All Events in online (18)

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

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
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

Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing

September 29, 2021 at 9:30am to September 30, 2021 at 5:30pm – online The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. The FDA's findings of deficiencies concerning equipmen… Organized by Complianceonline | Type: seminae

REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

October 4, 2021 at 7am to October 5, 2021 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

Designing and Sustaining New and Existing Product Stability Testing Program

October 6, 2021 at 9am to October 7, 2021 at 4pm – online This Virtual Seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries i… Organized by Complianceonline | Type: seminae