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By onlinecompliancepanel
All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.
By onlinecompliancepanel
A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices.
By ComplianceOnline
This webinar presents a best practices approach for preparing, characterizing and storing cell banks used for GXP analytical and bioanalytical test methods.
By ComplianceOnline
This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach).
By ComplianceOnline
This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.
By Quest CE
Quest CE is offering their Social Media Representative Survey free of charge for firms and their registered representatives.
By Compliance2go
Under regulations now being finalized, Business Associates of HIPAA Covered Entities will be covered directly under the HIPAA regulations, and will have to create HIPAA Privacy, Security, and Breach Notification compliance programs. In addition,
By ComplianceOnline
This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies
By Quest CE
Quest CE, premier provider of insurance continuing education and FINRA firm element training, is proud to announce the promotion of Whitney Hagstrom to Manager of Business Development.
By compliance2go
Medical Records serve many purposes in patient care so any revisions should only be done according to certain procedures and rules, in order to avoid serious compliance consequences.
By ComplianceOnline
This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines.
By ComplianceOnline
The instructor addresses the details of the MDD and includes other significant issues such as the Quality Management System (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MDD Annex X), and the role of harmonized standards.
By compliance2go
This 90 minute webinar will help you gain a detailed overview of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will help prepare you for regulatory inspections in these countries.
By GlobalCompliancePanel
Our services are aimed at benefitting the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries.
By Alex Krenke – QuestCE.com
Quest CE is proud to announce the newest addition to its growing collection of Firm Element compliance training solutions, the anti-money laundering audit assistance tool.
By Alex Krenke – QuestCE.com
Quest CE's Correspondence CE Training allows firms to condense an agent’s state required, multi-hour course into just one hour.
By Alex Krenke
Quest CE is proud to announce their New York 4-Hour Annuities Training Course has been approved and satisfies Regulation 187 for the state of New York.
By ComplianceOnline
This unique hands-on course will provide attendees with risk and control concepts as well as deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.
By subscribe@compliance2go.com
This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data,
By subscribe@compliance2go.com
Enforcement of HIPAA regulations is being stepped up and new fines and penalties make being ready for an audit in advance essential.
By Alex Krenke
Quest CE is proud to introduce Compliance Consultant Programs, the industry’s first fully integrated Firm Element Training and Tracking solution for compliance consultants.
By Alex Krenke
Quest CE is proud to announce their Hawaii Annuities Training Course has been approved and meets the state’s annuity training requirements.
By subscribe@compliance2go.com
This webinar provides step by step instructions on how to design and manage a CAPA system that meets and exceeds compliance requirements
By subscribe@compliance2go.com
FDA-mandated post-market studies are coming. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy
By support@compliance2go.com
During the webinar, we cover topics and provide examples and share personal experiences related to FDA and ISO 14971, Risk Management Process, Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation
By ComplianceOnline
This GCP compliance in Clinical Trials training aims to provide an overview of the parameters critical in ensuring GCP compliance and in doing this, will translate GCP in a more practical, applied sense.
By Compliance2go.com
This webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices. Reduced testing will be viewed from current industry practice, the regulations,
By Compliance2go.com
"Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar.
By ComplianceOnline
In this GCP compliance webinar learn how to prevent and handle protocol deviations and violations
By ComplianceOnline
This 6 hour training course will cover areas of human resources for which supervisors are responsible, such as hiring, performance management, counseling, discipline, terminations

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