All seminae Events (68)

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

March 16, 2022 at 8am to March 17, 2022 at 2pm – 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

March 16, 2022 at 8am to March 17, 2022 at 2pm – 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

Process Validation Guidance Requirements

March 31, 2022 at 10am to April 1, 2022 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

SOP Writing, Training and Compliance in the Pharmaceutical Industry

April 18, 2022 at 10am to April 19, 2022 at 5pm – online Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the exten… Organized by ComplianceOnline | Type: seminae

Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

April 21, 2022 at 9am to April 22, 2022 at 5pm – online The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. This new regulation is also stronger connected to the EN ISO 13485:2016. The understanding of th… Organized by ComplianceOnline | Type: seminae

REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

April 28, 2022 at 7am to April 29, 2022 at 1pm – 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

How FDA trains its investigators to review CAPA and what should you do to prepare

May 4, 2022 from 10am to 1pm – online This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your comp… Organized by Complianceonline | Type: seminae

Supplier and Contract Manufacturer Management for Medical Device Manufacturers

May 9, 2022 at 8am to May 10, 2022 at 3pm – online This 2-day virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management enabling you to provide safe and effective products to your customers.… Organized by Complianceonline | Type: seminae

Managing an Effective AML Compliance Program

May 12, 2022 at 8:30am to May 13, 2022 at 4:30pm – online Are the financial transactions within your organization subject to money laundering risk? Do you have a robust internal controls program that focuses on mitigating the greatest AML/Fraud risks? Are y… Organized by ComplianceOnline | Type: seminae
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

May 12, 2022 at 10am to May 13, 2022 at 5pm – online Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly… Organized by ComplianceOnline | Type: seminae