• All New Electronic Submissions Must Conform to eCDT format - For Pharmaceutical Industry

    18 April, 2017 Lane Hirning

    For well over a decade, there has been an initiative by the International Conference on Harmonization (ICH) to standardize formats for new drug applications in the U.S., Europe, and Japan (where the majority of new medicines are developed).  In the past, the format and organization of submissions varied by country, which made it difficult and time-consuming for a U.S. drug company, e.g., to submit an application for drug approval in Japan or the United Kingdom, and vice versa. A com

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  • New FDA Guidance to Balance Risks and Benefits of Drugs

    18 April, 2017 MasterControl

    FDA to Provide Emerging Drug Safety Information

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  • FD&C Amendments at Work in the Pharmaceutical Industry - Are They Working for Your Company?

    18 April, 2017 Marci Crane

    The FD&C (Food, Drug and Cosmetic) Act, initially passed in 1938, has greatly influenced, and continues to influence, the ebb and flow of the pharmaceutical industry. The FDA also plays a big part in that influence since it is common for the FDA to interpret the Act for executive purposes.

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  • At the Heart of Clinical Research: The Protocol

    18 April, 2017 Rebecca Daniels Kush

    The protocol is core to every clinical research study; it is the plan. The protocol is used in designing the study, selecting investigative sites, developing the data collection tools, describing the study procedures and the analysis plan. Institutional Review Boards (IRBs) or Ethics Committees use the protocol as the basis for approving whether a study can be initiated. A well-constructed protocol can ensure common understanding of the study objectives and procedures to be implemented, there

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  • From Poison Squad to Industry Regulator: A Historical Perspective of the FDA

    18 April, 2017 Robyn Barnes

    It hasn't always been this way. If you take a historical perspective, the FDA has been in the game for nearly 200 years.

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  • Investigating Clinical Trial Investigators Means More Headache for Drug Sponsors

    18 April, 2017 Michael McCaughan

    One leading indicator of a more enforcement-minded approach at the food & drug administration may be a crackdown on clinical trial investigators suspected of fraud. One thing is already clear: sponsors who rely on investigators who trigger suspicions will pay a price in the form of an even tougher time getting the drug through FDA.

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  • Writing and Maintaining SOPs: Drudgery or Delight?

    18 April, 2017 Katy McMullin, Senior Professional Services Consultant at MasterControl

    "SOPs! We don't need no stinking SOPs!"

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  • FDA Compliance Software

    18 April, 2017 MasterControl

    Companies competing within the rigorous FDA regulated environments know how important attaining and sustaining compliance is to yearly success which can be easily achieved through MasterControl's FDA compliance software. MasterControl Inc. is a leading provider of FDA compliance software, helping hundreds of life science companies around the world realizes their EU regulatory and FDA compliance goals. Our quality management system meets all FDA 21 CFR Part 11 regulations.

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  • Writing and Maintaining SOPs - Sep 09 - B&B Article

    18 April, 2017 MasterControl

    "SOPs! We don't need no stinking SOPs!"

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  • AUG Writing and Maintaining SOPs: Drudgery or Delight?

    18 April, 2017 Katy McMullin, Senior Professional Services Consultant at MasterControl

    "SOPs! We don't need no stinking SOPs!"

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  • How They Did It: Pfizer's Transition from 50 Document Management Systems to One

    18 April, 2017 Craig Barrila, World Wide Head of Information and Records Management, Pfizer, and Beth Boucher, World Wide Head of Global Network Services, Pfizer

    Like many other pharmaceutical companies, Pfizer has been through numerous mergers, acquisitions and divestitures. Two notable ones were the acquisition of Warner Lambert in 2001 and Pharmacia in 2003. The mergers, acquisitions and silo work practices fractured Pfizer's highly regulated and controlled documentation over many sites and systems. This included our GxP Standard Operating Procedures, product labeling, submissions management and trial master file systems.

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  • GCP Compliance Strategies for 2009 - Medical Device Industry

    18 April, 2017 Carl Anderson, Regulatory Affairs and Quality Assurance Consultant, Field of FDA Health Product Approvals including Medical Devices, Drugs and Biologics

    The FDA press release dated April 30, 2008 should have caught the eye of every regulatory affairs and quality assurance professional responsible for compliance to the FDA. "FDA Embarks on Major Hiring Initiative for its Public Health Mission" the press release blared. "Agency will fill more than 1,300 positions within the next several months," it continued. That is more than triple the number of positions the agency filled in fiscal years 2005-20071.

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  • Beyond the Basics - Building Business Value through an Effective Compliance Program

    18 April, 2017 Peter Claude, Pharmaceuticals and Life Sciences Partner, and Jean Sands, Pharmaceuticals and Life Sciences Manager, PricewaterhouseCoopers LLP

    Through the recent overhaul of the AdvaMed Code of Ethics, medical device companies gained the opportunity to use the renewed emphasis on ethics to revamp their approach to compliance. Most companies quickly integrated the updated Code provisions into their compliance policies and trained their employees to follow explicit guidelines about appropriate and inappropriate interactions and arrangements with healthcare professionals. Now they stand ready to take the next steps to build global complia

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  • Failure Investigation: Treating the Root Cause, Not the Symptoms

    18 April, 2017 Karl Vahey, Director of Compliance, International RA/QA, Covidien

    Why should medical device manufacturers perform failure investigations? One reason is that it is a regulatory requirement. The Code of Federal Regulations (21 CFR 820) in areas such as Non-Conforming Product, Corrective and Preventive Action and Complaint Files describes the requirements for failure investigations. Performing effective failure investigations is also good business practice which can lead to reduction in scrap and rework, process improvements and the elimination of recurring issue

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  • Human Factors: Why it is Critical in Designing Medical Devices

    18 April, 2017 David Jensen, Staff Writer, MasterControl

    “Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.” 

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  • Analytical Method Validation: What is Expected?

    17 April, 2017 Michele Piepoli

    The Food and Drug Administration (FDA), International Organization for Standardization (ISO), European and other regulatory authorities have requirements and expectations regarding the performance and documentation of an analytical method validation.

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  • What is the FDA's Third-Party Inspection Program and pMAP?

    17 April, 2017 Gregor Dzialas, Third-Party Inspection Program Manager, TUV Rheinland

    Many medical device manufacturers do not realize they can save time, money and resources while satisfying inspection requirements by the FDA and other conformity assessment providers. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the FDA introduced the Inspection by Accredited Persons Program or Third-Party Inspection Program. Under this program, eligible Class II and III medical device manufacturers can turn to an FDA-accredited third party to perform U.S. regulato

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  • CAPA: Key Stumbling Block for Device Firms

    17 April, 2017 MasterControl

    GE OEC Medical Systems recently signed a consent decree with the FDA because of CGMP deficiencies, including failure to establish and maintain adequate corrective and preventive action procedures. The news that a company this size has a broken CAPA system is shocking. But at the same time, it is not altogether unexpected if you consider inspection trends for this industry.

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  • FDA Postponing Annual Registration of Medical Device Establishments

    17 April, 2017 MasterControl

    The FDA announced in June that it is postponing the annual registration of registered medical device companies for 2008.

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