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All documents shown here are included in the seminar for instant download

FDA Presentation:

Laboratory Inspections

Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them

Links to GMP regulations and guidelines with impact on Quality Control Laboratories

US FDA, EU, PIC/S, WHO, ICH

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
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On-line Audio Seminar 247

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

FDA/EMA Requirements and Tools for Cost Effective Implementation

Recorded

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Quality control laboratories are considered high risk because after testing and approval pharmaceutical drug products and APIs are released to the market without further check. That's the reason why FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation.

Key Questions related to GMP compliance in QC laboratories:

  • What is the difference between GMP and Non-GMP laboratories?
  • What is the different between GLP and GMP requirements for laboratories?
  • What is FDA's focus during inspections?
  • What are the key GMP requirements for laboratories?
  • Which procedures do we need?
  • Which laboratory records should be retained for how long?
  • How to handle out-of-specification test results?
  • What do FDA inspectors look at during inspections?
  • How to prepare for an FDA or EU inspection?
  • What are the typical deviations found during inspections and how to avoid them?

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 master plans, SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and international regulations and guidelines
  • Most frequently found deviations during inspections
  • Major differences between GMP and non GMP laboratories
  • Compliance along the laboratory workflow
  • Developing a laboratory compliance master plan
  • The importance of a compliance team
  • 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 analytical methods,
    - handling out-of-specification situations, preventive and corrective actions
    - qualification of suppliers and 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
  • Laboratory compliance: Step by Step
  •  SOPs:
    - Handling OOS results
    - Laboratory Failure Investigations
    - Conducting Management Reviews
    - Generation and Maintenance of Laboratory SOPs
    - Validation of Analytical Methods
    - FDA Inspections: Preparation, Conduct, follow-up
    - Change Control of Analytical Equipment
    - Training of Laboratory Personnel
    - Auditing Analytical Laboratories
  • Worksheets/Checklists/Examples
    - Laboratory Audits
  • FDA Presentation
    - Laboratory inspections
  • Regulatory Reference Document
    - FDA cGMP Requirements for Laboratory Records
  • Warning letters and/or Inspectional observations related to QC Laboratories
  • FDA Guidance for Industry:
    Inspection of Quality Control Laboratories
  • PIC/S Training Guide for Inspectors: Inspections of QC 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

Date, time and duration

Order at any time, replay at any time, download the reference material at any time.

How to order

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

Recorded seminar - Web Download

  • 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.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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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.-
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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 editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

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 visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.