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Courses

  • 61 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
  • 62 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).
  • 63 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.
  • 64 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.
  • 65 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.
  • 66 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.
  • 67 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
  • 68 Request Info

    Data Integrity: FDA/EMA Requirements and Implementation : 2-Day In-Person Seminar by Ex-FDA Director

    The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pharmaceutical regulatory authorities have. Enforcement penalties can be severe from a business standpoint, and in extreme cases can even impact individuals who are held responsible for the occurrence of data integrity problems. In recent months the topic of data integrity has been in the forefront of concern among worldwide pharmaceutical regulatory agencies. The FDA, EMA, TGA and others have published guidelines setting forth their requirements and expectations for the maintenance of data integrity, as has at least one leading industry organization (PDA).
  • 69 Request Info

    Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

    Overview It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
  • 70 Request Info

    Design of Experiments (DOE) for Process Development and Validation 2017

    Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product. The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes. Screening designs, such as 2k factorial and D-optimal designs, are used to determine critical process parameters. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901126SEMINAR?trainingregistry-September-2017-SEO
  • 71 Request Info

    DESIGNING A PHARMACEUTICAL QUALITY SYSTEM: An in-depth examination of ICH Q10 and the companion documents (ICH Q8, Pharmaceutical Development and ICH

    The Purpose of this Course is to Review ICH Q10, which is a Document developed by the 3 Countries Comprising ICH (Us, Eu, Japan). ICH Q10 is for the Development of a Pharmaceutical Quality System, In Conjunction with the Companion Documents, ICH Q8, Pharmaceutical Development and ICH Q9, Quality Risk Management. In Addition to the Members of ICH (Us, Eu And Japan), Many Other Groups were involved in the Expert Working Committees that were involved in the Development of these Documents, Etc Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901546SEMINAR?trainingregistry-April-2018-SEO
  • 72 Request Info

    Developing a Regulatory Strategy for Product Development

    This session will discuss key strategies to develop a targeted regulatory strategy for managing an effective product development program. The session will provide tips on team building, creating product development plans, choosing your regulatory pathway, regulatory authority interactions, and partnership strategies, while also including case studies to illustrate how these tips can prevent common pitfalls and lead to success.
  • 73 Request Info

    Developing HIPAA Policies and Procedures

    Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. A HIPAA Risk Management plan is your overall policies and procedures manual. If audited or the subject of a compliance review you will be required to show the government you have all the necessary policy and procedure documentation in place to address all the required safeguards.
  • 74 Request Info

    Device Changes, FDA Changes, and the 510(k)-2019

    Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?
  • 75 Request Info

    Differences Between an FDA and MHRA Audit

    Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
  • 76 Request Info

    Diversity and Inclusion 101

    Overview Diversity and inclusion are common buzzwords these days but few understand what they really mean or entail. In this webinar, we will explore what diversity and inclusion REALLY are as well as common myths and misconceptions. We will discuss everything from implicit and explicit bias, diversity in areas you haven't thought of, intent vs. impact, and calling in vs. calling out and more.
  • 77 Request Info

    Does your CAPA Program Need a CAPA | Seminar CAPA 2018

    This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you. We'll discuss regulatory requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We'll discuss best practices so you can start off on the right foot and always be prepared for an inspection.
  • 78 Request Info

    Drug dissolution testing and establishing plasma drug levels in humans

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901306SEMINAR?trainingregistry-December-2017-SEO
  • 79 Request Info

    Drug Products for Clinical Trials | FDA Approved Drugs List 2018

    In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR parts 210 and 211). Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901549SEMINAR?trainingregistry-March-2018-SEO
  • 80 Request Info

    eCTD Submissions of IND/NDA to the US FDA, EU and Canada

    The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901660SEMINAR?trainingregistry-April-2018-SEO