All ComplianceOnline seminae Events (90)

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

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
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

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
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
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

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

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

January 14, 2021 at 10am to January 15, 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
FDA Recalls - Before You Start, and After You Finish

January 14, 2021 at 8:30am to January 15, 2021 at 2:30pm – online FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall… Organized by ComplianceOnline | Type: seminae

Quality Control Laboratory Compliance - cGMPs and GLPs

January 13, 2021 at 9am to January 14, 2021 at 4pm – online FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries -… Organized by ComplianceOnline | Type: seminae