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
On-line Audio Seminar 111
Writing Effective SOPs for the Healthcare
"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
- 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
- How frequently should SOPs be reviewed and updated?
- Are there example SOPs or templates we can use as a starting
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
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,
- 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
- 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
- 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
Who should attend?
- QA managers and personnel
- Site and operations managers
- IT managers and staff
- Validation specialists
- Regulatory affairs
- Training departments
- Documentation department
How to order
Pick one of the options in the table that fits your needs.
Replaced by the more recent seminar
Writing Effective SOPs For
Content, format, approval, training
About audio seminars
Online audio seminars are presented over the
phone. During the live presentation attendees can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- 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
||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,