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 225

Six Steps to Successful FDA GMP Inspections

With Tool Kits for Preparation, Conduct and Follow-up

Recorded

An FDA inspection can be a business disaster that costs your company money, time and reputation, or it can be an opportunity to make a long lasting good impression at the FDA and to improve your quality systems.

Single and multiple 483 Inspectional Observations and Warning Letters can be a disaster for a company. Bad reputation for the company and employees, delay of new product approvals, import alters, products recalls, multi-million $ fees, seizures and consent degrees can be the consequence if not followed up correctly in time. However, 483's and warning letters can be avoided.

Knowing FDA regulations and guidelines help but are not enough. Knowing what FDA inspectors are looking at and knowing enforcement practices and trends are equally important. And when it happened, damage can be minimized by effective and timely response.

Key Questions related to FDA Inspections are:

• What is FDA's system inspection process?
• Which GMP systems are always inspected?
• What are inspectors looking at within the systems?
• What are most common deviations?
• How to prepare our staff for an inspection?
• How to treat an inspector?
• What to do if I don't agree with the inspector's observations?
• What documents should be available and what can/should we give or not give to the inspector?
• How can I avoid 483's and Warning Letters: during the inspection, in the exit meeting, afterwards?
• How to follow up on 483s and warning letters

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:

• Six steps steps to successfully surviving FDA inspections
• Inspection process for API and drug manufacturing
• Current inspection and enforcement practices
• Writing an SOP for inspections
• Preparing your staff for an FDA inspection
• Conducting internal audits in preparation for FDA inspections
• Required documents and the right format
• How to treat the inspector
• Understand what the inspector is most interested to look at and why
• What to say and what not say during inspections
• The right response to observations during  inspections
• Responding to 483's and warning letters
• Current most common inspection findings

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

• FDA Inspection Survival Guide: 80 page document everybody should be aware of
• SOPs:
  - FDA inspections - preparation, conduct, follow up
  - Internal audits - The idea preparation for FDA inspections
• Gap analysis/check lists
  - FDA Inspections: preparation, conduct, follow-up
  - Good Manufacturing practices
• More than 200 examples of FDA GMP 483s/Warning Letters/EIRs
  With keyword search and instant download
• FDA Presentations - Leaning from the inspectors
  - Insight on FDA Inspections and Recommendations
  - The Inspection is Over – What Happens Next? Possible FDA Enforcement Actions
  - Writing An Effective 483 Response
  - FDA API Inspections
  - FDA cGMP Inspections
  - FDA Update: Data Integrity and Fraud – Another Looming Crisis?
  - Laboratory GMPs and Inspectional Issues: an FDA Perspective
• FDA Guides
  - Foreign inspection guide
  - Inspection of pharmaceutical QC labs
  - Drug manufacturing inspections guide
  - FDA Inspections of Clinical Investigators
• And more....

Who should attend?

• QA managers and personnel
• Analysts and lab managers
• Validation specialists
• Regulatory affairs
• Training department
• Documentation department
• Consultants

Date, time and duration

Order at any time, replay 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.-
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.