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Courses

  • 301 Request Info

    Webinar on Implementation of Risk Evaluation and Mitigation Strategy (REMS) - What do you need to do now?

    Attendees will receive knowledge on important and essential requirements related to Risk Management for potential pharmaceutical adverse effects. This webinar will provide basic understanding of requirements for REMS and steps to consider for implementation. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Implementation-of-Risk-Evaluation-and-Mitigation-Strategy-REMS-What-do-you-need-to-do-now-507343/DECEMBER-2017-ES-TRAININGREGISTRY
  • 302 Request Info

    Webinar on Veterinary Pharmacy Law and Occupational Safety Training in Veterinary Medicine

    The goal of this course is to help the learner to understand the laws that apply to filling prescriptions for animals, and to provide resources for finding answers to veterinary pharmacy situations. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://onlinecompliancepanel.com/webinar/VETERINARY-PHARMACYY-LAW-AND-OCCUPATIONAL-503173/NOVEMBER-2017-ES-TRAININGREGISTRY
  • 303 Request Info

    Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2018

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901453SEMINAR?trainingregistry-January-2018-SEO
  • 304 Request Info

    Product Reliability Training Courses | Product Reliability Testing

    Although a primary objective of reliability analysis is to improve product reliability, there are many possible reasons for collecting and analyzing reliability data. Several examples are the following: Assessing product reliability in the field Predicting product warranty costs Estimate replacement part/spares requirements Assessing the effect of a proposed design change Demonstrating product reliability to customers or government agencies Comparing components from multiple suppliers Comparing components from different production periods, operating environments, or materials Improving reliability through the use of laboratory experiments keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901438SEMINAR?trainingregistry-January-2018-SEO
  • 305 Request Info

    Internal Audit Checklist for Medical Devices | Quality Audit

    Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS. In this workshop, participants examine the various types of audits to understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2nd party) play a role in an effective supplier management program; your company could be the subject of the audit. Independent audits (3rd party) can help provide assurance about the health of a QMS. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901429SEMINAR?trainingregistry-January-2018-SEO
  • 306 Request Info

    21 CFR Part 11 Validation Checklist | Computer Systems Validation

    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901300SEMINAR?trainingregistry-January-2018-SEO
  • 307 Request Info

    Complaints and Recalls | Complaint Handling System in Boston 2018

    Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901339SEMINAR?trainingregistry-January-2018-SEO
  • 308 Request Info

    Verification vs. Validation - Product Process Software and QMS 2018

    This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901450SEMINAR?trainingregistry-January-2018-SEO
  • 309 Request Info

    What is the HIPAA Compliance | HIPAA Privacy Compliance Training 2018

    This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project. At the end of these presentations there will be a workshop to demonstrate how to use these tools. keep enhancing: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901762SEMINAR?trainingregistry
  • 310 Request Info

    FDA General Principles of Software Validation | Cyber Security 2018

    Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. The FDA looks at software in one of three ways: Standalone, such as for a mobile app; device-based software used to control a device's performance, or simply electronic records. FDA's risk classification will gradually clarify keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901393SEMINAR?trainingregistry-January-2018-SEO
  • 311 Request Info

    Principal Investigator Responsibilities in Clinical Research | GCP 2018

    This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is know as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trails that provides assurance that the data and reported results are credible and accurate and, most importantly, that the safety, rights, integrity, and confidentiality of trial subjects is protected. That all members of the team must know and practice "GCP" guarantees, that the Protocol is followed, that the Informed consent is complete, that the study conduct is according to the protocol, keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901351SEMINAR?trainingregistry-January-2018-SEO
  • 312 Request Info

    What is Computerized Testing Systems | GxP Compliance Testing 2018

    Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11. "Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error handling should be considered" The regulated company is responsible for demonstrating compliance and fitness for use. Effective testing demonstrates compliance with regulatory requirements and ensures patient safety, product quality and data integrity as a result of controlling identified risks. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901363SEMINAR?trainingregistry-January-2018-SEO
  • 313 Request Info

    Medical Device Software Risk Management Standard | Software Expert 2018

    Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world. Regulatory bodies are placing increased emphasis on risk management, and technology shifts are introducing new sources of risk. Newer Lean-Agile methods are recognized by the FDA as a good way to accomplish risk management. Techniques for risk management are well established, but require specific interpretation when applied to software. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901345SEMINAR?trainingregistry-January-2018-SEO
  • 314 Request Info

    What is Project Management in Pharmaceutical Industry Seminar

    Project management is a discipline that can be applied to all industries. In the pharmaceutical industry, project management is the key to addressing the unique regulatory, compliance and quality related needs of the industry. The process of clinical research and drug development, coupled with the critical issue of time to market, can use project management techniques to effectively apply scheduling, risk management, and comprehensive quality assurance and control to the process of bringing a drug to market in a safe, effective & cost-efficient way Every industry has different "stress points"-those points that are most critical to the specific product or service being delivered. The most typical stress points are schedule, cost, and quality. Depending on the project keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901435SEMINAR?trainingregistry-January-2018-SEO
  • 315 Request Info

    What is Process Validation Report | 21CFR11 Compliance Checklist 2018

    Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901447SEMINAR?trainingregistry-January-2018-SEO
  • 316 Request Info

    How the New Rules for the Sanitary Transportation

    Overview: This webinar is designed to help you understand how the new rules for the sanitary transportation of human and animal foods will impact your logistics operations and to provide you with some of the tools needed to meet new regulations and customer demands.
  • 317 Request Info

    Why are we Seeing More Independent Data

    Overview: All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data. Safety monitoring is mandated in 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices.
  • 318 Request Info

    New Import Program for FDA 2017

    Overview: The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.
  • 319 Request Info

    HIPAA - How Business Associates Can Comply Calmly, Confidently and Completely 2017

    HIPAA Rules are easy to follow, step-by-step, once you know the steps. In this seminar Paul Hales will capture your attention with visual presentations, exercises and discussion that explain HIPAA compliance in plain language. And he will show you how to find the exact steps - when you need them - to comply with every topic in the HIPAA Privacy, Security and Breach Notification Rules Key Takeaways: Clear Understanding of the HIPAA Privacy, Security, Breach Notification Rules What they are - How they work together to affect Business Associates and Covered Entities (Health Care Providers, Health Plans and Health Care Clearinghouses) Origin of the HIPAA Rules - How they are changing - What to expect next How the HIPAA Rules affect and specifically apply to Business Associates Specific HIPAA Compliance Requirements for Business Associates Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901390SEMINAR?trainingregistry-December-2017-SEO
  • 320 Request Info

    Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing 2017

    The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901366SEMINAR?trainingregistry-December-2017-SEO