Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 200

FDA/EU cGMP Compliance for Laboratories

Requirements and Tools for Implementation

Recorded

When drug companies develop products along the drug life cycle from research to development, clinical studies and manufacturing at at some point laboratories have to comply with GMP regulations. US and most international countries have GMP regulations that have specific sections for laboratories. However, regulations only tell you what to do but not how to implement. So there are many questions.

Key Questions related to cGMP compliant laboratories:

• What is the difference between GMP and Non-GMP laboratory
• What is the different between GLP and GMP requirements for laboratories
• What are the key GMP requirements for laboratories?
• Which procedures do we need?
• Which laboratory records should be retained for how long?
•  How to conduct failure investigations?
• What do FDA inspectors look at during inspections?
• How to prepare for an FDA or EU inspection
• What are the main deviations?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA and international regulations and guidelines
• FDA inspection and enforcement practices
• Major differences between GMP and non GMP laboratories
• Developing a laboratory compliance master plan
• Developing a project plan for step-by-step implementation
• Implementing key requirements
  - writing GMP compliant laboratory SOPS, training
  - correct sampling and sample handling
  - qualification and maintenance of equipment, validation of software and computers
  - validation of analytical methods, system suitability testing
  - handling out-of-specification situations, preventive and corrective actions
  - qualification of reference material
  - acquisition, maintenance and archiving of records
• Preparation for FDA inspections
• Recommendations for implementation

And for easy and instant implementation:
download 10+ documents from special seminar website

• Laboratory compliance master plan
• Project plan - Laboratory compliance: Step by Step
•  SOPs:
  - Handling OOS results
  - Laboratory Failure Investigations
  - Generation and Maintenance of Laboratory SOPs
  - Validation of Analytical Methods
  - Qualification of Equipment
  - FDA Inspections: Preparation, Conduct, follow-up
  - Validation of Spreadsheet Applications
  - Change control of analytical equipment
  - Training of Laboratory Personnel
  - Auditing Analytical Laboratories
• Worksheets/Checklists/Examples
  - Laboratory Audits
• FDA Presentations and Reports
  - Laboratory inspections
• Drug cGMP Requirements for Laboratory Records
• Warning letters and/or Inspectional observations related to QC Laboratories
• FDA Guidance for Industry:
  Inspection of Quality Control Laboratories

Who should attend?

• FDA/EU regulated laboratories
• Analysts and lab managers
• QA managers and personnel
• Validation specialists
• Regulatory affairs
• IT professionals
• Human resources (HR) managers and staff
• Training departments
• Documentation department
• Consultants. teachers

How to order

Pick one of the options in the table that fits your needs. 

Recorded seminar - Web download 'Site' offer Multiple persons - single site Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site. Order includes all reference material.	US$ 399.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
Special offer for Labcompliance Usersclub Members Recorded Seminar- CD or Web download. Order includes all reference material. for Usersclub information and registration, click here	US$ 299.-

About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

1. Study the printed slide material
2. Watch the slides on a computer
3. Watch the slides on a video screen in a seminar room
4. Ask questions through email and web form

 

About Dr. Ludwig Huber

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.