Labcompliance Video Seminar 105

Video clips are recorded and imbedded in PowerPoint presentation slides. This allows highest flexibility. For example slides and clips can be skipped or replayed several times. The PowerPoint presentation with video clips come on a CD or as web download. Reference material such as 10+ best practice documents can be downloaded from a password protected website. The site and its updates can be accessed for two years.

Video Seminar 105

Auditing Analytical Laboratories for FDA Compliance

Preparation - conduct - follow up - documentation

With Dr. Ludwig Huber

Auditing laboratories is necessary to verify compliance of laboratory practices with regulations, with external and internal quality standards and with internal procedures. When done right, for example, with appropriate feedback and follow-up, audits can also help to improve the quality and efficiency of laboratory operations.

Key Questions related to FDA compliance are:

• Who should audit laboratories?
• How frequently should laboratories bee audited?
• What are the responsibilities of the audit team?
• What does FDA require: Vertical or horizontal audits?
• What are most critical audit questions?
• How to prepare for an audit?
• How to conduct an audit?
• What documents should be audited?
• How to effectively follow up?
• How to audit a laboratory quality system?
• What are critical questions for sampling, sample handling, testing, reporting and archiving of data?
• 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:

• Three good reasons for laboratory audits
• FDA and international requirements for laboratory audits
• FDA Inspections as model for laboratory audits
• Developing an SOP for 'FDA Inspection Like' audits
• Developing an audit schedule
• The audit team: members, tasks, responsibilities
• Selecting most critical areas
• Looking at the right documentation
• Looking at critical laboratory subsystems
• Assessment through laboratory walkthrough
• Writing the audit report
• Follow-up with corrective and preventive actions

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 Laboratories
• SOP: FDA Inspections - Preparation/Conduct/Follow-up
• SOP: Multinational GMP Inspections - Preparation/Conduct/Follow-up
• SOP: Change Control of Software and Computer Systems
• Worksheet: Auditing Analytical 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
• Most frequently asked questions and answers: Laboratory Compliance
• 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

Who should attend?

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

Cost and Ordering

Video seminar - Web download Download the video presentation from a password protected website (approx. 150 Mbytes) Order includes all reference material. Share the video and all reference material at your site	US$ 449.-
Video seminar - CD Get the CD in your mail Order includes all reference material.	US$ 449.-

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.