The Press Release Resource

A deadline is coming up on April 2, 2012 in the lawsuit filed for investors of Columbia Laboratories Inc. (NASDAQ:CBRX) over certain statements made by Columbia Laboratories Inc. that at the time they were made were materially false and misleading. Investors with a substantial investment in Columbia Laboratories Inc. (NASDAQ:CBRX) shares between December 6, 2010 …

The Shareholders Foundation announces that an investor in shares of Columbia Laboratories Inc. (NASDAQ:CBRX) filed a lawsuit in the U.S. District Court, District of New Jersey against Columbia Laboratories Inc. over alleged Violations of Federal Securities Laws in connection with certain statements concerning Columbia Laboratories’ progesterone vaginal gel. Investors who purchased shares of Columbia Laboratories …

The Shareholders Foundation announces that investor in NASDAQ:CBRX shares filed a lawsuit against Columbia Laboratories Inc. over alleged Violations of Federal Securities Laws in connection with certain statements concerning Columbia Laboratories’ progesterone vaginal gel. Investors who purchased shares of Columbia Laboratories Inc. (NASDAQ: CBRX) have certain options and there are strict and short deadlines running …

  At a German cheese producer, glass-free pH sensors from METTLER TOLEDO are being successfully used to control cultivation of starter culture in fermentation reactors. The sensor fully meets strict process safety requirements.   German Dairy Producer Our customer is a German specialist producer of cheeses such as camembert and brie. Within their highly modern …

Overview: This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan. This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities. We will discuss both laboratory instruments …

Overview: This webinar will examine the existing and proposed requirements for the FDA’s DHF – including its derivative documents, the DMR and DHR. It will consider the MDD’s TF/DD requirements, and evaluate the documents’ differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and …

Overview: Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s and expanded as an international expectation for the industry with the publication of ICH Q2 in the mid 1990s. Both USP <1225> and …

Overview: FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. Although the guidance appears to remove the need to follow GMPs …

Overview: If you handle any electronic patient information, don’t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but also in …

Overview: In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10,000. We will …

Overview: In this session, attendees will learn what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule – there are substantial similarities, and being prepared for one helps you prepare for the other, as well as for other requirements, such as breach notification. We will discuss how …

Overview: This session will present the background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process. The risk analysis process will be presented within the context of the overall risk prioritization and risk mitigation process, using an example. The Information Security …

Overview: The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing …

Overview: This webinar will provide an overview of process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its application …

Overview: This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for …

Overview: This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems. Case …

Overview: This webinar will provide valuable assistance and guidance to device companies in involved in labeling changes. FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via …

Overview: This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U.S: “The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance …

Overview: This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered.  Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and …

Overview: This webinar will cover several recommendations to improve the hospital’s Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: DEA …

Overview: HIPAA Business Associate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs. The session will provide attendees the following tools, benefits, and solutions: The audience will learn how business associates are now handled under the law and the proposed regulations and what has changed from the old rules. The …

Overview: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed …

Overview: This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA’s concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates …