BioPharmaceutical

This webinar provides information that will identify and correct common issues that may arise during validation of methods required in drug development. 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/Common-Problems-and-Mistakes-in-Method-Validation-in-Drug-Development-Process-505094/JULY-2018-ES-TRAININGREGISTRY

This seminar addresses the integrity of GxP records and data used within the regulated industries including pharmaceutical, biological, medical devices, cosmetics, food and any other industry where data integrity is important. It provides a method for managing risk to record and data integrity. Learning objectives for the seminar include: data integrity Requirements Critical Areas of Regulatory Focus and Concern Key Concepts A Framework for data integrity and Human Factors A Complete Data Life Cycle Approach as Part of a Quality Management System, from Creation to Destruction How to Apply Risk Management to data integrity

Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Topics: FDA's risk-based regulatory strategy Cybersecurity Interoperability National Institute of Standards and Technology Voluntary standards and programs Mobile Apps Premarket software validation and design requirements Postmarket Software recalls

This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with Computer Systems Validation as follows: What is 21 CFR 11/Annex 11 and Computer Systems Validation and how is it implemented How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance? Data Integrity Frequently Asked Questions Validation Master Plan Risk Based Assessment Complete Validation for a System (software development lifecycle) Equipment Qualification Infrastructure Requirements Change Control SOPs

Course Objectives: Understand what is expected in Part 11 and Annex 11 inspections Avoid 483 and Warning Letters Learn how to buy COTS software and qualify vendors. Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds Requirements for local, SaaS, and cloud hosting How to select resources and manage validation projects "Right size" change control methods that allows quick and safe system evolution Minimize the validation documentation to reduce costs without increasing regulatory or business risk Write test cases that trace to elements of risk management Protect intellectual property and keep electronic records safe

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

This webinar will be focused on processes and approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials. The ability to develop robust budgets, ensure billing compliance and adherence to CMS-Medicare regulations for clinical trials remains a challenge for many clinical sites, sponsors and Contract Research Organizations (CROs).

The seminar will close with a discussion of three case studies that will showcase and make real the many concepts presented. Throughout the seminar, activities will be presented that will reinforce all learned concepts. Every opportunity will be provided for a sharing of ideas and a discussion of the concepts presented. Printed handouts and pamphlets will be provided to document seminar content and to provide participants with take-away material.

To ensure Data Integrity, a GxP regulated company needs to abide by principles, current regulations and industry best practices on the expectations for the management GxP regulated records and data. These principles, regulations and best practices, ensure that data is complete, consistent, accurate, secure and available throughout the record life cycle. This approach is intended to encourage innovation and technological advances while avoiding unacceptable risk to product quality, patient safety and public health.

This 2-Day seminar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

This Seminar addresses the integrity of GxP records and data used within the regulated industries including pharmaceutical, biological, medical devices, cosmetics, food and any other industry where Data Integrity is important. It provides a method for managing risk to record and Data Integrity. Learning Objectives for the seminar include: Data Integrity Requirements Critical Areas of Regulatory Focus and Concern Key Concepts A Framework for Data Integrity and Human Factors A Complete Data Life Cycle Approach as Part of a Quality Management System, from Creation to Destruction How to Apply Risk Management to Data Integrity

Join this webinar that outlines the origins and risks of spores, strategies to reduce incidents and incorporation of sporicidal agents into the contamination control program. 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/The-Problem-of-Bacterial-Spores-and-Sporicidal-Disinfection-507982/MAY-2018-ES-TRAININGREGISTRY

This webinar will examine the implications of the Sunshine Act for healthcare providers and life science companies. 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/Sunshine-Act-Reporting-Clarification-for-Clinical-Research-508714/MAY-2018-ES-TRAININGREGISTRY

Ninety minutes webinar on the Best Practices for Implementing an Effective Cleaning Validation. The speaker will also explain ASTM E3106 for Cleaning Validation. 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/Best-Practices-for-Implementing-an-Effective-Cleaning-Validation-using-Principles-of-Upcoming-ASTM-E3106-509617/MAY-2018-ES-TRAININGREGISTRY

Attend this webinar to learn how the new FDA Guidance on Elemental Impurities is related to ICH Q3D and USP Chapters 232 and 233. 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/New-Elemental-Impurities-Tests-for-Pharmaceutical-Products-According-to-the-New-ICH-Q3D-and-USP-232-233-Guidelines-505938/MAY-2018-ES-TRAININGREGISTRY

This webinar covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems. 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/Data-Integrity-Compliance-for-GXP-in-the-Biopharma-Industry-504145/MAY-2018-ES-TRAININGREGISTRY

In this webinar speaker will examine the risks posed by fungi to pharmaceutical products and remediation measures to remove, eliminate and to prevent fungi. 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/Fungal-Contamination-and-Pharmaceutical-Products-Recall-509707/APRIL-2018-ES-TRAININGREGISTRY

Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation. 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/Validation-of-Complex-Cell-Based-Potency-Methods-503812/MARCH-2018-ES-TRAININGREGISTRY

The Centers for Medicare and Medicaid Services (CMS) has promulgated requirements for hospitals to prevent ligature risk and self harm from patients that are suicidal. A 13 page memo was issued and the hospital manual was amended on December 29, 2017 to implement these changes. Any hospital that received Medicare, which is most hospitals in America, must implement these changes for all patients. 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/Ligature-Risks-Ensuring-Compliance-with-the-CMS-Hospital-CoPs-and-TJC-Requirements-504204/MARCH-2018-ES-TRAININGREGISTRY

The European Union (EU) currently has around a decade of experience with biosimilars. The first wave of biosimilars comprised simple biologics, such as somatropin, erythropoietin and filgrastim. The European Commission (EC) granted marketing authorization for 14 biosimilars between April 2006 and June 2010. The approval of the first monoclonal antibody (mAb) biosimilar in 2013 - Inflectra/Remsima from then Celltrion and Hospira - marked the beginning of the second wave of approvals and the first of the more complex biosimilars. 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/Biosimilars-from-Development-to-Registration-504679/MARCH-2018-ES-TRAININGREGISTRY