CAPA Practices for FDA Regulated Industry: Practical Tips to Meet FDA's Expectations

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Comprehend the Essential Elements of the CAPA and Their Intended Purpose

FDA inspectors are trained to look for 20 specific items in 3 broad areas specific to Corrective and Preventive Actions (CAPA) during an audit of a regulated facility. Most FDA 483s and Warning Letters list inadequate CAPA practices as one of the major findings. There are several industry-wide misunderstandings about FDA’s expectations leading to either incomplete compliance or an overtly burdensome approach leading to deficiencies in former and excessive cost and labor in the latter case.

In this 90 minute session Dr. Mukesh Kumar will list practical steps to assure CAPA practices meet FDA’s expectations, and will lead to better quality control at a regulated facility. He’ll discuss some case studies to highlight the common mistakes and how to avoid them. He’ll also provide invaluable tips to create SOPs, management policies, and training methods to withstand an FDA audit.

CAPA practices are the most common non-compliance issue identified by FDA auditors. CAPA should be based on common sense and practical elements derived from risk-based analysis of procedures. Ideally, CAPA should be instinctive and a combination of retrospective and prospective quality elements. Most organizations can benefit from a review of the core expectations from FDA and an on-ground analysis of what is applicable instead to taking boiler plate process from other organizations. CAPA can have several unique site-specific elements in addition to the common industry-wide practices.

Join Dr. Kumar to discuss the regulations, FDA training processes specific to CAPA, and best practices for compliant facilities. Case studies from drugs, biologics and medical device facilities will be used to highlight common errors and acceptable solutions.

Take a look at the topics covered:

  • Requirements of the CAPA process and procedure
  • Essential elements of the CAPA file and their intended purpose
  • CAPA documentation processes including CAPA plan, SOPs, and written policies
  • Best practices for CAPA process
  • Management oversight and monitoring CAPA activities
  • Case studies on site specific issues

Who should attend?

  • Quality Managers at drug, medical device and biotech companies
  • Project managers
  • Senior management for companies developing new products for US market
  • Regulatory affairs professionals
  • People investing in FDA-regulated products intended for the US market

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
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