CimQuest Presentations at InterPhex to Emphasize Risk Management and Quality Improvement in Pharmaceutical Manufacturing.Health/Medical Writers/High-Tech Writers Interphex 2004 EXTON, Penn.--(BUSINESS WIRE)--Jan. 27, 2004 FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. auditors this year will focus on the high-risk manufacturing systems most likely to affect human health and safety, making 2004 the year of risk management and quality improvement in pharmaceutical manufacturing. Best-in-class companies will use the regulatory process to cut waste and improve profits, not just achieve compliance. CimQuest's Hi-Q benchmarking and process improvement tool points the way. CimQuest, Inc., the regulatory compliance consulting firm Noun 1. consulting firm - a firm of experts providing professional advice to an organization for a fee consulting company business firm, firm, house - the members of a business organization that owns or operates one or more establishments; "he worked for a , said it would focus on risk management and quality improvement in pharmaceutical manufacturing - and on how to improve pharmaceutical sales and marketing practices - in three presentations during the Interphex Pharma IT Summit, at the Jacob Javits Center, New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. , March 16-18, 2004. "The FDA is making every effort to become more efficient and effective in the way it interprets and enforces regulations that govern the drug industry," says CimQuest CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Frank Kurtz Col. Frank Allen Kurtz (September 9, 1911 – October 31, 1996) is known as an Olympic diver, as an aviator, the United States Army Air Force's most decorated pilot of World War II being awarded the Croix de Guerre, 3 Distinguished Flying Crosses, 3 Silver Stars, 3 Air Medals, . "Commissioner Mark McClellan Mark Barr McClellan (born June 26, 1963) was sworn in as Administrator for the Centers for Medicare and Medicaid Services in the United States Department of Health and Human Services on March 25, 2004. wants to focus the agency's limited resources on the most important areas affecting human health and safety. Beginning this year, specially-trained FDA inspectors will focus on the potential for quality breakdowns in high-risk manufacturing systems." Commissioner McClellan has won high marks from industry for his pragmatic approach to enforcement. A physician and economist, McClellan wants to enforce regulations in ways that encourage companies to make manufacturing process improvements that lead to safer, less expensive drugs and more productive plants. At the same time, FDA is training inspectors who will specialize in pharmaceutical manufacturing, making them expert in spotting problems they might have missed before. "As always, FDA's bottom-line goal is to prevent unsafe drugs from reaching market," says Kurtz. "Companies must address the agency's renewed emphasis on risk assessment and process improvement if they want to avoid enforcement actions. However, we at CimQuest advise manufacturers to move beyond the 'comply-or-be-punished' paradigm by using risk management and quality improvement to cut waste and re-work, enhance productivity and increase profits. FDA is now oriented to this approach. And that's the whole purpose behind our Hi-Q methodology." CimQuest's Hi-Q program is designed for pharmaceutical manufacturers who want to achieve operational excellence and the benefits it brings: not just regulatory compliance, but reduced waste and re-work, increased productivity and higher profits. Hi-Q describes five distinct levels or "quality states" in pharmaceutical manufacturing, ranging from Hi-Q Iron - the lowest level of quality - up to Platinum, denoting the highest level of operational excellence. CimQuest's Hi-Q risk management and quality improvement methodology can be used to diagnose manufacturing problems and develop solutions for companies as they move step by step toward operational excellence. CimQuest Presentations at InterPhex CimQuest experts will make three presentations at InterPhex. Each presentation will provide a risk-based approach to complying with FDA regulations. Thanks to CimQuest's Beyond Compliance approach to risk management and quality improvement, attendees will also learn new ways to cut waste and re-work, improve productivity and boost profits. CimQuest's presentations include: "GXP GXP Geospatial Exploitation Products GXP Galaxy Police (anime) GXP Grid Exit Point (utilities, electricity) GxP Good X Practice Requirements for the IT Environment," Tuesday, March 16, 1:00 p.m., by Kevin Martin, CimQuest's Regional Vice President, New Business Development. Although software may have the ability to be compliant with FDA regulations, the environment under which it is used must also be capable of supporting it as well. Martin will discuss the GXP requirements (i.e. predicate In programming, a statement that evaluates an expression and provides a true or false answer based on the condition of the data. rules and guidance documents) and describe a process model for implementing an appropriate IT infrastructure based on GAMP for supporting FDA regulated systems. Martin's presentation is based on an actual case study of a major pharmaceutical company. Martin has 25 years of experience in pharmaceutical computer systems compliance. He has directed the analysis, design and validation of computer-based manufacturing and laboratory systems to ensure FDA 21 CFR CFR See: Cost and Freight Part 11, GxP, 510(k), CAP, CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a '88, and/or NCCLS NCCLS National Committee for Clinical Laboratory Standards compliance. "A Capability Maturity Approach to Achieving Compliance Excellence," Tuesday, March 16, 3:30 p.m., by., by Kevin Martin, CimQuest's Regional Vice President, New Business Development. This workshop provides a structured approach to assessing a company's (or department within a company) level of compliance and helping them to achieve operational and compliance excellence. By applying a capability maturity assessment model that is tightly coupled with a risk-based analysis, key compliance elements are identified. This model includes building blocks and uses a stepwise stepwise incremental; additional information is added at each step. stepwise multiple regression used when a large number of possible explanatory variables are available and there is difficulty interpreting the partial regression approach for any company or department to elevate themselves to the next higher level of compliance. Upon achieving the highest maturity level, the company or department will realize operational excellence and be at the highest level of compliance. "Protecting Pharmaceutical Sales & Marketing Practices In An Era of Heightened Enforcement," Thursday, March 18, 3:15 p.m., by Gale Robinson, CimQuest's Subject Matter Expert for PDMA PDMA Product Development & Management Association PDMA Prescription Drug Marketing Act PDMA Philadelphia Direct Marketing Association PDMA Plastic Deformation Magnetic Assembly PDMA Polarisation Division Multiple Access . (Prescription Drug Marketing ACT
Robinson will look at the enforcement issues outlined within the Prescription Drug Marketing Act (PDMA), which to date has cost industry more than $2.5 billion in settlements and has affected the market value of several pharmaceutical companies found in breach of the Act. The workshop will introduce ways to mitigate the risk of violations, how to prioritize risk in order to develop a specific project, and how to drive activities to a state of compliance and control. Robinson has more than three decades of experience in regulated environments, including the US military, Nuclear Regulatory Commission Nuclear Regulatory Commission (NRC), an independent U.S. government commission, created by the Energy Reorganization Act of 1974 and charged with licensing and regulating civilian use of nuclear energy to protect the public and the environment. , and the US Food and Drug Administration. About CimQuest CimQuest, Inc. is recognized as a leader and innovator in computer systems validation support and quality services to the regulated industries. CimQuest provides intensive, global support to the pharmaceutical, biotechnology and medical device industries with expertise in Corrective and Preventive Actions (CAPA CAPA California Alternate Performance Assessment CAPA Captaris, Inc (stock symbol) CAPA Confederation of Asian and Pacific Accountants CAPA Creative and Performing Arts (school) ), 21 CFR Part 11 Assessments and Remediation, and FDA cGxP regulations. CimQuest's Global Compliance Alliance(TM) provides expert FDA compliance and validation services to pharmaceutical, biopharmaceutical and medical device corporations worldwide. |
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