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Courses

  • 41 Request Info

    Aware of the Similarities and Differences in the files

    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. Why should you Attend: companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier.
  • 42 Request Info

    Best Practices for Applying ISO14971 and IEC62304 in Zurich

    Overview: 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. Location: Zurich, Switzerland Date: May 18th & 19th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Hilton Zurich Airport Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate) Until April 10, Early Bird Price: $1,695.00 from April 11 to May 16, Regular Price: $1,895.00 Register for 5 attendees Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)* Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900892SEMINAR?channel=mailer&camp=seminar&AdGroup=trainingregistry_May_2017_SEO
  • 43 Request Info

    Best Validation Practices for Laboratory Computer Systems Regulated by FDA

    Overview We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA. Any “GxP” system (i.e., the system "touches" product during the laboratory testing or process) must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. This FDA Compliance course will describe the best practices for conducting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done. In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators. For more detail please click on this below link: http://bit.ly/2r9k1XA Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515
  • 44 Request Info

    Biostatistics for the Non-Statistician: 2-Day In-Person Seminar

    Who will Benefit: Persons working in the medical or health sciences, pharmaceutical and or nutriceutical industries, clinical trials, clinical research, and clinical research organizations, physicians, medical students, graduate students in the biological sciences, researchers, and medical writers who need to interpret statistical reports. Physicians Clinical Research Associates Clinical Project Managers/Leaders Sponsors Regulatory Professionals who use statistical concepts/terminology in reporting Medical Writers who need to interpret statistical reports Clinical research organizations, hospitals, researchers in health and biotech fields.
  • 45 Request Info

    Budgeting and Forecasting Physician Practices with Ease and Quality

    Overview: Strong budgeting and forecasting is about getting the fundamentals right. This webinar will teach you which areas to focus the majority of your time and effort in order to achieve the best results. Examples of high-quality detailed volume and physician compensation templates will be shown in order to illustrate the level of detail necessary to create a budget you will not be nervous to show your boss, banks, corporate office, or partners.
  • 46 Request Info

    Burning up while Burning out - Compassion Fatigue Awareness & Burnout Prevention for Practitioners

    Overview: Healthcare professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs, reduced staffing, and diminishing resources. Many healthcare workers are putting in longer hours and for less pay. From working twenty-four shifts to simply burning the midnight oil catching up on paperwork, the healthcare industry puts a great deal of stress and fatigue on the average worker and their relationships, including family. Healthcare professionals bare witness to human suffering on a routine basis and are constantly reminded that tragedy, pain, and challenge often loom large in the midst of helping patients heal. As a result, compassion fatigue and burnout are major hazards of the profession that are becoming far too common.
  • 47 Request Info

    Burning up while Burning out - Compassion Fatigue Awareness & Burnout Prevention for Practitioners

    By attending this webinar Participants will gain awareness of key signs and symptoms of compassion fatigue and burnout, while learning how to manage stressors and their consequences, This webinar focuses on understanding each of these challenges, their similarities and differences.
  • 48 Request Info

    Business Continuity Planning for [Computer Systems] Operations

    Overview: Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries. Disaster recovery activities often include efforts to deal with both system functionality and data integrity, quality, accessibility and accuracy. Business continuity activities often include efforts to deal with system functionality and data integrity, quality, accessibility and accuracy, but the focus is on getting the business processes running in the absence of a sound system or data.
  • 49 Request Info

    C-TPAT - Trade Partnership Against Terrorism 2018

    In this webinar, we will explore the best approach to C-TPAT certification and discuss best practices, and The attendees will learn how to develop a standard approach to complying with the voluntary C-TPAT guidelines, and Strategies for reducing the cost and complexity of compliance with C-TPAT.
  • 50 Request Info

    CE Mark Certification: Compile a CE Marking Technical File (or Design Dossier for Class III) containing evidence of compliance to the Medical

    Why you should attend Introductions and overview of the EU Directives Identify the EU Directives and standards applicable to your product Comply with the implementation details and requirements of the EU MDR & IVDR Design a new product, or evaluate an existing product, for conformity with these Directives and standards
  • 51 Request Info

    cGMPs in the Quality Control Laboratory (Medical 2018)

    Overview: Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations. By careful review and analysis of the regulations, inspectional guidance, 483 observations and Warning Letter, internal audit observations and deviations, along with a review of laboratory practice and procedures, a laboratory can proactively identify areas for improvement.
  • 52 Request Info

    Challenges of Using Cloud in a Regulated Environment

    This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
  • 53 Request Info

    Changing Trend in Risk Allocation - Differing Site Conditions

    Overview This webinar discusses the definition of a differing site condition and why there is a need for a Differing Site Conditions clause in a construction contract. The webinar sets forth the history and purpose of the clause and examines the modern Differing Site Conditions clauses and the changes over time. Why should you Attend This webinar provides a thorough discussion of the Differing Site Conditions clause and how the typical understanding of this 90 year old clause is being eroded by Court and Board decisions. The differing site conditions clause was created by the U.S. Federal government in 1926, in regards to construction contracts. Over the years, the Courts and Boards of Contract Appeals have been slowing changing the interpretation of risk allocation under the clause. A series of Court and Board cases have increased the contractor’s risk concerning differing site conditions.
  • 54 Request Info

    Clinical Data Management (FDA E6 GCP Guidelines)

    Learning Objectives: Regulatory guidelines for Clinical Data Management Best practices for data collection CDISC/CDASH/STDM standards Responsibilities of personnel Case report form criteria Maintaining confidentiality of data Data storage and transferability Data preparation and quality assurance for accuracy Data monitoring plan criteria Data systems validation Adverse event reporting and coding criteria What to expect on a monitoring visit Troubleshooting and resolution of deviations from plan Who will Benefit: Study Investigators Data managers Data processors Statisticians Site Personnel Clinical Research Associates Clinical Project Managers/Leaders Study Sponsors Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management Staff in the above fields who work with data collection/management and require training in CDM. Compliance auditors and regulatory professionals who require a knowledge of CDM in asse
  • 55 Request Info

    Clinical Data Systems Regulated by FDA

    Overview: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction. Why should you Attend: You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. This webinar will also benefit those involved in the conduct of clinical trials, audit and inspection of clinical trial study data and records, and submission of filings to regulatory agencies that involve clinical trial data.
  • 56 Request Info

    Combination Products

    This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing
  • 57 Request Info

    Combination Products 2017

    This seminar provides Professionals working in this area with A thorough understanding of the complexities involved All the relevant regulations and guidelines Real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901066SEMINAR?trainingregistry-September-2017-SEO
  • 58 Request Info

    Complaint and Recall Management Seminar 2018

    This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Attention will be paid to the application of risk management to a complaint handling system, and a specific risk management system explained.
  • 59 Request Info

    Complaint and Recall Management: A Compliant, Lean Program

    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, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback.
  • 60 Request Info

    Complaint and Recall Management: A Compliant, Lean Program 2017

    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! Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901336SEMINAR?trainingregistry-November-2017-SEO