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Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I
Robert J Russell
90 Min
Product Id: 701258
This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.
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New Medical Device Vigilance Guidelines
David Dills
60 Min
Product Id: 701140
This Medical device training will provide valuable assistance and guidance to all medical device companies and user facilities involved in medical device vigilance. A revised medical device guidance document on post marketing vigilance (MEDDEV 2.12-1 rev 5) was published in April 2007 by the European Commission and came into force on January 1, 2008. The 2007 update provides more guidance than the previous version, introduced in 2001, and includes new reporting terminology and concepts such as periodic summary reporting and trend reporting. In addition, the terms advisory notice, near incident, and recall have been eliminated or replaced.
The vigilance guidelines are part of a set of European medical device guidelines, known as MEDDEV documents, which are intended to promote a common approach by all involved parties on interpreting and complying with the Medical Device Directive. MEDDEV includes new reporting terminology and concepts such as “periodic summary reporting” and “trend reporting.” In addition, the timescale for reporting incidents is stricter. The terms “advisory notice,” “near incident” and “recall” have been eliminated or replaced by the new terms. As with the 2001 version, the new version refers to the incorporation of the views of the Global Harmonization Task Force (GHTF) into the European context.
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How to Prepare for, Manage, and Follow-up to an FDA Inspection
Jeff Kasoff
60 Min
Product Id: 701236
This FDA inspection training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
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Japanese PAL - Navigating the Japanese Pharmaceutical Affairs Law
Phil Smart
90 Min
Product Id: 701276
This JPAL training will emphasize on Japanese Pharmaceutical Affairs law with respect to - Classification, device approvals, clinical data, MAH (Marketing Authorization Holder),foreign manufacturer accreditation,QMS,post-market complaints & vigilance
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Maintaining a Sustainable and Compliant Design Validation System and Using FMEA for Device Manufacturers
David Dills
60 Min
Product Id: 701074
This webinar will provide valuable assistance and guidance for medical device companies to ensure they have a well defined, deployed and enforceable design validation program. Did I make the right product and can I prove it is Design Validation! Device manufacturers need to establish and maintain procedures for validating the device design. Design validation has to be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation must ensure that the company’s device or devices conform to defined user needs and intended uses and will include testing of production units under actual or simulated use conditions.
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Auditing and Compliance of Biopharmaceutical API Facilities
Frank Settineri
90 Min
Product Id: 701208
This FDA audit training will review the fundamental aspects of auditing biopharmaceutical API facilities to ensure their compliance with current regulatory guidelines.
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HACCP in a Real World Environment
John Miller
60 Min
Product Id: 701173
This HACCP training will explain the FSIS regulations and policies program requirements.
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The EU Clinical Trial Directive
Robert J Russell
90 Min
Product Id: 701259
This Clinical trial training will focus on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process.
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Risk Management as applied to Design Control
Nicolaas Besseling
60 Min
Product Id: 701212
This Risk management training will guide you through how to integrate the elements of ISO14971 (Risk management for medical devices) in your design process.
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Violation...Deviation: Whatever you call them, you need a process to manage them
Tina D Forrister
60 Min
Product Id: 701125
This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication. One of the most common inspection findings is a failure by the Investigator "…to conduct the studies or ensure they were conducted according to the investigational plans". Often, the citation isn't just that the protocol wasn't followed but that documentation surrounding management of the issue is insufficient. Therefore, Sponsors are well served by having an effective process to identify, document, and communicate departures from the investigational plan. This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication.
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Maintenance and Calibration of Equipment
Michelle Sceppa
60 Min
Product Id: 701188
This Pharmaceutical compliance training will provide instruction on how to establish and maintain a Maintenance & Calibration program for pharmaceutical instrumentation & equipment.
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Investigations of Microbial Data Deviations
Scott Sutton
90 Min
Product Id: 701239
This Biotech training will provide valuable assistance to all regulated companies that need to investigate product issues.
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What are best practices for creating a Risk Management File?
Dennis Moore
60 Min
Product Id: 701233
This Quality management training will review processes for integrating a reasonable level of risk management into the quality management system.
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Preparing for Regulatory Audits
Nick Campbell
60 Min
Product Id: 701170
In this FDA audit & Inspection training we will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution.
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Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Frank Settineri
90 Min
Product Id: 701186
This Pharmaceutical compliance training will outline actions to take to ensure the microbiological wellness of your facility and will introduce the concept of "Thinking like a Bug".
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How to Internal Audit to ISO 9001:2008
Rick Saldivar
60 Min
Product Id: 701167
This ISO 9001:2008 training will provide an understanding of the changes and requirements that Internal Auditors in ISO 9001 certified organizations will need to address to be compliant to the new ISO 9001:2008 revision.
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Virtual Manufacturing - how to manage third party contract manufacturers
Peter Calcott
60 Min
Product Id: 701228
This Pharmaceutical training will describe strategies and tactics with concrete examples of how you can set up quality systems that will assure compliance and successful operations and will satisfy the agencies.
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Combination products and convergence: an overview of clinical benefits, regulatory issues and manufacturing challenges - part 2
Michael Drues
90 Min
Product Id: 701160
This medical device training will guide you through Combination products and overview of clinical benefits, regulatory issues and manufacturing challenges. Medical products, no matter how well designed, can only do so much to address many of the clinical problems today. In order to tackle the clinical problems of the future, medical devices will be used in combination with drugs and biologics (called combination products) to treat a wide range of diseases from heart attack and stroke to Alzheimer’s and diabetes and beyond!
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How to perform effective supplier audits, and avoid FDA 483
Dennis Moore
60 Min
Product Id: 701193
This FDA audit & inspection training will provide your firm with key insights on how to perform superior supplier audits. It will help you uncover purchasing controls GMP violations.
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Lean Six Sigma and Supply Chain: Convergence
Ron Crabtree
90 Min
Product Id: 701247
In this Lean six sigma training we will explore what early adopters are doing – and what is on the horizon and a brief history of the evolution both LSS (Lean Six Sigma) in SCM (Supply Chain Management).