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Courses

  • 1 Request Info

    Webinar On Post-marketing Adverse Event Reporting for Non-prescription Human Drug Products Marketed Without an Approved Application

    This webinar is designed to review the guidance documents related to adverse event reporting for OTC drugs. A review of the applicable requirements for adverse events reporting will assist an organization to adhere to the law as well as meet reporting timeframes.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/POST-MARKETING-EVENT-REPORTING-501352/MAY-2016-ES-TRAININGREGISTRY
  • 2 Request Info

    Webinar On Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products

    This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.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/ADVERSE-EVENT-REPORTING-501405/MAY-2016-ES-TRAININGREGISTRY
  • 3 Request Info

    Webinar On Medicare Penalties and Incentives- 2016 Updates for Medical Practices

    Medicare has included both Penalties and incentives to encourage participation and correct report for multiple programs. This webinar will review the programs that are currently targeted for these actions.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/MEDICARE-COMPLIANCE-501448/MAY-2016-ES-TRAININGREGISTRY
  • 4 Request Info

    Webinar On Final revised Draft to ISO 14644 Parts 1 and 2 changes Classification and Monitoring Methods: Are you prepared?

    This webinar will discuss ISO 14644-1:2015 standard practices and their applicability to the environmental monitoring of aseptic manufacturing facilities.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/ISO-14644-1-2015-501442/MAY-2016-ES-TRAININGREGISTRY
  • 5 Request Info

    Webinar On Efficient and Effective Batch Record Reviews to Improve your Process Capabilities

    Upon completion of this session, attendees will learn the fundamentals for reviewing batch records in a pharmaceutical environment. They will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and they will learn how to react to discrepancies found in these records.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/BATCH-RECORD-REVIEW-501451/MAY-2016-ES-TRAININGREGISTRY
  • 6 Request Info

    Webinar On GMP Complaint Systems and Product Recalls

    This webinar will discuss the requirements for a system for complaint and recalls in an FDA compliant company.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/GMP-COMPLAINT-SYSTEM-501413/MAY-2016-ES-TRAININGREGISTRY
  • 7 Request Info

    Webinar on How to Prepare for ICH E6 (R2) GCP Revisions

    This training program will discuss the revisions to ICH E6 R2 GCP. How these changes may impact your clinical trials in terms of cost and complexity. We will also review plans for risk management, human subject protection, and data integrity. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/HOW-TO-PREPARE-ICH-E6-R2-GCP-REVISIONS-501456/MAY-2016-ES-TRAININGREGISTRY
  • 8 Request Info

    Webinar On Validation of a HPLC/UPLC Methodology

    Instrumental liquid chromatography (HPLC method development/ UPLC method development) commonly used in the pharmaceutical, environmental, and other areas for analyses needs to comply with either Good Laboratory Practices or ISO 17025 training. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/VALIDATING-HPLC-METHODOLOGY-501397/MAY-2016-ES-TRAININGREGISTRY
  • 9 Request Info

    Webinar on System Suitability Testing for FDA and USP Compliance

    System suitability testing (SST) is required by USP and FDA to check and ensure on-going performance of analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and other agencies. Related chapters have been updated by USP and EP and they also answer the question as to how much a method can be changed without the need for revalidation. Also, the USP chapter <1058> makes a statement that SST can substitute an instrument's performance qualification, but not further guidelines are given. This webinar will give a good understanding of FDA and USP requirements for system suitability testing. 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/SYSTEM-SUITABILITY-TESTING-FDA-USP-501436/MAY-2016-ES-TRAININGREGISTRY
  • 10 Request Info

    Webinar on USP <800> - Guidelines for Safe Handling of Pharmaceuticals

    The course will cover the current regulations and importance of preparing and handing sterile and hazardous pharmaceuticals. It will also review the proposed regulation concerning all aspects of handling hazardous drugs and is appropriate for medical, nursing and pharmacy workers. Understanding these regulations will allow users to future-proof their facility and employ best work practices when performing both non-sterile and sterile HD handling. 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/USP800-GUIDELINES-501386/APRIL-2016-ES-TRAININGREGISTRY
  • 11 Request Info

