Audio Seminars

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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

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.     

 

  1. Writing Effective SOPs For Regulatory Compliance
    Content, format, approval, training and distribution.
    Thursday, June 26, 2008
  2. FDA/EU cGMP Compliance for Laboratories
    Requirements and Tools for Implementation
    Wednesday, July 2, 2008
  3. Out-of-Specification Data Trending
    GMP requirements and tools for implementation
    July 3, 2008
  4. Cost Effective Software and Computer System Validation
    Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5
    July 24, 2008

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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 (COTS)
  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

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

Single users

Registrants entitles single users to a phone connection. The user will get a phone number to call into the conference and a web address for downloading the handout and reference material.

Site users

Registration entitles the registrant to one telephone connection. The registrant can book a seminar/meeting/conference room and invite as many people as he/she wishes to listen to the seminar on a speakerphone. The registrant receives a website address for downloading the handout and reference material.

Corporate users

Registration entitles the company to five phone number connections at multiple sites. Designated employees can either attend as single users from their desk or employees from different sites can attend as teams from seminar/conference rooms

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

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 is multiple replay by single and multiple users.

Internet download

The download option includes the recorded seminar as MP3 file and is available for download approx. two working days after the seminar and at any time later. Ordering this option also includes access to the full reference material and to the Q&A session. The download option is available for single users and sites.

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.

Special Offers


Take full advantage of attractive volume discounts

Pricing for recorded audio seminars, includes access to seminar websites

  • Regular price: $349
  • Purchase of three: $942 (10% volume discount)
  • Purchase of five: $1482 (15% volume discount)
  • Purchase of 10: $2792 (20% volume discount)
  • Purchase of 20: $5235 (25% volume discount)
  • Purchase of 30: $7329 (30% volume discount)

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

For ordering, click here.

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