Why Should You Attend :

This presentation will review the forces and the barriers to main stream deployment of TeleHealth systems. We will address licensure, compliance, accessibility, quality of data, data ownership, privacy, integration, contingency plan, legal and financial issues.

Through proper planning progress towards the deployment of successful solutions for services such as: extend specialty care, improve quality care, better management of chronic diseases, cost containment, support home care, education/promotion for healthy behavior, and serving needs of remote communities can be made.

This webinar will help you understand system integration options and how to select the best fit for your organization while achieving compliance with requirements for performance by developers, integrators, users and payers.

This webinar will provide an overview and guidance to firms that are either going through or preparing to do postmarket surveillance activities. The training will cover expectations for Postmarket Surveillance Studies, the surveillance process, elements to include in a Postmarket Surveillance Study plan and expectations for different stages of Postmarket Surveillance Study Reports.

Areas Covered in the Seminar:

• Review proposed changes
• Explain the legal background and overview of statutory criteria.
• Considerations regarding pediatric population provisions.
• Understand expectations for postmarket surveillance study duration.
• Describe the postmarket surveillance process and identification of issue.
• Why an order for postmarket surveillance will be issued under section 522?
• Learn why postmarket surveillance study plans are reviewed as an original submission and its amendments until the plan is approved?
• Determine the elements to Include in a Postmarket Surveillance Study Plan.

Why Should You Attend:

Software Validation is a hot topic with the FDA because of the numerous medical device recalls related to faulty software. This webinar provides a method for performing thorough software validation using well established methods of Installation Qualification, Operational Qualification and Performance Qualification. This terms are not commonly used with software, but these processes can be successfully applied to software validation in order to reduce the likelihood of enduring a software recall.

Areas Covered in the Seminar:

• Development of software test plans.
• How to apply IQ / OQ and PQ techniques to software?
• Risk based software testing.
• How does Software Validation relate to Design Validation?
• Typical software tests.
• What is the appropriate sample size for software testing?
• Software issue tracking.
• How to address open issues when releasing software.

Why should you Attend:

FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. They are certain to impact your regulatory risk profile. How will you prepare for software quality, software validation and 21 CFR part 11 planning?

Extensive use of automated manufacturing, laboratory, QA, QC, complaints, CAPA, Adverse Events systems puts companies at risk. FDA field staff has been trained on software validation and 21 CFR Part 11 inspection and enforcement. Many companies have fallen behind in their software validation practices. Now is the time for forward planning in this crucial area. This executive planning session discusses the key elements on which to focus. The attendee should leave this strategic planning session confident in knowing how FDA will approach software validation enforcement and how to prevent needless inspections, as well as how to satisfy an FDA inspector.

Areas Covered in the seminar:

• Outline of new FDA enforcement approach.
• When will FDA issue a Warning Letter for software validation.
• What happens after a Warning Letter is issued under the new enforcement system?
• How planning can help now and in the future.
• The pivotal role of the Director of Software Quality / Software Validation.
• How your people can really help or hurt you.
• Effective software quality / validation structure.

Why Should You Attend:

This webinar will provide valuable information on the value of Risk Management in pharmaceutical, device and biotechnology operations and meeting agency expectations. It includes rationales for the use of the techniques in a variety of scenarios from plant design and construction through operations in the plant such as setting up monitoring, conducting investigations and validation planning and execution. It describes the components of the processes including how to initiate risk management, risk assessment and risk control, implementation and review of remediation and feedback linking into continuous improvement.

Areas Covered in the Seminar:

• Why Risk Management techniques are critical in both development of product and processes and also manufacturing operations and their controls?
• Where these techniques can be used in everyday operations?
• The major elements of the Risk Management process from initiation, through risk assessment and control to implementation, review and communication.
• The methodology for risk identification, quantification and prioritization.
• How Risk Management integrates and become an important element of Continuous improvement and your Quality Management System?
• What the agencies expect from you when you use the techniques?

This course will address complexities in combination products (regulatory, business and quality processes) and break them down into their simple elements. Then these elements will be rebuilt into a practical system that will enhance understanding of the requirements. This understanding of requirements will provide you with the tools you need for developing or revamping your quality system to meet this new paradigm. This will result in a smoother development and approval for your product as well as prevent any "big showstoppers" that delay or threaten your project.

