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 111

Writing Effective SOPs for the Healthcare Industry

Recorded

"No adequate procedures" or "procedures not followed" are amongst the most frequently cited deviations in FDA Warning Letters and 483's. About all FDA regulated companies have SOP's but why is it that they are not accepted and used by their employees and by the FDA? There seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.

Key Questions are:

• What do FDA and other regulations state about procedures?
• When do we need formal SOPs vs. working procedures or test scripts etc?
• Who can and who should should write and approve SOPs?
• How detailed should SOPs be?
• We are generating SOPs with computers, how should we distribute them: as paper print-outs or PDF files?
• We have SOPs but most of our staff does not use or follow them, how can we motivate them?
• How to organize an SOP?
• What should go onto the cover page, what should be in the header and footer?
• How to make sure that our staff is always using the most current version?
• How frequently should SOPs be reviewed and updated?
• Are there example SOPs or templates we can use as a starting point?

How does the this 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:

• FDA and EU requirements
• Examples of FDA Warning Letters and 483's and recommendations how to avoid them
• Responsibilities: who writes, who reviews, who approves, distributes and maintains SOPs
• Procedure for generation of the SOP from initiation to distribution, maintenance and updates
• Contents of SOPs: Level of details, cover page, footer, header
• How to organize an SOP
• How to train users on SOPs
• How to motivate managers and staff to use and follow SOPs
• Special considerations and recommendations for electronic documentation system
• Frequency of reviews

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

• Five Example SOPs:
  - Generation and Maintenance of SOPs
  - Training for GxP and Part 11 Compliance
  - Qualification of Equipment
  - FDA Inspections – Preparation, Conduct, Follow up
• Gap analysis/checklist:
  - SOPs for the Healthcare Industry
• Warning letters and Inspectional observations related to SOPs.
• FDA and EU regulations with references to SOPs

Additional benefit: Receive six case studies

Case studies include typical planned and unplanned changes from production control, laboratory controls and documentation. They include planned and unplanned changes of specifications, hardware, firmware, operating software, application software and MS security patches.

Who should attend?

• QA managers and personnel
• Site and operations managers
• IT managers and staff
• Validation specialists
• Regulatory affairs
• 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.