21 CFR Part 11: Gap Analysis, Remediation & Adding Value to Validation

In 1991 the pharmaceutical industry met with FDA to determine how best to accommodate paperless record systems under CGMP regulations. The final result, published in 1997, was 21 Code of Federal Regulations Part 11. It provides industry with quantitative information for electronic records and signatures that can be used to add value to the validation of automated systems. Part 11 regulations can be used to accomplish three tasks: create new requirement specifications that comply with Part 11 regulations, assess existing automated systems for Part 11 compliance, and remediate Part 11 compliance gaps in existing automated systems.

In this audio conference, attendees learn how they can quickly and easily assess and remediate their current systems for Part 11 compliance, and how to add value by incorporating Part 11 into the validation effort.

21 CFR Part 11: Gap Analysis, Remediation & Adding Value to Validation is being presented by Jeffrey Gassman, President & Founder, of Validation Plus, Inc. and airs on Thursday, July 16, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

On-Site Clinics: Next Big Opportunity or Next Big Threat for Pharma?

More than 1200 of the largest companies in the US have already established more than 1800 on-site clinics to serve the needs of their employees and their families. These clinics have the potential to reshape pharmaceutical sales for years to come. On-site clinics are poised for double-digit growth, and by some estimates could account for over 10% of all pharmaceutical prescriptions written for those under 65 by the year 2015. They will cover both branded and OTC products, and many will have their own pharmacies for immediate dispensing. Most are likely to be linked into sophisticated health management programs, which will be designed to act as high-value compliance programs paid for by the employers. But is this an opportunity or a threat to industry?

Certainly there is the possibility that many of the companies will launch their own formularies, limiting the types of remedies covered. In this audio conference our speakers discuss this new frontier, including who is leading the charge with on-site clinics and what it means for the pharmaceutical industry. As an added bonus, attendees will receive a copy of Fuld’s On-Site Clinics white paper.

On-Site Clinics: Next Big Opportunity or Next Big Threat for Pharma? is being presented by Leonard Fuld & Mike Ratcliffe, Founder & President and Director of Research, with Fuld & Company, Inc. and airs on Thursday, June 11, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Overcoming Challenges in Clinical Cold Chain Transport

Global transport of temperature-sensitive investigational drugs and clinical materials presents a tremendous challenge for pharmaceutical and biotech companies. There are many factors to consider in order to ensure that product integrity remains intact. Successful delivery of investigational drugs from origin to patient is becoming more complicated, especially with increased scrutiny placed on in-transit temperature control and monitoring. As cold chain shipment excursions face increased scrutiny from regulators around the world, it is more important than ever to get it right the first time.

In this audio conference, the speakers review the areas that need to be considered by the clinical development community in order to maximize the performance of their cold chain R&D investments.

Overcoming Challenges in Clinical Cold Chain Transport is being presented by Anthony Leone & Les Sparrow, International Customer Service Manager, Quality Assurance & Technical Support Manager, with World Courier, Inc. and airs on Tuesday, May 12, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Risk-Based Software Validation for Medical Devices

It isn't glamorous, and sometimes it isn't even considered a core competency necessary for our business. But in the medical device industry, software validation often consumes a huge portion of the budget for new software products, even when that wasn't the original intent. Unfortunately, software testing methods haven't kept pace with innovations on the product development side. Just as we look to new and improved ways to complete software development, medical device companies also need to be looking for new and improved ways to validate that software.

In this audio conference we examine the various approaches to software validation, and discuss how and why to consider risk as part of the validation process. The presentation also looks at ANSI/AAMI/IEC 62304:2006 Medical Device Software - Software Lifecycle Processes, and how it uses risk to drive software verification and validation.

Risk-Based Software Validation for Medical Devices is being presented by Bob Barrett, Systems Engineering Lead, with Intertech Engineering Associates, Inc. and airs on Wednesday, April 22nd, 2009. To register, or for more details please visit our site www.fxconferences.com

Improving the Readability of Your Patient Information

Life sciences companies go to great lengths to provide patients and users with all the information they need to use products safely and effectively. But how do you ensure those patients understand what you are telling them? According to the Institute of Medicine, nearly half of the adult population in the United States may lack the skills needed to function within the healthcare system. The FDA says patient materials should be written at a 6th to 8th grade reading level, while recently revised European Commission guidelines call for "well designed and clearly worded" package inserts.

In this presentation, the speaker provides attendees with the tools to overcome some of the challenges encountered when communicating written health care information. The presentation includes a brief overview of health literacy in the U.S., and discusses how plain language, organization and format can all be used to create PPIs, medication guides, marketing collateral and patient education materials that conform to current regulatory guidelines.

Improving the Readability of Your Patient Information is being presented by Jennifer Hicks, President, with WordsWork Consulting, Inc. and airs on Thursday, March 26th, 2009. For more details, please visit our site at www.fxconferences.com

The Pre-IND Program: 12 Steps to a Successful IND Filing

The Pre-IND phase of drug development is the foundation upon which all subsequent IND research depends, in order to obtain FDA market approval (NDA) after completion of required Phase 1-3 trials. Therefore, it is essential to give proper forethought and attention to these first, all-important steps. This audio conference looks at the 12 essential steps to complete during the Pre-IND phase of development leading to the filing of an original IND with the goal of obtaining FDA approval for initial Phase 1 clinical trials.

Our speaker, veteran industry expert Dr. Larry Hofmann, will give expert guidance on the optimum background and make-up of your pre-IND development team. He will also discuss strategic planning for and preparation of the FDA meeting information package -- provided to the FDA reviewing division 30 days prior to the pre-IND meeting -- which must include available pharmacology and toxicology summaries, as well as a summary of CMC data on the IND clinical formulation to support the proposed Phase 1 and Phase 2a study protocols.

The Pre-IND Program: 12 Steps to a Successful IND Filing is being presented by Dr. Larry Hofmann, President, with LMH Associates, Inc. and airs on Tuesday, March 31th, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1) credit toward a participant's RAC recertification upon completion.

Biologic vs. Non-biologic: Current FDA Thinking on IVDs

In the United States, in vitro diagnostic products are classified and reviewed under two separate FDA Centers, depending on whether the product is intended to be used to diagnose a condition, predict if a particular treatment will be effective or monitor the effect of a treatment, or if it is intended to be used in the testing of transfusable blood or cellular products.

In this audio conference we highlight the differences in the two product review processes between the Centers and provide insight into their expectations regarding information required in submissions and following product approval. Recent Guidance Documents issued by FDA are discussed.

Biologic vs. Non-biologic: Current FDA Thinking on IVDs was presented by Ann Quinlan-Smith & Pamela J. Vaughan, President & Senior Principal Consultant, with Alquest, Inc. and aired on 2008-02-28. For more details about purchasing a download, please visit our site www.fxconferences.com