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Courses

  • 281 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
  • 282 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
  • 283 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
  • 284 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
  • 285 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
  • 286 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
  • 287 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
  • 288 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
  • 289 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.
  • 290 Request Info

    Webinar on The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectation

    This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective clinical studies in the U.S. and EU.
  • 291 Request Info

    Online Webinar on Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under one Umbrella

    In this webinar, the presenter with 1st hand proficiency in setting up and speaking the quality language of medical device and the pharma world will provide unique tips for those companies that are making the transition from medical device to pharmaceuticals and vice versa.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/DEVICE-QUALITY-MGMT-SYSTEM-501262/FEB-2016-ES-TRAININGREGISTRY
  • 292 Request Info

    Online Webinar on USP [467] Residual Solvents: Overview of General Principles and New Additions

    This training will provide an overview of General Chapter USP <467> requirements for testing of residual solvents and limits, along with providing updates on the new content added to provide greater flexibility in testing compliance.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/USP-FDA-ANALYTICAL-CHEMISTRY-501223/FEB-2016-ES-TRAININGREGISTRY
  • 293 Request Info

    Online Webinar on Clinical Evaluation and Risk Management

    Medical devices sold in the European Union fall under the Medical Device Directive (MDD). The webinar includes a discussion of clinical evaluation, including the recommendations from MEDDEV 2.7-1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies. The webinar also covers MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up. 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/Clinical-Evaluation-and-Risk-Management-501229/FEB-2016-ES-TRAININGREGISTRY
  • 294 Request Info

    Webinar on HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

    This webinar details and explains the various US and international regulatory requirements for various cleanroom classifications. Environmental control of pharmaceutical cleanroom is essential to the manufacture of a quality product. 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/CLEANROOM-MONITORING-SYSTEM-501231/FEB-2016-ES-TRAININGREGISTRY
  • 295 Request Info

    Conference about Validation Master Planning and Regulatory Expectations

    Overview: Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic. This presentation will cover the importance of master planning. The FDA and other regulatory bodies expect these to be among the Quality System documentation. How best should it be implemented and maintained? What are the types and how many should there be?
  • 296 Request Info

    Global Personal Care Market & Regulatory Overview

    Cosmetic products are ubiquitous in our daily life. Consumers are bombarded with newer and more attractive product offerings constantly. The cosmetic and toiletry industry continues to enjoy relatively good standing despite global recession. While traditional stronghold such as Western Europe, Japan, and the US appear to have been near their market saturation, the emerging markets such as Latin America and Asia have been roaring ahead with powerful growth. The former usually have established fairly sophisticated laws and regulations, while the latter tends to present more challenge as individual countries go through legislative evolution to integrate better into the global regulatory framework. In general, to place a personal care product successfully in today's market requires more than superior formulation and attractive packaging. Despite years of international effort at harmonization, the cosmetic regulation has yet to arrive at a totally harmonized state, globally . . .
  • 297 Request Info

    Workshop on Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

    If you use pharmaceutical Contract Manufacturing Organizations (CMOs), your company has ultimate responsibility and accountability for product quality, safety, and efficacy; as well as cGMP compliance. Therefore, issues identified at your CMO may result in FDA 483s and/or Warning Letters issued to your company. In other words, you cannot just outsource operations and forget about it. You must select the proper CMOs and actively manage the operations performed on your behalf. At the end of the day, your organization’s ability to provide proper quality oversight of CMOs is the key to assuring product safety and your company’s compliance profile. Price:$1,399.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/workshop/Effective-Quality-Oversight-CMOs-800006/JAN-2016-ES-TRAININGREGISTRY
  • 298 Request Info

    Webinar on Orphan Medicinal Product Designation in the EU

    Overview: The European Medicines Agency plays a central role in the development and authorization of medicines for rare diseases. These medicines are termed ‘orphan medicines’ in the medical world. It is estimated that today in the EU, 5-8000 distinct rare diseases affect 6-8% of the population - about 30 million people. Rare diseases are defined as life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in EU. This is equivalent to around 250,000 people or less for each disease. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/Orphan-Medicinal-Product-Designation-in-the-EU
  • 299 Request Info

    Webinar on Quality Oversight of Pharmaceutical Contract Manufacturing Organizations

    If you use pharmaceutical Contract Manufacturing Organizations (CMOs), your company has ultimate responsibility and accountability for product quality, safety, and efficacy; as well as cGMP compliance. Furthermore, FDA has stated that organizations using CMOs will be held accountable for CMO compliance to cGMPs, as well as CMO adherence to the contracting firm’s regulatory commitments. Therefore, issues identified at your CMO may result in FDA 483s and/or Warning Letters issued to your company. In other words, you cannot just outsource operations and forget about it. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CONTRACT-MANUFACTURING-ORGANIZATIONS-501182/JAN-2016-ES-TRAININGREGISTRY
  • 300 Request Info

    Webinar on Preparation is the Best Medicine: Getting Ready for OSHA's New Strict, Expanded Enforcement against the Healthcare Industry

    The Occupational Safety and Health Administration has announced a new and stricter enforcement policy for the healthcare industry. The new federal enforcement policy, OSHA's recent new Inspection Guidance for Inpatient Healthcare Settings, which identifies five major hazard areas that OSHA inspectors will now examine as part of every visit & Inspection to a hospital, nursing home and residential care facility. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/OSHA-COMPLIANCE-501200/JAN-2016-ES-TRAININGREGISTRY