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Courses

  • 1 Request Info

    Webinar on How to Identify Toxic Impurities in Drug Products

    You will learn how to identify and analyse toxic impurities in drug products from active pharmaceutical ingredients. 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/Toxic-Impurities-in-Active-Pharmaceutical-Ingredients-506938/JULY-2019-ES-TRAININGREGISTRY
  • 2 Request Info

    Webinar on How to Prepare for and Manage FDA Inspections

    Attend this webinar to learn how to prepare for an FDA inspection, process of the inspection, roles assigned for these inspections and more. 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/Best-Practices-for-Preparation-for-Behavior-during-and-Response-to-an-FDA-Inspection-502816/JULY-2019-ES-TRAININGREGISTRY
  • 3 Request Info

    Webinar on Preventing Human Error in the Life Sciences

    Explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance. 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/Preventing-Human-Error-in-the-Life-Sciences-509812/JULY-2019-ES-TRAININGREGISTRY
  • 4 Request Info

    Method Development and Validation for Assays Supporting Testing of Biologics:2-Day In-Person Seminar

    Learning Objectives: Understanding the different requirements for small versus large molecules Mapping appropriate timelines with decision points Designing, developing, optimizing, and validating key methods Potency methods, other release and stability methods Preclinical and clinical methods Use of DOE and statistical analysis Handling of critical materials Process monitoring concepts Assessment of orthogonal methods Assessing readiness for validation Defining the validation protocol with real-time capture of data analysis Maintaining quality through documentation Who will Benefit: Below titles working in biopharmaceuticals, pharmaceuticals, natural products/botanicals will be benefited by attending this seminar: Validation Scientists QA/QC Regulatory Affairs Laboratory Managers Assay Development Specialists Statistician CMC Titles Bio Assay
  • 5 Request Info

    FDA Audit, Quality Assurance Practices, Responsibilities and Expectations:2 days in-person Seminar

    It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be inspected and this seminar will help review what are the expectations and the common areas to be familiar with. As a basis for regulatory audits, the quality system, its procedures and their implementation are reviewed to help verify the level of effectiveness in assuring consistent control and quality of materials, components and final product.
  • 6 Request Info

    Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11:2-Day In-Person Seminar

    The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. This is evident in the number of Warning Letter observations and related Import Alerts issued in the last 5-7 years. Data integrity is not a new topic, however, but is a part of the GMPs. Often, companies attempt to address data integrity issues procedurally and by conducting numerous training programs. These tend to be ineffective as data integrity issues are often rooted in a company's culture and may be very difficult to address.
  • 7 Request Info

    Packaging and Labeling in Pharmaceutical Production :2-Day In-Person Seminar

    Pharmaceutical and life sciences companies are under an extreme amount of pressure to maintain an ever-increasing amount of regulation and legislation. With this pressure, they still need to increase efficiencies, bring new products to the market faster, reduce prices, deliver innovation, ensure patient compliance, and maintain business compliance.
  • 8 Request Info

    PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

    The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.
  • 9 Request Info

    Webinar on How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

    Learn how to prepare for an FDA inspection and how to behave during one by attending this webinar by Dr. Loren Gelber. Register Today. 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/How-to-Prepare-for-FDA-Inspections-and-Customer-Audits-of-Pharmaceuticals-505331/May-2019-ES-TRAININGREGISTRY
  • 10 Request Info

    Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation

    The Drug Master File (DMF) is a valuable repository of confidential information which can be stored at the FDA by a product manufacturer in the pharmaceutical industry. The DMF summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product development. FDA guidance documents are available to assist with development of the DMF components, but translating the FDA regulations and guidance documents into actual practices reflecting current product development can be challenging. Expertise and diligence are required to determine which documents need to be created, stored and updated over time in the DMF at the FDA for support of marketing applications made by others using the company product. Note: Use coupon code < REFERRAL10 > and get 10% off on registration.
  • 11 Request Info

    Demystifying Excel Pivot Tables

    Overview We'll begin by helping you ensure that your data is in the right shape to create a pivot table. This is the place most people stop on their journey. Some of the fixes are so simple you'll be amazed. Then, onto actually creating pivot tables, understanding how they are connected and how they interact with the source data from which they are created. From there, you'll learn how to activate features like GETPIVOTDATA functions, charts, graphs, calculated fields, filtering and sorting, and more!
  • 12 Request Info

    A guide to practical Risk Management - Applying ISO14971 and IEC62304

    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.
  • 13 Request Info

    HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

    Overview: Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.
  • 14 Request Info

    6-Hour Virtual Seminar on HIPAA - Emailing, Texting, and Personal Devices

    This six-hour seminar will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission. I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.
  • 15 Request Info

    6-Hour Virtual Seminar on Texting and E-mail with Patients - Meeting Patient

    E-mail has long been a staple of people's lives, but as we move into the new digital age, it seems everyone is moving to a new smart phone and wants to use it in all the incredible ways it can be used for health care purposes, including the use of e-mail and texting. Doctors are finding that texting is far more flexible, convenient, and effective than paging, and patients want to be able to use short message texting for handling of appointments, updates, and the like, where even e-mail or the telephone would seem inconvenient.
  • 16 Request Info

    6-Hour Virtual Seminar on What to do after a Autism Meltdown

    Do you work with children or adolescents with autism who exhibit behaviors that interfere with their ability to effectively and efficiently navigate their environment? They may appear willful, obnoxious, overreactive, anxious, or unfeeling or withdraw. They may lose control of their ability to cope or regulate their behavior which can send them spiraling into a meltdown. You may feel helpless, frustrated, and powerless after each meltdown. Drawing on 45 years of experience and research based strategies, Kathy will lead the viewer with many practical strategies to prevent the meltdown, as well as intervention strategies and how to address post-vention strategies. Many videos demonstrating the examples will be presented to help support and demonstrate the strategy.
  • 17 Request Info

    Seminar on Tougher Import Rules for FDA Imports in 2019

    Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained. Likewise, the U.S. Customs and Border Protection (CBP) must be precise or your entry is not going anywhere. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.
  • 18 Request Info

    6-Hour Virtual Seminar on Upcoming Changes with HIPAA 2019

    This 6-Hour Virtual Seminar will get into the fine details of what we need to do and how to do it. We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers.
  • 19 Request Info

    The Role of Quality Assurance in the Pharmaceutical Industry

    Overview This course is to emphasize the importance of QUALITY in pharmaceuticals: The pharmaceutical environment today is changing quickly due to globalization, increased competition, cost constraint, demands for efficiency, development of international regulation, supply chain complexity, and product/process complexity. In this fast-changing environment, the people and companies that learn to adapt will prosper To manufacture & deliver consistency zero-defect products to the patients.
  • 20 Request Info

    Quality Risk Management Overview 2019

    Why should you Attend: Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system It can provide a proactive approach to identifying, scientifically evaluating and Controlling potential risks to quality Integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization There is much confusion on how to define risk and individuals often think of quality risk management as just a tool like FMEA analysis verses an overall QRM approach This training will explain the important concepts associated with a QRM approach