Teleconferences

View a list of available Audio CDs of previous teleconferences

Spotlight on SOPs

Standard Operating Procedures play a vital role in your FDA compliance activities. Learn more about them with CDs of these popular teleconferences, presented by Dr. Joshua Sharlin.

FDA's New Guidance & Enforcement: Company Websites, Email & Online Advertising

Presented by Joshua Sharlin, Arnie Friede and Carlen Lea Lesser
Thursday, July 9, 2009; 1:00 p.m. – 2:30 p.m. EDT (GMT -4)

FDA is rapidly changing the rules about communication on the Internet:

Over a dozen Untitled Letters, 45 misbranded drugs, and a new guidance document...all in three months.

On March 26, 2009 FDA sent Untitled Letters to 14 companies identifying Internet activities that violated the Federal Food Drug & Cosmetic Act -- creating 45 misbranded products. Soon after, on May 27, 2009, FDA released a 27-page draft guidance "Presenting Risk Information in Prescription Drug and Medical Device Promotion" to explain how FDA now evaluates prescription drug/biologic and device promotional pieces for adequate presentation of risk information.

How will these new expectations change your company's website and web-based advertising? And with this FDA-initiative progressing so quickly, what should you do now to comply in this strict and fast-changing regulatory environment?

On Thursday, July 9, beginning at 1:00 p.m. EDT, join FOI Services and FDA-regulatory specialist Dr. Joshua Sharlin, attorney Mr. Arnie Friede and internet marketing strategist Ms. Carlen Lea Lesser for a 90-minute teleconference discussing these developments and how they will affect your Internet presence.

Take advantage of the advice of this experienced panel of experts to review your website, online advertising and email outreach…before FDA examines it for you.

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SOPs for SAS Programming: Tools for 21 CFR Part 11 Compliance

Presented by Joshua Sharlin - Thursday, July 16, 2009
1:00 p.m. to 2:30 p.m. EDT (GMT -4)

Standard Operating Procedures for SAS Programming. You know FDA requires them, they're irreplaceable in maintaining compliance, and they’re excellent training tools. And rather than design yours from scratch, now you can take advantage of a set of SOPs designed and explained by an expert.

Want some help getting started or advice for improving your existing SOPs? On Thursday, July 16, join FOI Services and Dr. Joshua Sharlin for this popular ninety-minute teleconference, last offered in the summer of 2008.

In this presentation, Dr. Sharlin will discuss a set of fifteen model SOPs you need for FDA compliance in your SAS Programming operations. The SOPs will be made available as part of the course notes as well as in MS Word format to allow you to easily modify the models for your own environment. Model SOPs will cover the following areas of SAS programming:

Initial SAS Installation
Maintaining SAS software
Requirements Specifications
High Level Design
Program Design
Database Specifications
Directory Structure
Coding Conventions
Log Review
Debugging
Change Control
Testing
Create SAS Transport Files
Risk Assessment

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A Tool Kit for Quality Systems Management Review: Prove Compliance to the FDA, EMEA & Health Canada

Presented by John Avellanet, Cerulean Associates LLC
Tuesday, July 21, 2009; 1:00 p.m. – 2:30 p.m. EDT (GMT-4)

Over the past 18 months, FDA has issued 63 Warning Letters citing companies for “failure of management to implement and maintain an effective quality system…” or “periodic management reviews have not ensured that the quality systems satisfies the requirements….”

With the FDA now enforcing ICH guidelines for biologics, drugs, and combination device firms – including the Q10 requirement that companies hold regular Quality Systems Management Reviews involving senior management – being able to prove compliance has only become more complex and more uncertain. EMEA and Health Canada officials have long seen a company’s Quality Systems Management Review as a leading indicator of the depth of their inspections. When setting inspection priorities, FDA officials also take into consideration a company’s pattern of proving effective compliance.

The penalties of non-compliance are not insubstantial. Quality Systems Management Reviews are turning up in corporate integrity agreements such as those with Bristol Myers-Squibb, and consent decrees, such as that with KV Pharmaceutical, requiring regular reviews of the quality system and proof of senior management involvement.

Inspectors from the FDA, EMEA and Health Canada are trained to request summaries and copies of your reviews. When the inspector asks, do you know what to give him, what not to…and why? This information isn’t covered in guidance documents, rather, each firm develops its own techniques and hopes they’re adequate. But there is more you can do.

On Tuesday, July 21, 2009 beginning at 1:00 p.m. EDT, join FOI Services and John Avellanet of Cerulean Associates at a 90-minute teleconference to cover the regulatory requirements for holding a Quality System Management Review; what the inspector is looking for in your records; and walking you through how to prepare for, conduct, and then closeout a meaningful Quality Systems Management Review, including what documents you must have in order to prove your quality system and regulatory compliance program is effective. You’ll also receive proven checklists and templates you can easily adapt for your environment.

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30-Minute Update! ClinicalTrials.gov & FDA Requirements for a Certification of Compliance

Presented by Dr. Joshua Sharlin
Wednesday, July 22, 2009, 1:00 p.m. to 1:30 p.m. EDT (GMT -4)

Early in 2009, FDA released the final version of a guidance that has recommendations on the types of submissions that must have a Certification of Compliance (FDA form 3674). Beginning in December 2007, FDA began requiring companies (drugs, biologics and devices) to register study protocols and enter trial results into the ClinicalTrials.gov web site. FDA can fine companies up to $10,000 per day for non-compliance. To confirm required information has been entered into ClinicalTrials.gov, FDA requires submissions to include the Certification of Compliance.

On Wednesday, July 22, beginning at 1 pm EDT, join FOI Services and Sharlin Consulting for a quick, half-hour teleconference designed to make sure you're current with this fast-changing regulatory issue. And if you have time, stay for an extra ten minutes and participate in a question and answer session!

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I Hate My PI - or How to Select Good Principal Investigators & Work with Them

Presented by Michael Hamrell, PhD
Thursday, July 23, 2009; 1:00 – 2:30 pm EDT

One of the first steps in setting up a clinical trial is selecting clinical investigators who will actually conduct the study. Often problems and issues come up with the study and the principal investigator (PI) during the study that can cause a substantial friction and discomfort between you and the investigator and his/her staff. Communications will break down, and your study can become out of control. These issues can delay or even terminate a study, putting your product application in jeopardy.

Selecting a really good principal investigator and understanding potential problems and issues can often help reduce or eliminate many of these issues before they become a problem. What steps should you be taking before, during, and after a clinical trial?

Listen to an internationally recognized expert on GCP Compliance and a former FDAer on how to select good investigators and foster a good working relationship. On Thursday, July 23 beginning at 1:00 p.m. EDT, join FOI Services and Dr. Michael Hamrell for a 90-minute teleconference offering advice in avoiding unnecessarily expensive, time-consuming, and potentially non-compliant clinical trials.