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Courses

  • 321 Request Info

    How to properly investigate OOS/OOT Results

    Overview The speaker will provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations. This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed. For more detail please click on this below link: http://bit.ly/2ru2Sae Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510
  • 322 Request Info

    FDA Inspection and Respond to 483 & How to Prepare them - 2017

    Overview: In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection. Why should you Attend: FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
  • 323 Request Info

    Validation Program to a Building from Top to Bottom - 2017

    Overview: Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program. Why you should attend: How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program.
  • 324 Request Info

    Best Validation Practices for Laboratory Computer Systems Regulated by FDA

    Overview We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA. Any “GxP” system (i.e., the system "touches" product during the laboratory testing or process) must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. This FDA Compliance course will describe the best practices for conducting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done. In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators. For more detail please click on this below link: http://bit.ly/2r9k1XA Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515
  • 325 Request Info

    Webinar On IQ, OQ, PQ in the Verification and Validation Process

    This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/IQ-OQ-PQ-VERIFICATION-VALIDATION-PROCESS-503654/JUNE-2017-ES-TRAININGREGISTRY
  • 326 Request Info

    FDA - Legal Writing Skills that Result in Effective Regulatory Submissions

    Overview: Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.
  • 327 Request Info

    Validating Radiation Sterilization for Medical Products

    Overview: Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
  • 328 Request Info

    Applying ICH Q3A and Q3B for Control of Impurities

    Overview: This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants. Why should you Attend: Upon completion of this course the learner should be able to: Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals Understand what specifications will conform to regulatory expectations Develop an process for reporting impurities and addressing OOS situations
  • 329 Request Info

    EU Clinical Trial regulation - 2017

    Overview: Transition between Directive 2001/20/EC and Regulation EU No 536/2014 Until the Clinical Trials Regulation EU No will become applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive 2001/20/EC. This Directive will be repealed on the day of entry into application of the Clinical Trial Regulation.
  • 330 Request Info

    Webinar On Compliance with EU Regulation for Clinical Trials

    This webinar will help ensure attendees are familiar with new regulations for running clinical trials in Europe. It will help them prepare to implement the new requirements efficiently while elaborating how clinical trials will be authorized in the future. The instructor will also detail the authority proffered to EU regulators to perform inspections of all clinical trials registered in the EU, whether they are conducted within the EU or internationally in other emerging markets.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/COMPLIANCE-EU-REGULATION-CLINICAL-TRIALS-506624/APRIL-2017-ES-TRAININGREGISTRY
  • 331 Request Info

    Webinar On Medical Device Recalls: a Preventive Strategy

    The secret to preventing medical device recalls is to implement and follow basic practices for specifications and design control, design for process reliability, production validation and design validation using accelerated life tests. This webinar is about controlling safety risk from specification writing to device retirement - control throughout the product's life cycle.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/MEDICAL-DEVICE-RECALLS-509325/APRIL-2017-ES-TRAININGREGISTRY
  • 332 Request Info

    Root Cause Analysis to Meet FDA Expectations - 2017

    Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. Why should you Attend: A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that such effective and repeatable failure investigation and root cause analysis is still not the industry norm.
  • 333 Request Info

    FDA Scrutiny of Promotion and Advertising - 2017

    Overview: DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. The days of looking at text alone for a magazine insert are long gone. Why should you Attend: That is expensive and leaves you with a cloud over your name at the FDA. That is never a good thing. You must know what you are doing with DTC advertising, not just hope you do. You will probably earn a Warning Letter by "Winging it."
  • 334 Request Info

    Good Deviation Practice - CAPA Process - 2017

    Overview: This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. Why you should attend: The attendee will learn the best practices for the deviation process and the important points from a regulatory standpoint.
  • 335 Request Info

    How to Meet FDA QSR and ISO 13485 Requirements - 2017

    Overview: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.
  • 336 Request Info

    Customs-Trade Partnership Against Terrorism (C-TPAT) Supply Chain Security and Compliance for Regulated Industries

    The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against the threat of terrorism. The program was launched in November 2001, with seven large U.S. companies as the initial participants. By the end of 2014, more than 10,000 members joined the effort. More than 4300 importers in the program account for more than half of the value of all merchandise imported into the U.S. C-TPAT certification can be attained by companies who seek to be considered low risk, enabling their cargo to be processed in an expedited manner with fewer Customs examinations. The certification involves a documented process for determining and mitigating risk throughout a company’s international supply chain. The program is voluntary, but affords those participating in it a huge advantage in terms of international trade.
  • 337 Request Info

    Effective Environmental Monitoring Program: Best Practices in Bio/Pharmaceutical Production

    Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations when sampling methods yield positive results. Whether environmental monitoring is used simply to verify a state of cleanliness within a packaging area or during the production of sterile products, the assurance for sterility or area cleanliness is dependent not only on cleaning and sterilization methods used, but also with the control of the environment in which they are produced.
  • 338 Request Info

    Pharma Analytics – I Have All These Data, Now What Do I Do?

    We know that it takes more than a large data set and computer software to effectively solve problems. As information technology increases in capability and availability the opportunity to use data to develop and improve processes becomes even greater. Particular attention is paid to the pedigree of the data: the process that generated the data, the measurement process and the data collection process including the sampling schemes used. Also essential to success is the use of subject matter knowledge to frame the problem and assess and interpret the results of the analysis.
  • 339 Request Info

    Countdown to MACRA: It's Time for Physicians to Pick Their Pace for 2017

    On October 14th CMS published the final rule that outlines its implementation of MACRA value-based payment reform starting in 2017. The new framework is called the Quality Payment Program. Going forward, clinicians and health care leaders need to be developing strategies so they can position their organizations for financial success under the new Quality Payment Program. Beginning in 2017, CMS will start rewarding clinicians for their delivery of high-quality patient care through one of two pathways: (1) payment of incentives for participation in Advanced Alternative Payment Models (Advanced APMs); or (2) application of a positive or negative adjustment pursuant to the clinician's performance under the new Merit-based Incentive Payment System (MIPS).
  • 340 Request Info

    Webinar On Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

    This course provides a background to safety reporting. There is a refresher on the definitions and reporting requirements of AE, SAE, AR and SUSARs, within a clinical trial. We look at the sources of safety information and discuss the evidence that points to the causality of an event. The change in the regulatory environment is reviewed and the role of conditional approval and PASS and PAES studies is also discussed.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/DRUG-SAFETY-PHARMACOVIGILANCE-504550/MARCH-2017-ES-TRAININGREGISTRY