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Courses

  • 1 Request Info

    Privacy Legislation in the U.S. & European Union

    Overview: Discover the increasing risks, obligations, and steep fines facing organizations who gather and process personal data from individuals in the U.S. and the European Economic Area (EEA).* The GDPR went into effect on the 25 of May 2018; applicable to the 28 Member-States, plus members of the EEA - the GDPR also affects U.S.-based companies that transfer personal data from the EEA to the States.
  • 2 Request Info

    How to Determine the Appropriate Levels and Reporting Categories

    Overview: Change management system should be structured according to the firms Pharmaceutical Quality System (PQS) and should be based on ICH Q8, ICH Q9, and ICH Q10. The change management system should also be designed to cover all aspects of all products and processes utilized at the facility. Thus, any proposed change should undergo a clear and logical evaluation to assure that implemented an item do not affect the current state of control.
  • 3 Request Info

    Regulatory Requirements for Batch Record Review

    Overview: Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
  • 4 Request Info

    Concise SOPs that your (Employees) can Easily Follow

    Overview: Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
  • 5 Request Info

    Webinar on EU General Data Protection Regulation (GDPR): Compliance for Drug development and Clinical Trials

    Attain an understanding of the General Data Protection Regulation (GDPR). Be able to understand the key of the main tenets of GDPR which impact on clinical trials. Consider data breaches. Understand the role of the Data Protection Officer (DPO). Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/EU-General-Data-Protection-Regulation-GDPR-Compliance-for-Drug-development-and-Clinical-Trials-504942/NOVEMBER-2018-ES-TRAININGREGISTRY
  • 6 Request Info

    Addressing CAPA within a Device Quality System

    Overview: This webinar will help you ensure an efficient and effective CAPA 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 webinar is for you.
  • 7 Request Info

    Data Integrity in Clinical Trials in [Latest methods]

    Overview: Clinical trials' data gives an accurate representation of what we measure to evaluate effects of the treatments under comparison. The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in an electronic database. From there, the data subjected to the process of data management is repeatedly inspected to ensure that the data that finally appear in the report are identical to the original, i.e. nothing untoward has happened on the way.
  • 8 Request Info

    Which are Compliant for Inspections for a [GXP Compliance]

    Overview: This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements. Why should you Attend: The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's and other regulatory inspector's inspection observations. This is often caused by poor writing and management and control of SOPs. SOPs need to be easily understood by all those who have to follow them. Well written and effective SOPs are not only a regulatory requirements, they also make good business sense. Too often employees fail to follow SOPs because they can't understand them, and too many times we've seen procedures being constantly revised.
  • 9 Request Info

    R2 Addendum- Changes Impacting Sponsors-CRO-Sites

    Overview: Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development. In 2016, the ICH revised the E6 guidelines to further standardize processes in biomedical products development, decrease redundancies; and reflect the current research landscape such as increases in globalization, study complexity, and technological capabilities.
  • 10 Request Info

    Validation Sampling Plans for Process Validation [Latest]

    Overview: This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including: How to link risk with the confidence statements associated with the sampling plans Identify a variety of sampling plans, that all make the desired confidence statements Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates
  • 11 Request Info

    Webinar on Human Error Prevention in Pharmaceutical Manufacturing

    This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Human-Error-Prevention-in-Pharmaceutical-Manufacturing-503932/SEPTEMBER-2018-ES-TRAININGREGISTRY
  • 12 Request Info

    Implementation and Management of GMP Data Integrity

    Overview: Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
  • 13 Request Info

    Good Documentation Guideline (Chapter 1029 USP)

    This 60-min webinar will familiarize participants with USP Chapter 1029 on good documentation guidelines, And This session will wrap up the general concept and will provide information as to what needs to be documented in certain records, Finally, you will know what kind of information to include in the most popular records dealt with in the manufacturing environment.
  • 14 Request Info

    Secrets to Writing Effective SOPs for Medical Device QMS

    Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.
  • 15 Request Info

    Medical Device Hazard Analysis (ISO 14971)

    In this webinar we will explain in detail the process of conducting a hazard analysis, We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program, Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing.
  • 16 Request Info

    Webinar on Compliance with the CMS Open Payments Rule (Sunshine Act)

    The CMS Open Payments Rule (sometimes referred to as the "Physician Payment Sunshine Act") was born out of the Affordable Care Act. This presentation will walk you through the requirements under the regulation and discuss the logistics and strategies for compliance. 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/Compliance-with-the-CMS-Open-Payments-Rule-Sunshine-Act-504674/AUGUST-2018-ES-TRAININGREGISTRY
  • 17 Request Info

    Webinar on Applying Global Standards to Life Sciences Compliance Documentation

    Learn how to write SOP and work instructions and explore the true purpose and function of compliance documents. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Applying-Global-Standards-to-Life-Sciences-Compliance-Documentation-504874/AUGUST-2018-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar on Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

    Understand the validation and regulatory requirements for the sterile filtration of pharmaceutical products. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Sterile-Filtration-of-Pharmaceutical-Products-Validation-and-Regulatory-Requirements-502453/AUGUST-2018-ES-TRAININGREGISTRY
  • 19 Request Info

    Batch Record Review and Product Release 2018

    Overview: Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
  • 20 Request Info

    Excel Spreadsheet Validation for FDA 21 CFR Part 11

    Overview: Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.