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 139

Inspection of Pharmaceutical Quality Control Laboratories

Understanding the New PIC/S Inspection Document

Recorded

There is a clear industry need to globally harmonize inspections of pharmaceutical companies and API manufacturers. The Pharmaceutical Inspection Co-Operation Scheme (PIC/S) is taking the lead on this. PIC/S member countries are Canada, EU, Australia, Singapore and Malaysia. Other agencies want to join, for example the US FDA has officially applied to become a member. Now the PIC/S has published an 18 page aid for GMP inspectors on how to inspect pharmaceutical quality laboratories. This is expected to harmonize inspections. The document is also extremely important for pharmaceutical companies and API manufacturers because it is ideal to prepare the industry for inspections. However, there are many questions.

Key Questions related to Inspection of pharmaceutical Quality Control Laboratories are:

• Who is the PIC/S?
• What is the relevance to agencies such as the US FDA or the EMEA?
• What is the objective and scope of the new PIC/S document?
• Why is it so important also for FDA regulated industries?
• What are the key points we should be aware of?
• What does it say about analytical instrument qualification?
• Are there any details about failure investigations, OOS or CAPA?
• Is there any difference to the US FDA inspection practices?
• Where can I get the new PIC/S document free of charge?
• How can I prepare my laboratories for upcoming FDA and international inspections?

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 all information 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:

• Introduction to the Pharmaceutical Inspection Co-Operation Scheme
• Relationship between PIC/S, the US FDA and other agencies?
• The new PIC/S inspection aid: purpose, scope, contents
  The difference between the FDA QC Laboratory guide and the PIC/S document
• Details of inspections and recommendations:
  - Quality Assurance, management review, documentation system,
  - personnel, materials, facilities, equipment,
  - sampling, sample handling, testing, failure investigations,
  - record retention
• Recommendations for FDA and international inspections

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

• SOPs:
  - FDA inspections: preparation, conduct, follow up
  - Multinational GMP Inspections: preparation, conduct, follow-up
  - Handling OOS results
  - Laboratory Failure Investigations
  - Qualification of Equipment
• Worksheets/Checklists/Examples
  - Laboratory Audits
• Reference Articles
  - Preparation and qualification of (certified) reference material and working standards
  - How to avoid FDA Warning letters
• FDA Presentations and Reports
  - Laboratory inspections
  - 2004/05 FDA Inspection report
  - Drug cGMP Requirements for Laboratory Records
• Five Warning letters and/or Inspectional observations related to Analytical Laboratories
• FDA Guidance for Industry:
  Inspection of Quality Control Laboratories
• Link to the PIC/S Inspection Aid
  Inspection of Pharmaceutical Quality Control Laboratories

Who should attend?

• QA managers and personnel
• Analysts and lab managers
• Validation specialists
• Regulatory affairs
• Human resources (HR) managers and staff
• Training departments
• Documentation department
• Consultants

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$ 349.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 349.-
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$ 249.-

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.