Home  |  Success Stories  |  Advising  |  Newsletter  |  Speaking  |  Articles  |  Seminars  |  Reports  |  Services  |  About Us  |  Contact Us    

Home Client Results SmarterCompliance Program Compliance Newsletter Speaking & Workshops Articles & Case Studies Seminars & Resource Kits Industry Reports & Links Specialized Consulting Services About Cerulean Contact Info

 

Seminar & Resource Kit Details

FDA GMP Enforcement Trends and Priority Inspection Areas

CD includes the one-hour presentation and Q&A session with attendees plus all the individual slides, reference material and customizable training certificate.  Speaker: John Avellanet. Event ID: 664612

 

Summary

Tougher investigations and enforcement penalties are on the rise, particularly with the new powers to levy fines granted to the FDA by the FDAAA 2007.  Pharma, biotech and device executives are being held accountable even if they did not participate in or know about the wrong-doing.

This seminar will help you spot the red flags in your organization before the inspector comes knocking.

Based on discussions with FDA officials, plus the suggestions of clients and members of the SmarterCompliance Toolkit program, this recorded seminar is full of the critical information you need to stay out of the crosshairs of the FDA for the next 2-3 years.

Is your company on the list for inspection this year?

You will learn:

• The three new business-critical areas the FDA is turning its eye upon

• What your recall policies must address - and measure - at all costs

• What the inspector will examine when it comes to your CAPA and MDRs

• Current FDA targets and priorities

• Red flags the inspector looks for based on your type of company

• Recent enforcement actions and FDA expectations

• What the FDA wants to see when it comes to your quality systems plan priorities

• And much more

On the CD:

• Customizable training certificate

• Printable speaker's slides

• Synchronized audio recording of the presentation and Q&A session

• Industry report:  FDA Enforcement Trends and Recommendations 2008-2009

• And more

This information-packed recorded seminar will help see your firm with the inspector's eyes with advice straight from the FDA.  You will never again worry about the knock on the door.

Your purchase also includes a complimentary six-month trial to the SmarterCompliance newsletter of FDA intelligence, practical quality systems advice, and regulatory compliance analysis ($144 value).

About the Presenter

John Avellanet is a well-known leader in lean compliance and quality systems management.  He is a frequent and sought-after speaker for corporate management workshops, trade association conferences, business schools, and forums such as FDAnews, FOI Services, PharmaQbD, the Management Roundtable, and Expert Briefings.  He publishes the monthly executive newsletter, SmarterCompliance™, has written more than 30 articles syndicated in biopharmaceutical and device journals world-wide, and is a co-author of the book, Best Practices in Biotechnology Business Development.  Many of his clients and SmarterCompliance™ subscribers view him as their senior  compliance and quality advisor.

 

To Order

For your convenience, we accept payment through PayPal's secure site using any major credit card.  After purchase through the secure site, if you are not automatically redirected, click on the Return to Cerulean link.  If you would prefer to pay with purchase order or invoice and check, please use our quick order form or contact us.

CD or Download

CD (default) - $325.00 Download - $325.00

 Note:  We use PayPal's encrypted site to process credit card payments - you do not need a PayPal account.

 

Additional Details

The purchase price for the recorded seminar is $325 USD (shipping is free).  We accept MasterCard, Visa, Discover, and American Express through PayPal for online payment.

For details on how PayPal secure credit card payment works, see below.

If you have any questions, or would prefer to pay with check or purchase order, contact us.

 

Secure Payment

We use PayPal's encrypted site to process credit card payments.  You do not need a PayPal account to use your credit card - PayPal simply serves as the "middle man" between your credit card and our bank.

PayPal® is the world's first and largest encrypted online payment service using credit cards.  PayPal enables individuals and businesses to send and receive payments through encryption over the internet.  No account is required.

Three-step process:

• Click on the "Buy Now" button.  This will take you to the encrypted, secure PayPal site.

• Input your shipping and billing information.  You do not need a PayPal account.

• After payment is verified and you've see your receipt, you should be automatically redirected to Cerulean - if not, click on the button "Return to Cerulean Associates LLC".

PayPal will also send a copy of your receipt to your e-mail address.

For more details and to watch a video demo, visit the PayPal website.