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Courses

  • 1 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.
  • 2 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
  • 3 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
  • 4 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
  • 5 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
  • 6 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?
  • 7 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 . . .
  • 8 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
  • 9 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
  • 10 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
  • 11 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
  • 12 Request Info

    Webinar on Drug Product Submission (NDS) Preparation in CTD and eCTD Format

    This webinar describes how to organize new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) based on the FDA expectations to approve the submission. 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-PRODUCT-SUBMISSION-501237/JAN-2016-ES-TRAININGREGISTRY
  • 13 Request Info

    Webinar on Combination Products-The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

    The FDA has ensured that clear FDA requirements were in place for drugs, devices, biological produces as well as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). However, there were no regulations in place to clarify and explain the application of cGMP requirements for combination products. The FDA is seeking to change that with the issuance of a guidance document that describes and explains the final rule on cGMP requirements for combination products. 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/COMBINATION-PRODUCTS-501219/JAN-2016-ES-TRAININGREGISTRY
  • 14 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. So, is your facility ready for OSHA's close exam? 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
  • 15 Request Info

    Webinar on The Basics of Professional Regulatory Law: Licensure and Certification, with an Emphasis on Health Professions

    Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? Price : $139.00 Contact Info: MentorHealth Phone No: 1-800-385-1607 FaX: 302-288-6884 support@mentorhealth.com Event Link: http://bit.ly/The-Basics-of-Professional-Regulatory-Law http://www.mentorhealth.com/
  • 16 Request Info

    3 Hrs. Virtual Seminar: Understanding and Controlling Biofilm - Preventing Water System Microbial Problems

    3 Hrs. Virtual Seminar: Understanding and Controlling Biofilm - Preventing Water System Microbial Problems Location: Attend Live Webinar Dates: 23-Nov-2015: 1:00 PM EST Duration: 180 Min Speaker:T C Soli T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant. Prior to full time consulting, he had 25 years of diverse "Big Pharma" operating company experience. Course Outline: Microbial control – where and why it matters Biofilm basics and how it develops Biofilm impact on “active” surfaces Environmental resistances of biofilm Biofilm impact on purification unit operations and how to control it Good design practices to control biofilm Thank you & Regards, Sean Sharpe, Training Manager, Call us at this Toll Free number: +1-866-978-0800
  • 17 Request Info

    The Importance of Protocol Deviations and Violations to Subject Safety and Data Integrity will Surprise you.The Importance of Protocol Deviations and

    The Importance of Protocol Deviations and Violations to Subject Safety and Data Integrity will Surprise you. Location: Attend Live Webinar Dates: 13-Nov-2015: 1:00 PM EST Duration: 90 Mins Speaker:Charles Pierce, MD. PhD Charles Pierce, MD. PhD, From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 40+ years in the practice of clinical medicine as a family physician. Course Outline: How to know when the protocol is not followed (PNF)? What is the difference between a deviation and a violation? Importance of the “Protocol” in the number of deviations occurring How to ensure that the protocol will be followed exactly? What is in the Regs about following the protocol? When may the Investigator make changes in the protocol? Thank you & Regards, Sean Sharpe, Training Manager, Call us at this Toll Free number: +1-866-978-0800
  • 18 Request Info

    Studies to support Temperature Excursions and Shipping of Pharmaceutical Products

    Studies to support Temperature Excursions and Shipping of Pharmaceutical Products Location: Attend Live Webinar Dates: 04-Nov-2015: 1:00 PM EST Duration: 60 Mins Speaker: Kim Huynh-Ba Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Course Outline: Introduce an overview and complexity of the storage and distribution of pharmaceutical products Review observations on shipping practices Goal of stability studies and environmental factors Establish temperature cycling studies Analytical testing for these products Thank you & Regards, Sean Sharpe, Training Manager, Call us at this Toll Free number: +1-866-978-0800
  • 19 Request Info

    Webinar on FDA Regulation of Medical Device Software

    Overview: The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA). Why should you Attend: To gain a fundamental understanding of FDA regulation of medical device software. Areas Covered in the Session: Definition of medical device software FDA's medical device software regulatory scheme Software validation Level of concern Speaker Profile: Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University. 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/1MCN2jf
  • 20 Request Info

    Webinar on Setting the ideal cGMP HVAC Design Requirements for Pharmaceutical Sterile and Sterile Facilities

    Overview: It was observed that there are misunderstanding between design intent HVAC designer and User (who is working on the field) where each party is focusing on his area! Areas Covered in the Session: GMP Fundamentals of Pharmaceutical HVAC System This part will discuss the benefits of HVAC system in pharmaceutical industries as well as discussing the contamination sources that must be prevented where this section will give information about how bad HVAC can be risky on both process. Speaker Profile: Majdi is dedicated and results-driven Q&V expert with a highly successful background with Pharmaceutical companies in both project and operation fields to achieve the best possible performance through the creation and execution of successful. 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/1Fenw4m