All Events in online (13)

Biostatistics for the Non-Statistician

January 20, 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

REACH and RoHS Compliance: Gain a Deeper Understanding

January 21, 2021 at 5:30am to January 22, 2021 at 11:30pm – online This 2 day virtual seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your organization can benefit from the mistakes of others. W… Organized by ComplianceOnline | Type: seminae
Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact

January 21, 2021 at 8:30am to January 22, 2021 at 2:30pm – online FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prep… Organized by ComplianceOnline | Type: seminae
Data Integrity: FDA/EU Requirements and Implementation

January 21, 2021 at 10am to January 22, 2021 at 5pm – online Data integrity has been a focus for pharmaceutical regulatory inspections for a number of years and look set to remain of concern to regulators and manufacturers for many years to come. Many inspecti… Organized by ComplianceOnline | Type: seminae

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

January 27, 2021 at 9am to January 28, 2021 at 3pm – online This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems… Organized by ComplianceOnline | Type: seminae
21 CFR Part 11 Compliance for SaaS/Cloud Applications

January 27, 2021 at 9am to January 28, 2021 at 3pm – online This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems… Organized by ComplianceOnline | Type: seminae

Change Control Best Practices - Avoiding Unintended Consequences of Changes

January 28, 2021 at 6am to January 29, 2021 at 12pm – online One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation… Organized by ComplianceOnline | Type: seminae

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

February 3, 2021 at 10am to February 4, 2021 at 5pm – 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

FDA's Medical Device Software Regulation Strategy

February 9, 2021 at 8:30am to February 10, 2021 at 2:30pm – online The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a dev… Organized by ComplianceOnline | Type: seminae

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

February 16, 2021 at 7am to February 17, 2021 at 1pm – online The globalization of the pharmaceutical supply chain has resulted in the increased use of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it also present… Organized by ComplianceOnline | Type: seminae