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Courses

  • 61 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
  • 62 Request Info

    Complete 1099, TIN Matching, B-Notice, 1042-S Non-resident Alien and FATCA Compliance Update

    For years the IRS has struggled with the independent contractor, the non-resident alien worker, US citizens with foreign financial accounts and tax collection. They have placed the burden on businesses, non-profits and not-for-profits as well as state and local government to report information about taxable payments they make to their account holders, vendors and customers. In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding information reporting on taxpayers by payers - the 1099 and the 1042-S. These time consuming reporting obligations can be streamlined in a number of ways. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901531SEMINAR?trainingregistry-April-2018-SEO
  • 63 Request Info

    Compliance Boot Camp 2017

    This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901152SEMINAR?trainingregistry-November-2017-SEO
  • 64 Request Info

    Compliance for Computer Systems Regulated by FDA

    The seminar 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.
  • 65 Request Info

    Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Overview: Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.
  • 66 Request Info

    Compliance with the New ICH GCP Revision 2 Addendum - Know the How?

    Overview This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites. This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally.
  • 67 Request Info

    Compliance with the New ICH GCP Revision 2 Addendum - Know the How?

    Overview This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites.
  • 68 Request Info

    Complying with the Revenue Recognition Standard

    This course is designed to provide an overview of the technical guidance and outline the five steps involved in the revenue recognition model, we will also explore some concepts to consider within each step and then evaluate some challenges that specific industries may have when complying with the standard.
  • 69 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?
  • 70 Request Info

    Contingency Operation & Disaster Plan: What HIPAA Requires for your Practice

    HIPAA requires you to have both a Contingency Operations Plan and a Disaster Recovery Plan in place. In case you are wondering, being on a cloud-based EHR is not a Disaster Recovery Plan.
  • 71 Request Info

    Control-Analysis Instrumentation used in PAT Continuous [Manufacturing]

    Overview: We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products. Also discuss will be how to build the PAT/CM team and set goals, budgets, and make the change-overs smoothly and efficiently. Requirements for PAT/CM equipment: Speed, Precision, ease of use/installation/calibration/validation Types of Equipment: Near-Infrared, Raman, TeraHertz, (for biopharma) Ultra-fast LC Personnel needed: Engineers, Analytical Chemists, Statisticians, Chemometricians
  • 72 Request Info

    Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

    Overview All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Life science manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records. Prior to computer systems and databases, managers and quality personnel created complex visual numbering systems and separate files for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences. As is often the case, automation and computers do not always replace the legacy policies and rules that were necessary with manual and paper systems but are now obsolete.
  • 73 Request Info

    Controlling human error in the manufacturing floor

    OVERVIEW Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. For more detail please click on this below link: http://bit.ly/2v1A8Zz Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510
  • 74 Request Info

    Countdown to MACRA: It's Time for Physicians to Pick Their Pace for 2017

    On October 14th CMS published the final rule that outlines its implementation of MACRA value-based payment reform starting in 2017. The new framework is called the Quality Payment Program. Going forward, clinicians and health care leaders need to be developing strategies so they can position their organizations for financial success under the new Quality Payment Program. Beginning in 2017, CMS will start rewarding clinicians for their delivery of high-quality patient care through one of two pathways: (1) payment of incentives for participation in Advanced Alternative Payment Models (Advanced APMs); or (2) application of a positive or negative adjustment pursuant to the clinician's performance under the new Merit-based Incentive Payment System (MIPS).
  • 75 Request Info

    Course Online Introduction to ECG (EKG)

    We offer a fully accredited, self-paced online Introduction to Electrocardiography (ECG) course. This course combines an interactive study experience with the convenience of the Internet. Master the principles of electrocardiography with our online Introduction to ECG course.
  • 76 Request Info

    CPT and HCPCS Updates for Pain Management

    In this webinar we will discuss the most recent CPT changes as well as review past CPT updates to commonly performed pain management services, Also we will discuss HCPCS codes and how to best find the medication we are looking for.
  • 77 Request Info

    Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems

    Overview Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.
  • 78 Request Info

    Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems

    Overview: Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive. Though some excursions are real and a sign of system control problems, most are probably self-inflicted, being caused by poorly designated "trigger values", poorly designed use points, or poorly executed sampling or testing. This presentation will explore these possible causes, including the symptoms of real (as well as false) water system problems, and provide effective alternatives to avoiding most of your current superfluous excursions, as well as how to build supporting data useful in pinpointing causes when investigations are indeed necessary.
  • 79 Request Info

    Customs-Trade Partnership Against Terrorism (C-TPAT) Supply Chain Security and Compliance for Regulated Industries

    The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against the threat of terrorism. The program was launched in November 2001, with seven large U.S. companies as the initial participants. By the end of 2014, more than 10,000 members joined the effort. More than 4300 importers in the program account for more than half of the value of all merchandise imported into the U.S. C-TPAT certification can be attained by companies who seek to be considered low risk, enabling their cargo to be processed in an expedited manner with fewer Customs examinations. The certification involves a documented process for determining and mitigating risk throughout a company’s international supply chain. The program is voluntary, but affords those participating in it a huge advantage in terms of international trade.
  • 80 Request Info

    Data Integrity, 21 CFR 11 & Annex 11 Implementation 2017

    The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News Overview and Key Requirements of Part 11 & Annex 11 How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901052SEMINAR?trainingregistry-December-2017-SEO