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.

What Needs To Be in a Product Submission: An FDA Reviewer's Perspective

Presented by Dr. Joshua Sharlin
Tuesday, March 9, 2010 -- 1:00pm to 2:30pm EST (GMT -5)

Don't miss this popular and practical teleconference on understanding how FDA reviewers think and work...and using that information to improve your submission content and reduce approval anxiety.

FDA Submissions. You've finally completed your submission to the FDA and are ready to send it in. What are the FDA reviewers going to think? Are you sending in a submission that will delay, or worse, deny your product’s approval?

FOI Services is pleased to announce a teleconference presented by a former FDA reviewer who has trained thousands of people from hundreds of companies on how to be more effective with the FDA. This popular teleconference is designed to give you the essentials for preparing an outstanding submission. This session describes general principles of how to improve submissions and applies to drugs, devices and biologics. The discussion will also summarize the results of an FDA-sponsored study that identified the distinguishing characteristics of NDAs and BLAs approved with no review cycles.

On Tuesday, March 9 at 1:00pm EST, join FOI Services and Dr. Joshua Sharlin for a 90-minute presentation that will help you see your submission from FDA's vantage point.

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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 -5) to register.

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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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.