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How to Establish Quality Objectives that Produce Results
Diane Bove
90 Min
Product Id: 700965
The webinar provides a comprehensive and logical way to think about performance goals, metrics and the evaluation of goal progress.
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Complying with Sarbanes Oxley (SOX), Section 404
Bernice Russell Bond
90 Min
Product Id: 700944
Learn how to comply Sarbanes Oxley compliance in a cost-efficient manner. Many have questioned whether the Sarbanes-Oxley law requirements can be met in a cost-efficient manner. Absorbing the first-year lessons — and, going forward, is a challenge facing all public companies as they prepare to meet quarterly and annual reporting requirements. And further challenges will arise as new compliance issues emerge and PCAOB regulations evolve.
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Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies
Alan Hochberg
60 Min
Product Id: 700972
This presentation will give an overview of these new tools and techniques for the non-statistician/epidemiologist. It is vital that a pharmaceutical manufacturer be able to quickly assess these issues on a sound statistical basis, in a way that eliminates bias due to confounding factors as much as possible.
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Establish and Maintain an Effective Supplier Qualification Program
David Dills
60 Min
Product Id: 701036
The process is critical for device manufacturers to effectively evaluate and select suppliers and subsequently implement agreements ensuring consistent material quality and/or services provided. This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies that are preparing to establish or have established supplier/vendor management qualification programs.
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How to implement a sustainable Information Security Management System (ISMS)
George Spafford
60 Min
Product Id: 700948
This presentation will review the ISMS and architectural considerations that need to be addressed. An ISMS can help an organization effectively and efficiently manage information security related risks.
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Validating Disinfectants for Pharmaceutical and Biotech Operations
Jim Polarine
90 Min
Product Id: 701021
This Biopharmaceutical Compliance training provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Designing an effective disinfectant validation program to meet FDA and EMEA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Current 483's, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate their products against their isolates.
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The Kaizen Event and how it can help improve your Quality Program
Brad Snyder
Product Id: 700977
Kaizen Events are an extremely efficient way to quickly improve process efficiencies and effectiveness.
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What We Can Learn From Warning Letters
Anne E Maczulak
90 Min
Product Id: 700946
In this Good Laboratory Practices training on FDA warning letter learn how to avoid making the same mistakes in your study and to avoid having your company's name publically cited for inspection findings.
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Preparing for a U.S. FDA Audit
John E Lincoln
60 Min
Product Id: 700816
How to create and blend the Risk Management File findings into the company’s internal and external audit plans?
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Internal Control and Sarbanes-Oxley Section 404
Dr. Sandford Liebesman
Product Id: 700936
The core of the presentation will be an in-depth look at Section 404 and the COSO Guidance used by most organizations for compliance. We will describe the SOX legislation including the creation of the Public Corporation Accounting Oversight Board (PCAOB) and key sections of the Act.
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Investigations and Corrective/Preventive Actions
Nick Campbell
60 Min
Product Id: 701019
In this seminar, you will learn how to document unexpected situations accurately and completely. Are your investigations done haphazardly or in an inconsistent manner? Are your reports hard to understand? Is the discrepancy resolution process slowing your product release efforts unnecessarily?
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Leveraging SOX Anti-Fraud Programs to Reduce Company-Wide Risks
Peter Goldmann
60 Min
Product Id: 700938
The training supports SOX Compliance (particularly Section 30 as it pertains to anonymous hotlines), and conforms to key criteria of the revised US Federal Sentencing Guidelines. Know how to promptly and effectively REPORT incidents of fraud or suspicious conduct.
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Packaging Validation & Shipping Qualification
Richard Gaeto
60 Min
Product Id: 701006
This presentation will discuss the differences between qualifications and validations as they apply to shipping and packaging. The objective of a shipping qualification program is to verify that product can be shipped throughout the supply chain within required temperature ranges and without damage. To accomplish this companies must conduct operational and performance qualifications for their shipping configurations. The operational qualifications consisted of temperature mapping of test loads that are challenged with “worst case” temperature profiles under controlled laboratory conditions. The performance qualifications were performed concurrent with actual product shipments.
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SOX: Internal Controls for Inventory
Mike Morley
60 Min
Product Id: 700359
Effective internal controls keep track of inventory and ensure that its proper value is reflected on the financial statements This presentation will provide you with the tools you need to establish and maintain strong internal controls for Inventory that meet Sarbanes-Oxley standards
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What to Expect During an FDA Inspection, and How to Handle It
Jeff Kasoff
60 Min
Product Id: 700987
This session 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. This session will be the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
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CAPA - Root cause and risk management
Dr. Norman Howe
40 Min
Product Id: 700997
Participants will learn how to write CA reports that will be used as written & how a well maintained CAPA system will save the company time and money. This course summarizes the cGMP requirements for Corrective Action Preventive Action (CAPA) and prepares participants to complete CAPA investigations on their own.
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Principles of Sterile Manufacturing
James Harris(PhD)
60 Min
Product Id: 700991
This webinar in designed to provide the basic knowledge needed to create and operate a sterile manufacturing facility.
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Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management
Alan Hochberg
60 Min
Product Id: 700971
This presentation will give an overview of data mining systems, for the safety or regulatory professional who collaborates with data miners, and for the executive decision-maker who oversees the implementation of data mining.
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How to Apply Lean Practices to the Production Process
Thomas Gray
60 Min
Product Id: 700979
This presentation will give organization information as to how to organize itself and create a Lean Project Plan to roll-out the various lean techniques. This Webinar will provide valuable assistance to all companies looking to identify and remove waste in processes and value streams.
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Basic Requirements for Steam Sterilizer Validation per ISO 17665
Mark Dott
90 Min
Product Id: 700295
This Steam Sterilization training will review the general requirements for performing a steam sterilizer validation via the “overkill” half-cycle method as described in ISO 17665 (supersedes ISO 11134). For decades, steam sterilization (autoclaving) has been an integral part in the manufacturing and laboratory processes in the medical device, pharmaceutical, and HCT/P industries.