Understanding Risk Management and Compliance, What is different after Monday, July 29, 2013

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Specifically, the IFU for Right Angle Electrodes from your contract manufacturer includes a voltage warning stating that any voltage exceeding Vp could lead to tissue damage. However, the IFU included in the finished device does not have the voltage warning. However, your firm design validation failed to consider the conditions similar to those that are expected to be experienced in the user environment, the actual conditions of use, or how the lack of explicit instructions could lead to device malfunction or injury to the patient.

Your firm is currently awaiting confirmation from b 4 and plans to complete labeling updates by February 15, Your firm should perform a risk assessment to determine whether correction or removal is necessary for the affected products. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR For example:. Your firm failed to identify actions needed to correct and prevent recurrence of nonconforming products. However, your firm did not initiate a corrective action to reduce re-occurrence of either issue. The procedure requires an escalation of a corrective action when a supplier issues b 4 CAPA reports over a b 4 period.

Your firm had multiple suppliers which met this criteria, but failed to issue CAPAs. Your firm did not document justifications for not opening a CAPA. CAPA was initiated on September 27, , to investigate a trend in complaints related to an increased return of suction tubes. The corrective action was to change the method b 4.

Understanding Risk Management and Compliance What Is Different After Monday November 16 2015

The corrective action was completed and dated February 16, Your firm reopened the CAPA in the first quarter of and a memo to file, dated February 9, , indicated that b 4 method was changed to b 4 method. However, no validation of the b 4 method was included in the file. Failure to establish and maintain procedures for acceptance activities, which include inspections, tests, or other verification activities, as required by 21 CFR Specifically, the following deficiencies are noted:.

Your firm lacked acceptance criteria for the final device acceptance activities. However, specific details related to what to check and what tools to use were not defined. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR Your firm plans to retrospectively review Class II products to address the above deficiency. Your firm should confirm that the DHF has been updated to include necessary design plans.

For example, during the sampling of b 4 complaint records, none of the complaint records which were not reported as Medical Device Reporting MDRs include documentation of the MDR evaluation nor did they document the justification for not reporting. Your firm has not performed a review of the complaint files to determine how many complaints are missing required data elements.

Your firm has not made an attempt to gather missing required data elements.

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Your firm has not updated its complaint handling procedures to specify if MDR evaluations will be recorded. Failure to review and evaluate all complaints to determine whether an investigation is necessary and when no investigation is made, maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR For example, your firm failed to document the rationale for not investigating a complaint and the individual making the determination in the complaint record.

Your firm has not performed a review of the complaint files to determine how many complaints are missing the required data elements. Your firm has not documented a decision to not open an investigation on deficient complaints. Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR Failure to maintain records of changes to documents to include a description of the change, identification of the affected documents, the signature of the approving individual s , the approval date, and when the change becomes effective, as required by 21 CFR For example, your firm claimed to have recently revised its CAPA procedure, SOP, and at the time the CAPA data was compiled, there was no requirement to open a corrective action report based on b 4.

Failure to establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, as required by 21 CFR For example, at the time of the inspection, your firm was unable to explain why a sample size of b 4 units was selected for design validation of b 4 dated August 2, Your firm also stated that the sample size of b 4 units was not based on any valid statistical rationale.

He is also a Certified Internal Auditor. She is an adjunct professor of taxation at the A. Freeman School of Business, Tulane University. She provides consulting services for individuals, corporations and other entities in areas of taxation, financial planning, estate planning and business succession planning.

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Her litigation experience includes testimony and forensic accounting services in accounting, financial, economic and business issues. She is a frequent lecturer on tax, estate planning, litigation and forensic accounting topics before national, state and local forums.

Cindy Sobieski Partner Deloitte. Cindy currently works internationally identifying, evaluating, managing, and mitigating professional services risks for the worldwide network of Deloitte Member Firms.


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As a Global Risk Management Partner, she consults and develops positions and policies on practice protection, enterprise and risk management and provides oversight and support of risk priorities and initiatives. Cindy is a CPA and has been a member of the accounting profession for over 30 years. She began her career as a staff auditor with Deloitte and was assigned increasing responsibilities progressing to partnership.

Her experiences include being a Lead Client Service Partner providing professional services to large, multinational clients and leading engagement teams conducting audits, due-diligence and regulatory filings. In addition to direct client service, Cindy has also held leadership and management roles. In this role, she participated on FASB working groups and projects. Additionally, Cindy designed and delivered the Technical Excellence case studies learning programs for audit partners and managers used in the Deloitte-sponsored Trueblood Seminar and Case Study Series - pedagogical faculty tool for accounting professors.

Besides working in public accounting; Cindy is an Accounting Advisory Board Member for Post University where she is on the adjunct faculty and teaches accounting and auditing courses. She is a demonstrated leader with a history of developing new competencies and proficiencies. Cindy is a role model and mentor helping and motivating others to realize their professional aspirations. Tim Louwers Jackson E. Ramsey Centennial Chair in Business. Prior to beginning his academic career, he worked in public accounting with KPMG specializing in financial, governmental, and information systems auditing.

Some of his works have been reprinted in Russian and Chinese. Professor Louwers is a respected lecturer on auditing, fraud, and technology-related issues. Joseph R. Included in these services is testifying and preparing for trial as a qualified expert on numerous cases. He presents and is developing continuing education and outreach courses for various organizations. Petrucelli has been teaching as an adjunct Professor at the College of Staten Island since He has taught accounting and taxation related courses as well as served as an academic advisor. He also has served on the Edison Chamber of Commerce as a Trustee.

Currently, Mr. Petrucelli is a member of the Edison Finance Committee in New Jersey where he assists council members with the municipal budget. He has worked with many nonprofits and other organizations. Various Mayors of New Jersey have appointed Mr. Petrucelli as a special financial adviser. Petrucelli is an avid guitar player, father of two and has been happily married for 26 years. Prior to his CFO position, Peters worked for a regional CPA firm where he focused on advising clients with improving the business operations through forensic accounting, internal auditing, litigation support, data analysis, strategic planning, and business valuation.

He received his Ph.

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He currently serves as editor of the Journal of Labor Research. Professor Newman also serves as a private economic and statistics consultant. His consulting activities include serving as an economics consultant to several major law firms and corporations on issues related to earnings and compensation policies, job market discrimination cases, and other related employment issues. In addition, for several years Professor Newman served as a consultant to major pharmaceutical companies dealing with federal and state prescription drug policies. Barnes earned his Ph. Barnes has publications on the impact of the labor force on health insurance coverage.

In addition, Dr. Barnes has published numerous reports on health insurance, labor market conditions, and employment projections through the LSU Division of Economic Development. Skip to main content. Ourso College of Business.