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Courses

  • 341 Request Info

    Webinar On Challenges with the NOTICE Act and the MOON Form: Is your Hospital/CAH Facility Ready for the Upcoming March 8 Implementation

    CMS has recently posted its updated version of the Medicare Outpatient Observation Notice (MOON), a standard notice that all hospitals and critical access hospitals must provide to Medicare beneficiaries who receive outpatient observation services for more than 24 hours. All hospitals and critical access hospitals (CAHs) are required to provide the MOON beginning no later than March 8, 2017.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/CHALLENGES-NOTICE-ACT-MOON-FORM-502058/FEBRUARY-2017-ES-TRAININGREGISTRY
  • 342 Request Info

    Webinar On Chronic Care Management: Boosting Revenue of your Practice and Improving Patient Care

    This course will explain in detail the Medicare Chronic Care Management initiative. Medicare estimates that approximately two thirds of all Medicare patients are eligible for this program. Medicare will pay clinicians an average of approximately $43 a month for providing 20 minutes or more of non-face-to-face management services for patients with two or more chronic medical conditions.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/CHRONIC-CARE-MANAGEMENT-501936/DECEMBER-2016-ES-TRAININGREGISTRY
  • 343 Request Info

    Webinar On Clinical System Data Management Validation

    Have you validated your clinical data base? Do you have the proper documentation in the event of a regulatory inspection? In this course we will cover considerations and requirements for validation of clinical data management systems. We will discuss the challenges and strategies of risk based validation and review 21 CFR Part 11 expectations. We will discuss the importance of a change control process.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-DATA-MANAGEMENET-501926/DECEMBER-2016-ES-TRAININGREGISTRY
  • 344 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
  • 345 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
  • 346 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
  • 347 Request Info

    Webinar On Considerations for Human Factors Evaluations of Combination Products

    The basic principles of human factors engineering can be applied universally to improve the safety and usability of any medical product. However, each product still has its own unique considerations. Combination products or medical devices that include a drug or biological components, can introduce concerns that do not necessarily apply to non-drug devices. To ensure that product design is optimized, it is important to take a product's specific needs into consideration. This course describes how to apply human factors principles to the design and development of combination products while also maximizing safety and meeting the expectations of the FDA..Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/HUMAN-FACTORS-EVALUATIONS-COMBINATION-PRODUCTS-502265/AUGUST-2017-ES-TRAININGREGISTRY
  • 348 Request Info

    Webinar on Developing an Effective CAPA Program for GMP Operations

    Overview: Having an effective CAPA documentation and tracking system are crucial to pharmaceutical operations. This system will allow personnel to identifying the root cause, corrective action taken, and verification stages. This session will discuss important components to create an effective CAPA system, determine different levels of actions to be taken, and training needed to prevent reoccurrence.
  • 349 Request Info

    Webinar on Development and Implementation of an External Auditing Program as part of a Pharmaceutical Manufacturing Quality System

    Overview: The presentation will explain the need and implementation of a pharmaceutical manufacturing external auditing program as part of an overall GMP compliant Quality System. Why should you Attend: The use of chemical and material suppliers, contract manufacturers and contract testing lab is integral in today’s pharmaceutical manufacture. With ever increasing diversity of WW suppliers and complexity in the regulatory and scientific realm of pharma manufacture. Speaker Profile: Joseph Habarta Ph.D. is founder and principal of J. Habarta Consulting that provides specialized consulting and assistance in the areas of international GMP and quality for the biotechnology and pharma industries. 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/1OFoeuk
  • 350 Request Info

    Webinar On Device Accessories - Understanding and Implementing the Final Guidance Document

    The classification of device accessories has a high visibility. For example, the 21st Century Cures Act, signed into law in December 2016, amends the FD&CA; to include accessory classification. It is very important, as a result, to apply the guidance document to your firm's products to determine if any of them are an accessory and as a result, ensure they meet the device regulations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/DEVICE-ACCESSORIES-505201/AUGUST-2017-ES-TRAININGREGISTRY
  • 351 Request Info

    Webinar on Drug Product Stability and Shelf-Life

    This presentation covers the design and execution of stability studies in support of the establishment of retest dates for clinical materials and expiration dates for commercial materials. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Drug-Product-Stability-and-Shelf-Life-504782/JANUARY-2018-ES-TRAININGREGISTRY
  • 352 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
  • 353 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
  • 354 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
  • 355 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
  • 356 Request Info

    Webinar On Enhancing your CAPA Program by Developing a Learning Organization

    This Webinar provides tools needed to sell a meaningful CAPA program up to Management, by discussing how CAPA can be used as a tool to yield business results. This well-researched webinar references classic business literature, written by famous business minds, such as Peter Drucker and Peter Senge, to describe how a CAPA program appeals to the needs of Knowledge Workers in a Learning Organization, CAPA therefore becomes a business tool to un-learn behaviors that are thwarting progress in the organization, and becomes a tool for sustainable change, organization alignment and business risk management.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/ENHANCING-CAPA-PROGRAM-LEARNING-ORGANIZATON-501459/JUNE-2016-ES-TRAININGREGISTRY
  • 357 Request Info

    Webinar On Ensuring Compliance with ICH GCP E6 (R2) Requirements: Meeting the challenges of RBM

    This training will look at the principles of risk management and how they apply in RBM. We will look at the changing regulatory environment with a focus on the changes outlined in ICH GCP E6 (R2) and how these changes may impact your clinical trials.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-ICH-GCP-E6-R2-501987/DECEMBER-2016-ES-TRAININGREGISTRY
  • 358 Request Info

    Webinar on Establishment of Quality Systems

    Overview: Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.
  • 359 Request Info

    Webinar on Extending Your Drug's Life

    Overview: This course will describe how a pharmaceutical company can prolong the life of a drug product. The high cost of time, money, and man-hours to develop a new pharmaceutical drug requires that the company hang onto the drug especially during the patent period. Why should you Attend: Healthy pharmaceutical companies take pride in adding years to a pharmaceutical product's life. People who are responsible for this result are often promoted because of the positive effect on the company's health. Speaker Profile: Bob Kunka Ph.D. is an accomplished and respected scientist who contributed to the development of 28 approved pharmaceutical products in eight therapeutic areas. His expertise on international product development teams produced submissions. 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/1gLXQjC
  • 360 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