Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

Why Should You Attend:

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA continues to find fault with investigations and the stated conclusions. The FDA clearly expects that deviation investigations determine what happened, why it happened, and what was done to prevent it from happening again. Investigations also receive detailed scrutiny during FDA inspections. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to negative 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required.

Most companies develop deviation investigation systems and SOPs to meet regulatory requirements and expectations. However, having good systems and procedures is not enough. It is the content and conclusions of the investigations themselves that truly count. Arriving at correct content and conclusions relies on good investigative technique, including interviews, fact/evidence gathering, and proper determination of root cause and CAPA. Therefore, it is important that investigators conduct each and every investigation in the same manner, and to the same standards. It is truly about “How You Do the Hows” day in and day out.

This webinar will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations, product containment considerations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills and avoidance of investigation bias will also be discussed.

Areas Covered in the Webinar:

• Overview of Regulatory Requirements for Investigations
• What is a Deviation?
• Types of Deviations/Identification of Deviations
• Deviation Investigation Process Model
• Immediate Containment/Immediate Impact
• Conducting the Investigation/Investigation Principles
• Interviews
• Source Documents/Evidence
• Determining Root Cause and CAPA
• Key Elements of the Investigation Report

Who Will Benefit:

• Deviation investigators
• Reviewers and approvers of deviation investigations (e.g. Dept. Heads, Quality Assurance)
• QA staff and management
• Regulatory Affairs staff and management
• QC staff and management
• Compliance auditors

Andrew Campbell
Pharmaceutical Consultant, Quality & Compliance

Andrew Campbell, has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of Deviation-CAPA, Change Control, GMP Auditing, GMP Training, and Regulatory Inspection Preparation & Management.

Working with large and small companies, Mr. Campbell has successfully developed, remediated and implemented key Quality Systems. He is a skilled GMP Auditor, and has audited multiple API, Drug Product, Packaging, Testing and Distribution facilities. Mr. Campbell is an experienced GMP Trainer, and has developed customized and interactive training presentations for many companies. He has also provided FDA inspection support for several clients, including readiness training, on-site assistance during inspections, and authoring of written responses to inspectional observations.

Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as Director of Quality Systems.

Topic Background:

21 CFR 211.192 requires that “Any unexplained discrepancy (or the failure of a batch or any of its components to meet any of its specifications) shall be thoroughly investigated, whether or not the batch has already been distributed.” Therefore, it is critically important for companies to perform and document deviation investigations in accordance with the regulatory requirements. Investigations must be thorough, fact-based, and assure ongoing compliance of GMP operations.

Follow us :