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.

SOPs for Implementing a Risk-Based Approach to FDA Part 11 Compliance

Presented by Dr. Joshua Sharlin
Thursday, March 11, 2010 -- 1:00pm to 2:30pm EST (GMT -5)

Meeting Part 11 regulatory requirements can be expensive and time consuming. With today’s limited resources, how do you justify and document your selective compliance efforts?

The solution -- performing a risk assessment -- has strong support from FDA.

On Thursday, March 11, join FOI Services and Dr. Joshua Sharlin beginning at 1:00pm EST for a 90-minute teleconference to hear about how to use risk assessment to differentiate between systems that require detailed Part 11 compliance documentation from those that don’t. The presentation will also explain the differences in risk assessment between writing programs, installing software and changing hardware. In addition to detailed course notes, you’ll get the easy-to-edit SOP templates and checklists you need to document and justify your compliance strategy.

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Online registration has closed. Please call us at 1-800-654-1147 (+1-301-975-9400 outside the U.S. and Canada) by 12:45 p.m. EST (GMT -4) to register.

FDA's International Programs

Presented by Mark Elengold
Tuesday, March 16, 2010; 1:00pm to 2:30pm EDT (GMT -4)

Over the past 5 years, FDA has been working to end what many considered an isolationist attitude. As a result, the agency has established many new international programs, enhanced harmonization efforts and opened permanent offices around the world.

Many of these initiatives, including submission harmonization, supplier controls and other efforts impact virtually all FDA-regulated industries, not just firms maintaining an international presence. Even the information FDA and foreign regulators have about you and your suppliers doesn’t necessarily stay within their walls – more than 26 countries and international organizations from Australia to Vietnam have agreements to share information with FDA.

Don’t jeopardize your next inspection or submission by overlooking an important new initiative -- be sure you know which of FDA's International Programs may apply to you. On Tuesday, March 16 beginning at 1:00pm EDT, join FOI Services and Mark Elengold for a 90-minute look at FDA activities outside the U.S., including the expansion of foreign inspections and the effects expected from the new international offices, obligations resulting from the harmonization of requirements, information sharing with counterpart foreign officials and participation in groups such as PIC/s.

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

Presented by Joshua Sharlin; Thursday, March 18, 2010
1:00pm - 2:30pm EDT (GMT -4)

Standard Operating Procedures for SAS Programming. FDA requires them, they're irreplaceable in maintaining compliance, and also exceptional training tools.

Don’t design yours from scratch. Take advantage of a set of 15 SOPs designed and explained by an expert.

If you need help getting started or want to hear about opportunities for improving existing SOPs, take advantage of tried-and-tested techniques and templates. On Thursday, March 18 beginning at 1:00pm EDT, join FOI Services and Dr. Joshua Sharlin for a popular ninety-minute teleconference that is pragmatic, time-saving, and an outstanding way to learn more about FDA’s Part 11 as it relates to SAS.

In this practical presentation, Dr. Sharlin will discuss a set of fifteen model SOPs you need for compliance in your SAS programming operations. The SOPs will be annotated and discussed in extensive course notes, and will also be offered as templates in Word format to allow you to easily modify them to fit your own environment.

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What's Next for FDA's cGMPs? Issues in Current Good Manufacturing Practices

Presented by Mark Elengold, President, FDA Strategies LLC
Tuesday, March 23, 2010; 1:00pm - 2:30pm EDT (GMT -4)

The word Current is, by definition, an integral part of the Good Manufacturing Practice regulations. With cGMPs, FDA provides a method to assure the safety and effectiveness of medical products – and that means incorporating techniques demanded by new technologies and research results. Relying on yesterday’s practices and failing to follow currentFDA initiatives can lead to problems in facilities that were previously found to be in substantial compliance.

Through the cGMPs, FDA controls variables of production and provides a framework of quality and recordkeeping procedures. These procedures can touch on unexpected topics. For example, on September 23, 2009, FDA proposed rules for the application of GMPs to combination products, including some you might not consider combinations. Every manufacturer should consider the potentially unanticipated impact of these new regulations.

In these changing times of Congressional examination of FDA, decreasing public confidence in the agency, increased efforts in international harmonization, and more focused resources, staying current with FDA’s and other regulators' views on GMP requirements is vital to keeping you in compliance -- and out of the news.

Keep the CNN trucks out of your parking lot. On Tuesday, March 23, beginning at 1:00pm, join FOI Services, Inc. and Mark Elengold of FDA Strategies LLC for a 90-minute teleconference to examine the current state of GMP enforcement, how your peers are (or aren’t) dealing with these issues, and what FDA may be eyeing next for the GMP regulations.

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

Presented by Mark Elengold
Thursday, April 1, 2010; 1:00 - 2:30pm EDT (GMT -4)

One of the first (and most important) steps in initiating a clinical trial is selecting the clinical investigators who will actually be conducting the study. Your selections can have a profound effect on the trial outcome: you can insure a smooth and trouble-free trial, find that you'll be spending far too many resources at a particular site, or even be left with unusable, indefensible data for your eventual submission.

Problems can arise during any clinical trial, and you want to avoid a principal investigator (PI) who will create or magnify issues by overlooking or ignoring instructions or causing substantial friction and discomfort. Communications will break down, and the study may even become out of control. These issues can endanger patients, delay or even terminate a study and put your product application in jeopardy.

Selecting an effective and responsible principal investigator and awareness of potential problems will help reduce or eliminate many of these issues before they threaten the integrity of your data. What are the steps you should be taking before, during, and after a clinical trial?

Get some practical advice on selecting and working with your principal investigators from an experienced, internationally-recognized former FDAer and expert on Good Clinical Practice compliance. You’ll learn about what to look for in a PI and hear about fostering a productive and comfortable working relationship.

On Thursday, April 1 beginning at 1:00 p.m. EDT, join FOI Services and Dr. Michael Hamrell for a 90-minute teleconference for pragmatic hints to help you avoid unnecessarily expensive, time-consuming, and potentially non-compliant clinical trials which can result from choosing the wrong PI.