Medical Device Industry Trends for Computer Systems Regulated by FDA
The Webinar will focus on the importance of managing FDA oversight of computer system validation in the medical device industry by anticipating and preparing for trends. The type and extent of oversight varies with changes to the economic, political, and business environment. FDA funding, the length of government reach into the private sector, and the ability of companies to lobby the government for less regulation all play a role in terms of the dynamics at play between industry and the FDA. Medical device companies must be vigilant in understanding the factors that impact their ability to operate with oversight from FDA as it relates to computer system validation. In all cases, companies should do the right thing and have robust computer system validation programs that are well executed and documented. However, there are some extremes in oversight that occasionally crop up and may cause expectations to go above and beyond what is considered reasonable. In such cases, companies must determine how much risk to take in terms of the strength of their programs, and how well they are able to negotiate with their FDA auditors. Typically, a medical device company will develop a relationship with the FDA office that sends auditors to oversee computer system validation programs in their organization. Depending on upcoming trends, medical device companies may want to work harder to further strengthen these relationships and build greater trust with FDA to ensure that even as oversight becomes more overbearing, it will not cause the company to waste resources trying to meet expectations that may be unrealistic. A good example of a recent trend is the focus on risk management in developing, executing and documenting a validation program and validation plans for specific systems at medical device companies. FDA has fewer resources to conduct audits and oversight of computer system validation, hence medical device companies have been expected to identify the risk associated with each computer system that “touches” a medical device product (through manufacturing, testing, distribution, etc.), and take the appropriate measures to mitigate that risk. The trend has been for FDA to ask questions relevant to risk and ascertain fairly early during an audit what lengths the medical device company has gone to in order to prove they have thoroughly validated their systems accordingly.
Carolyn Troiano
Duration : 90 Mins | Level : Intermediate | Start Date: April 24, 2017
Process Validation for Drugs and Biologics
This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management. Participants will learn how to develop rigorous protocols and reports, as well as create monitoring programs to ensure that defined critical parameters remain in control. The course will also review validation requirements for systems that generate electronic signatures and records as most new processes have this capability.
Joy L McElroy
Duration : 90 Mins | Level : Intermediate | Start Date: April 27 2017
Customs Considerations in Free Trade Agreements, Including TPP and NAFTA (and/or Advanced Country of Origin)
The cornerstone of the global trading platform is the classification of products under the WTO’s Harmonized Commodity Description and Coding System, generally known as the Harmonized System (“HS”), implemented in the United States under the Harmonized Tariff System of the U.S. (“HTSUS”). This global system defines among and between all member nations a codified methodology for defining what a product is as it crosses international borders. In most countries, the HS serves for both import and export classifications. By contrast, in the United States, there is an additional, simplified classification system foe US Exports called the Schedule B. In the first half of this session, we will discuss these classification systems, what the legal rules are for applying them to your globally trade goods, and how best to meet the legal standard of exercising reasonable care when assigning classifications to your imported and exported merchandise.
Ms.Waltuck Barnett
Duration : 120 Mins | Level : Intermediate | Start Date: March 21, 2017
Ransomware and Business Email Compromise
Bank and Credit Union Retail Centers are often faced with handling consumers disputing ACH debits on their account. This session focuses on the most common disputes, and provides Retail staff with a basic understanding of what is required to maintain compliance.
Rayleen M. Pirnie
Duration : 90 Mins | Level : Basic | Start Date: March 24, 2017
The Fallacious Fecal Coliform
Thermotolerant coliform is a generic term for “coliforms” capable of multiplying and producing gas at temperatures ca. 44 C. They are not definitively of fecal origin. The species E. coli is the only definitive Thermotolerant coliform associated with fecal contamination...
Michael Brodsky
Duration : 60 Mins | Level : Intermediate | Start Date: March 27, 2017
Finance for Project Managers
In this webinar, you will learn the language of finance; how to read balance sheets and income statements; how to analyze retained earnings and cash flow statements; financial fundamentals, revenue recognition, percent of complete, work-in-process, cash flow impact, and more. The information-packed webinar has been developed following the accelerated learning model of teaching adults. Interactive exercises, relevant examples, and attendee participation reinforce learning keep the webinar interesting and fun.
William R. Kay
Duration : 90 Mins | Level : Intermediate | Start Date: March 27, 2017