    Webinar on 6 Most Common Problems in FDA Software Validation and Verification, Computer System Validation : Step-by-Step

    This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered. 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/LATIN-AMERICAN-TRADE-501303/APRIL-2016-ES-TRAININGREGISTRY
  • 12 Request Info

    Webinar on The Importance of the Investigator Responsibilities and Legal Commitments in Drug and Device Clinical Research in Achieving a Clean Audit

    This webinar will familiarize the Principal Investigator and other investigators in a friendly Peer to peer manor of the current regulations that govern our activities and why not knowing the rules is an open invitation to be embarrassed when there is an FDA audit. 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/CLEAN-AUDIT-501350/APRIL-2016-ES-TRAININGREGISTRY
  • 13 Request Info

    Webinar on Elemental Impurities: The New Requirements

    This webinar is designed to provide a comprehensive overview of impurities which must be controlled in pharmaceutical products. It will also provide detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/ELEMENTAL-IMPURITIES-501374/APRIL-2016-ES-TRAININGREGISTRY
  • 14 Request Info

    Webinar on Packaging and Labeling for Commercial and Clinical Products

    This training program will discuss optimizing your packaging design for commercial and clinical products and translating a protocol into effective packaging design. Attendees will learn how to implement an effective artwork change management system. Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be 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/PACKAGING-LABELING-COMMERCIAL-PRODUCTS-501363/APRIL-2016-ES-TRAININGREGISTRY
  • 15 Request Info

    Webinar on CMS 2016 New Pharmacy and Medication Hospital CoP Standards

    Did you know that CMS issued a 45 page memo announcing in advance many changes to the hospital CoP pharmacy standards in 2016? This includes changes to ten tag numbers or sections and these are now final. This also include changes regarding compounding of medication and beyond use date (BUD) and to bring them into alignment with acceptable standards of practice. Language was included to allow the surveyor to cite the hospitals at either the standard or condition level. This webinar will discuss in depth about the CMS new pharmacy and Medication Hospital CoP standards. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/HOSPITAL-CoP-STANDARDS-501290/APRIL-2016-ES-TRAININGREGISTRY
  • 16 Request Info

    Webinar on Guidance on new EU Clinical Trial Regulation (EU-CTR)

    On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation"). Especially the procedure for assessment and approval of multinational clinical trial authorization applications will change. A single authorization procedure for clinical trials will be introduced that will be performed electronically via a new EU portal.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/EU-CLINICAL-TRIAL-REGULATION-501339/MARCH-2016-ES-TRAININGREGISTRY
  • 17 Request Info

    Webinar on Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach

    Since there is so much different interpretation of regulatory statements and because different agencies have different philosophies, those who do not have a deep comprehension of the sterilization design relative to the microbiological impact (why many sterilizers have been improperly designed), the webinar will discuss the definition of "Sterile" and how to get there by describing different sterilization methods, various approaches to be used for the validation of a sterilization process using moist heat as template that can be used for other sterilization methods and what requirements for routine monitoring and control of sterilization are required.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/STERILIZATION-PROCESS-501284/MARCH-2016-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar on Best Practices for Communication between IND Sponsors and FDA During Drug Development process

    Effective communication with FDA is critical in successfully bringing any therapeutic product to market. However, communication includes much more than the written regulatory submission. Effective communication in all its forms must be concise, carefully considered, and reviewed to achieve the desired outcome.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-DEVELOPMENT-PROCESS-501342/MARCH-2016-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar on Analytical Procedures and Method Validation for Drugs and Biologics

    It is required of regulatory agencies that Analytical Procedures be provided with NDAs, ANDAs, BLAs and Supplements. A thorough understanding of the current thinking of what regulatory agencies consider to be appropriate as supporting documentation will help with the approval process and prevent unnecessary delays.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/ANALYTICAL-PROCEDURES-METHOD-VALIDATION-501322/MARCH-2016-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar on Validating Radiation Sterilization for Medical Products

    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.