  • FDA warning letters
  • FDA inspection reports and warning letters,

Frequently Asked Questions

Question:

How long does one seminar last?

Answer:

Typically one hour.


Question

Is this the same as a web seminar?

Answer

It is not what you call a web seminar but it has similar or better features, benefits and advantages. In a web seminar typically you need a computer, an internet connection and a phone line at the same time to view the slides and listen to the sound. With audio seminars you always can download the slides prior to the seminar and you can view the slides and listen on a phone independent from an internet connection. In addition you get a lot of reference material that you can use as a pre-study, so you are much better prepared.

 

Question

Can I ask questions during the seminar?

Answer

Yes, you can ask questions and make comments by e-mail before, during and after the seminar. For e-mails you can either use the form on the website or you can send an e-mail to huber@labcompliance.com. You also can ask questions over the during the seminar.

Question

What is the difference between site option and CD

Answer

Most important: Information: you get is exactly the same on CD and as recorded site option. Both include access to the same reference material. Both options include the recorded seminar, so you or your colleagues can listen as many times as necessary. And you acn use the web form to ask questions. CD takes about a week for shipment. With the recorded site option you can download the seminar right after payment has received.

 

Question

Can attendees get access to all questions and answers?

Answer

Yes, they are posted at the seminar website around 2-3 days after the seminar.

 

Question

Can we ask questions anonymously?

Answer

Usually we don't mention your name and company when we answer your question life or on the website.

 

Question

Is there a script for the seminar?

Answer

Yes, for most of them, not for all. If available, scripts are posted at the seminar website about two weeks after the seminar

 

Question

Are the telephone costs included in the seminar fee?

Answer

No, they are not.

 

Question

I have missed a seminar but I am interested to get this information?

Answer

All seminars are recorded so you can go back to the overview page and select the seminar you are interested. You can either order a CD or you can order an Internet download. The file format for the downloads is MP3 and you get the recorded seminar faster, however, the quality of the CD is slightly better.

 

Question

Do the recorded seminars include all the hand-outs?

Answer

Yes. When you purchase any recorded seminar option, you get access to the same website as for the live session. This includes all handouts.

 

Question

Can I ask questions when I order a recorded seminar?

Answer

Yes. Either use the form on the seminar website or send an e-mail to huber@labcompliance.com with Re: Audio-Number or Title

 

Question

I am a member of the Labcompliance Usersclub. Can I get a special discount?

Answer

Yes, Usersclub members get a special discount. see the seminar websites for more information. 

 

Question

Hello, the materials are wonderful, however I was unable to save the pdf files on my hard drive. Any recommendations? Thank you.

Answer

This function is common to all files, when you open them and hit 'File' on upper left corner, the 'save' functions are blanked out. You need to click on the little disc and then it works. Or you don't open at all but hit the right mouse button and save on any directory.


Question

Can I order just the handout without registering for the seminar.

Answer

We do not offer such package. The individual SOPs can be ordered from: www.labcompliance.com/solutions/sops the examples

www.labcompliance.com/solutions/examples

 

Question

Can I print the slides.

Answer

Yes, you can print the slides. The slides are Powerpoint presentations. If you don't have Powerpoint, we can send you PDF files.

 

Question

Can I save the slides on the computer.

Answer

Yes, you can download the file from the reference website and save  iton the computer hard disk or on any other storage device.

 

Question

What is the content of the recorded CD

Answer

The CD includes the audio file to replay the seminar. It also has a link to a web address where you download all reference material as advertised including the presentation

 

Question

What iarethe edition dates of the seminars

Answer

See the list below. The seminar numbers are included in the seminar list on

www.labcompliance.com/seminars/audio  and on each seminar page.

101-118 2004
119-136 2005
137-161 2006
162-188 2007
189-211 2008
212-231 2009
232-258 2010
259-281 2011
282-304 2012
305-327 2013
328-350 2014