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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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Online audio seminar 341

Auditing QC Laboratories for FDA Compliance

Learn how to use internal audits in preparation for regulatory inspections

Recorded, available with all reference material at any time

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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. The large number of recent QC related 483's and warning letters prove that companies have issues to comply with regulations. Auditing laboratories is an ideal tool to verify compliance of laboratory practices with regulations and to prepare your organization for regulatory inspections.

Key Questions related to audits of QC laboratories are:

  • How frequently should laboratories be audited?
  • Who should be the members of the audit team?
  • What does FDA require: Vertical or horizontal audits?
  • How to prepare for an audit?
  • How to conduct an 'FDA-inspection like' audit?
  • How to audit the laboratory quality system?
  • What are most frequently found FDA inspectional observations
  • What documents should be audited?
  • How to audit a laboratory quality system?
  • How to respond to audit reports with deviations
  • What are critical questions for sampling, sample handling, validation, testing, reporting and archiving of data?
  • How to effectively follow up to continually improve the laboratory system?
  • How to write an FDA compliant audit report?

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 and examples. After the seminar, an extensive list of reference material like SOPs, worksheets, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Why are internal audits important
  • FDA and international requirements for laboratory audits
  • FDA and EMA inspections as models for laboratory audits
  • Developing an SOP for 'FDA Inspection Like' audits
  • Developing an audit schedule
  • The audit team: members, tasks, responsibilities
  • Most critical audit areas based on risk assessment
  • Looking at the right documentation
  • Auditing the laboratory quality system
  • Audit items along the sample and data workflow from sampling to record archiving
  • Assessment through laboratory walkthrough
  • The importance of the exit meeting
  • Writing the audit report
  • Follow-up with corrective and preventive actions: Going through six case studies

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

  • Master Plan: Laboratory Compliance (53 pages)
    - The ideal document to prepare your laboratory for internal and external inspections and audits
  • SOP: Auditing Quality Control Laboratories
  • SOP: FDA Inspections - Preparation/Conduct/Follow-up
  • SOP: Multinational GMP Inspections - Preparation/Conduct/Follow-up
  • Checklist: Auditing Quality Control Laboratories
  • Regulatory reference documents:
    - FDA Drug cGMP: Requirements for Laboratory Records
    - FDA Drug cGMP: Requirements for Manufacturing Records
  • Literature Reference papers.
    - How to avoid FDA warning letters
  • FDA Presentations
    - Insight on FDA Inspections and Recommendations
    - The Inspection is Over – What Happens Next?
       Possible FDA Enforcement Actions
    - Writing An Effective 483 Response
    - Laboratory GMPs and Inspectional Issues: an FDA Perspective
  • Most frequently asked questions and answers: Laboratory Compliance
  • Ten case studies: How to avoid and respond to FDA inspectional observations and warning letters
  • Warning letters and Inspectional observations related to analytical and QC labs.
  • FDA guidance
    - Guide to Inspection of Pharmaceutical Quality Control Laboratories
  • PIC/S Guide
    - Inspection of Pharmaceutical Quality Control Laboratories
  • FDA Compliance Program Guidance Manual: Drug Manufacturing Inspections
  • SOP: PIC/S inspection report format, PI 013-3, 25 September 2007
  • FDA Inspection Presentations
    -- Insight on FDA Inspections and Recommendations
    - The Inspection is Over – What Happens Next?
       Possible FDA Enforcement Actions
    - Writing An Effective 483 Response
    - Laboratory GMPs and Inspectional Issues: an FDA Perspective

Comprehensive Quality Control Lab Audit Items

A comprehensive audit includes quality system and technical controls. FDA inspections will focus on high risk items. Attend seminar the to learn what to look at.

Who should attend?

  • Laboratory managers and supervisors
  • GMP auditors - Internal and external
  • QA managers and personnel
  • Analysts and other laboratory staff
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Consultants

Date, time and duration

Recorded seminar, available at any time with all reference material

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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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.