MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

Major CGMP Issues - US FDA Concerns in 2022

Event Details

Major CGMP Issues - US FDA Concerns in 2022

Time: May 31, 2022 from 10am to 1pm
Location: online
Street: Compliance Online
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Phone: 8887172436
Event Type: seminae
Organized By: Complianceonline
Latest Activity: Apr 23, 2022

Export to Outlook or iCal (.ics)

Event Description

This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.

Why Should You Attend:

A review of recent US FDA Inspectional Observations / FDA Form 483 Observations, as well as FDA statements and actions, indicate the major areas of regulatory concern. The past is no indicator of present or future concerns. The Agency uses publicized high-profile cases to drive compliance in the regulated industries. Certain CGMP areas, e.g., CAPA, are receiving increased scrutiny. "Risk-based" (patient risk) is another. Failure to correct problems leads to Warning Letters or more severe regulatory actions. Requirement for "better science" must be evident in compliance. "Business as usual" is never acceptable, but do some of a company’s documents reflect that outdated thinking. Also changes from the EU, MDD to MDR, ISO 13485:2016 ... confusion over what is "Risk". Don't be caught off guard by these major shifts in emphasis. Refine internal audits and get your company prepared to address the FDA's most recent requirements both in the US and outside.

This tougher emphasis also affects clinical trial expectations, product submissions and company response requirements. This change has a major impact on individual compliance objectives, efforts and measurements of success. The definition of "Risk" in systems and documentation can make the difference in a "Pass" or "Fail" regulatory inspection.

Areas Covered in the Webinar:

  • Recent industry trends, bad and good
  • The FDA’s Strategic Priorities
  • Major foreseeable problem areas for 2022 onward - The "Heavy Hitters"
  • A company gap analysis
  • Correcting problem-prone areas
  • Avoid complacency from past “good” audits

Who Will Benefit:

  • Senior Management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering

Comment Wall

Comment

RSVP for Major CGMP Issues - US FDA Concerns in 2022 to add comments!

Join MedTech I.Q.

Attending (1)

© 2024   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service