GMP Investigations

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!