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GMP Investigations - online live webinar on November 2017 by Training Doyens. Training Class and Courses. This GMP compliance webinar will discuss the keys to an effective cGMP investigation and the root cause determination and CAPA effectiveness checks.

Webinar Information


GMP Investigations


Webinar Title
GMP Investigations
Event Type
Webinar
Webinar Date
15-11-2017
Last Date for Applying
15-11-2017
Location
Denver, Colorado, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Training Doyens
Organization Type
Organization/Company
Webinar Category
Both (Technical & Non Technical)
Webinar Level
All (State/Province/Region, National & International)
Related Industries

Medical/Healthcare/Hospital

Registration/Ticket Booking Address
Location
Denver, Colorado, United States
Get In Touch

OVERVIEW

This webinar will concentrate on the key attributes of an effective cGMP investigation, the role of management, quality control tools, CAPA effectiveness and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Inadequate investigations”

“Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated. A written record of the investigation shall be made and shall include the conclusions and follow-up.”

  • 21CFR Part 211.192.

Implementing an effective system of conducting investigations that, ensure compliance of the five manufacturing systems: production, facilities and equipment, laboratory controls, materials, packaging and labeling and the overarching quality system is a critical requirement for the manufacture and sale of all FDA regulated products.

WHY SHOULD YOU ATTEND

Any FDA inspection will ask to review your complaints, investigations and recalls. This, with a tour will be their first impression of your organization’s state of compliance. The investigations you performed for unexplained discrepancies and complaints will need to stand alone for an inspector to read and understand. They can and will ask questions for clarification but minimizing the number will not sidetrack their focus.

In a list of top ten reasons for FDA form 483s, investigations discrepancies, failures were number two.

Effective and repeatable failure investigation and root cause analysis is still not the industry norm.

This webinar will discuss the keys to an effective cGMP investigation, the role of management, employing quality tools, root cause determination and CAPA effectiveness checks.

Unexplained discrepancies and failures will occur; effective investigations and CAPAs ensure they do not reoccur.

AREAS COVERED

This webinar will give you a process to establish an effective system of conducting investigations. This includes:

  • Why an investigation?
  • What is an effective investigation system?
  • 21CFR Part 211.192 Requirements
  • Steps to follow to conduct a thorough investigation.
  • Root Cause versus symptoms of an unexplained discrepancy
  • Methods to determine root cause
  • Historical review’s role in investigations
  • CAPA’s role in investigations
  • Creating a culture of compliance in your organization

WHO WILL BENEFIT

  • Site Leaders/Plant Managers
  • Directors of Quality and Manufacturing
  • Manufacturing Supervisors and Managers
  • QA, QC Supervisors and Managers
  • Maintenance Supervisors and Managers
  • Laboratory Managers and Supervisors
  • Quality Assurance/ Quality Control Personnel
  • Document Control Personnel
  • Quality Auditors

LEARNING OBJECTIVES

  • The benchmarks and best practices for writing thorough and compliant investigations.
  • How to determine your organization’s current investigation effectiveness.
  • Provide a template that will enable managers and supervisors to write effective investigations.
  • Timeliness – How to meet both the compliance and customer impact to your organization
  • The Investigation/CAPA challenges affecting organizations and how to address them

Others Details

This GMP compliance webinar will discuss the keys to an effective cGMP investigation and the root cause determination and CAPA effectiveness checks. Book now!

Registration Fees
Available
Registration Fees Details
Live Session for one participant $199 Corporate Live Session Group – Max 10 Participants from one location. $549 Recorded Session Get unlimited access to audio recording of the webinar for 6 months. $219 Training CD MP3 files, PDF presentation and reference manual will be delivered on a CD $399 Super Combo Offer 1 Live and Recorded webinar $329 Super Combo Offer 2 Live and Training CD $499
Registration Ways
Email
Phone
Website
Other
Registration/Ticket Booking Address
Address/Venue
26468 E Walker Dr, Aurora, Colorado 80016-6104  Pin/Zip Code : 80016
Official Email ID
support@trainingdoyens.com
Contact
Training Doyens

26468 E Walker Dr, Aurora, Colorado 80016-6104

support@trainingdoyens.com

   7209961616
Training Doyens

26468 E Walker Dr, Aurora, Colorado 80016-6104

support@trainingdoyens.com

   7209961616      7209961616
   Fax No: Colorado City
Get In Touch