Learning Objectives:

• Combination products, as its name implies, is to FDA regulated products which have different modes of action, in the diagnosis and treatment of disease. The most complex frequent is the drug & device combination.
• Provide an understanding of the differences within the various types of combination products.
• More similarities than differences exist between the GMP's for Drugs and Devices. Principles of all quality systems are the same.
• Only one quality system is required to control manufacturing, testing of combination products.
• Quality Systems for medical devices are more quality system orientated than drug GMP's but the drug GMP's are now advancing.
• The lifecycle differences between drugs and devices impact their approval and regulation.
• Staffing for combination products is much more complex than single products.
• The FDA's draft GMP guidance will be incorporated as applicable. This course is designed to better show specific similarities and differences between manufacturing single and combination products.

This course will address complexities in combination products (regulatory, business and quality processes) and break them down into their simple elements. Then these elements will be rebuilt into a practical system that will enhance understanding of the requirements. This understanding of requirements will provide you with the tools you need for developing or revamping your quality system to meet this new paradigm. This will result in a smoother development and approval for your product as well as prevent any "big showstoppers" that delay or threaten your project.

Learning Objectives:

• Combination products, as its name implies, is to FDA regulated products which have different modes of action, in the diagnosis and treatment of disease. The most complex frequent is the drug & device combination.
• Provide an understanding of the differences within the various types of combination products.
• More similarities than differences exist between the GMP's for Drugs and Devices. Principles of all quality systems are the same.
• Only one quality system is required to control manufacturing, testing of combination products.
• Quality Systems for medical devices are more quality system orientated than drug GMP's but the drug GMP's are now advancing.
• The lifecycle differences between drugs and devices impact their approval and regulation.
• Staffing for combination products is much more complex than single products.
• The FDA's draft GMP guidance will be incorporated as applicable. This course is designed to better show specific similarities and differences between manufacturing single and combination products.

Why Should You Attend:
FDA inspectors are now being trained to evaluate software validation practices. Increasing use of automated manufacturing and quality systems have increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. A third of recent warning letters included citations with respect to improper or ineffective validation. Computerized quality system tracking systems are subject to increased scrutiny during compliance and enforcement actions and hence incomplete software validations are ticking time bombs.

Once the FDA inspectors or Fedral marshalls have arrived, it's time to set up an effective software validation and software quality program - even if those were not the original citations that brought you to FDA's attention. Attend this Webinar if you have received, expect or fear an FDA-483, Warning Letter or Consent Decree. Learn steps that can be done proactively and forward plan to prevent additional software related compliance issues and how to prepare response where citations directly or indirectly include automated system.

Areas Covered in the seminar:

• Outline of FDA regulations as applied to software.
• Review of FDA software validation requirements.
• Review of FDA software expectations.
• Proactive steps to prevent additional software-related compliance and enforcement problems.
• Response steps where inspection citations directly or indirectly include automated systems.
• Forward planning.
• What to do about existing systems.
• The paradox of ongoing validation work.

This webinar on Clinically-Related 483's and Warning Letters will show how you can manage clinical site FDA inspections, handle issues, understand and respond to observations ("483") and/or Warning Letters.

By the end of this webinar, the participant will have an understanding of the context for clinical site FDA inspections and the issues that may arise. Effective handling of these issues during the inspection can reduce the risk of further regulatory action. Should observations (“483”) and/or a Warning Letter be issued, participants will have an enhanced understanding how and the timing required to respond, and how to avoid further regulatory action by the Agency.

Areas Covered in the Seminar:

• Managing FDA inspections.
• Understanding observations.
• Providing a written response.
• Responding to observations (“483”).
• Responding to a Warning Letter.
• Dealing with the ramifications.

This Webinar will highlight the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be submitted in the marketing applications to FDA.

This Webinar will address the most pressing changes and answers questions FDA has received from industry and the public. While the “draft” offers much-needed clarification on certain regulatory requirements as well as invaluable insight into FDA’s current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.

Areas Covered in the Seminar:

• Review proposed changes to the 2011 released draft guidance.
• Clarification on definition of sponsor.
• Understand FDA's clear actions that can and will be taken regarding refuse to file a marketing application.
• Learn how to submit financial disclosure information to FDA.
• Why FDA is expounding on due diligence and its significance.
• Timing of data collection and purpose.
• Understand how financial information should be disclosed to FDA.
• Update regarding financial disclosure questionnaires.
• Time period covered by regulations.
• Clarification on covered clinical study.
• Factors for FDA review of disclosed financial interests.