Upcoming Events (22)

Change Control Best Practices - Avoiding Unintended Consequences of Changes

September 16, 2021 at 7:30am to September 17, 2021 at 1:30pm – 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

September 16, 2021 at 9am to September 17, 2021 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
Navigating through Maze of In-vitro Diagnostics

September 16, 2021 at 11am to September 17, 2021 at 6pm – online In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medic… Organized by Complianceonline | Type: seminae

Patient Communications, E-mail, and Texting - How to Meet Patient Requests for Information and Stay Within the HIPAA Rules

September 20, 2021 from 10am to 11:30am – Online event Overview: With the new HIPAA random audit program now getting under way, and increases in enforcement actions following breaches, now is the time to ensure your organization is in compliance with the… Organized by Roger Steven | Type: online, event

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

September 22, 2021 from 8am to 2pm – Online event This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent u… Organized by John Robinson | Type: online, event
Method Development and Validation for Assays Supporting Testing of Biologics

September 22, 2021 at 9:30am to September 23, 2021 at 5:30pm – online Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support develo… Organized by Complianceonline | Type: seminae

Laboratory Inspection and Auditing

September 23, 2021 from 10am to 5pm – online Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP reg… Organized by Complianceonline | Type: seminae

21 CFR Part 11, Data Integrity, and Computer System Validation

September 28, 2021 at 8:30am to September 29, 2021 at 4:30pm – online Through a wide variety of regulations, standards, and guidance, the U.S. FDA and other global regulatory competent authorities are increasingly focused on software used for numerous regulated purpose… Organized by Complianceonline | Type: seminae
HIPAA, 42 CFR Part 2, and FERPA - Rules for Managing Student Health Information

September 28, 2021 from 10am to 11:30am – Online event Overview: This session focuses on the issues of managing health information when it may that of students and may involve substance abuse treatment information. HIPAA and FERPA allow a number of discl… Organized by Roger Steven | Type: online, event
Medical Device Single Audit Program [MDSAP]

September 28, 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