All seminae Events (68)

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

November 18, 2021 from 9:30am to 4:30pm – online 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… Organized by Complianceonline | Type: seminae

Biostatistics for the Non-Statistician

December 1, 2021 from 10am to 4pm – online This seminar is a thorough review of the basics for those who need a refresher on statistical theory and types of statistical analyses. It gives you the information and skills necessary to understand… Organized by Complianceonline | Type: seminae
Biostatistics for the Non-Statistician

December 1, 2021 from 10am to 4pm – online This seminar is a thorough review of the basics for those who need a refresher on statistical theory and types of statistical analyses. It gives you the information and skills necessary to understand… Organized by ComplianceOnline | Type: seminae
Project Management in Accounting

December 1, 2021 at 10am to December 3, 2021 at 5pm – online This workshop is based on the concept that any business is essentially an integrated system of cash flows driven by management decisions. All analytical tools and related financial/economic concepts… Organized by ComplianceOnline | Type: seminae
HIPAA Breach Evaluation and Reporting - What Qualifies as a Reportable Breach

December 1, 2021 from 10am to 1pm – online There are several steps that must be taken to determine if an incident is a breach, and whether or not that breach is reportable. Determining whether to report or not is not necessarily straightforwa… Organized by ComplianceOnline | Type: seminae

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

December 2, 2021 at 10am to December 3, 2021 at 4pm – online The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appr… Organized by ComplianceOnline | Type: seminae
Medical Device Single Audit Program [MDSAP] Implementation

December 2, 2021 from 11am to 5pm – online Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-… Organized by ComplianceOnline | Type: seminae

Compliance with Environmental, Social, and Governance (ESG) Requirements

December 9, 2021 from 9am to 3pm – online Environmental, Social, and Governance (ESG) has gained increasing attention over the past few years. Today many institutional investors only invest in those companies that provide ESG performance rep… Organized by Complianceonline | Type: seminae

Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines

December 16, 2021 at 10am to December 17, 2021 at 5pm – online Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to h… Organized by ComplianceOnline | Type: seminae

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

January 11, 2022 at 9am to January 12, 2022 at 4pm – online This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirem… Organized by ComplianceOnline | Type: seminae