Implementing effective CAPA systems - one 483 avoidance strategy

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"Listen From Charles H Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years"

CAPA systems and 483 avoidance strategy

Description

How CAPA’s are executed and managed is crucial to maintaining a compliant organization. Inadequate CAPA processes continue to be a major GMP deficiency and consistently make the FDA’s top five list for adverse observations. The primary objective of this webinar is to heighten awareness of the importance of the proper execution of the CAPA process to the organization, to the efficacy of the product and to the safety of patients and customers, and to describe the structure and function of an effective CAPA system.   t is always about success not failures…right?   But in the life sciences we must address failures as well.   Complaints and product issues must be handled expeditiously according to regulation or we will suffer the wrath of the FDA.   

Regulatory audits and FDA 483 regulatory observations are the two events that are a constant worry for managers in regulatory industries.  In terms of the FDA, from 2012 to 2016, the FDA has increased the number of warning letters issued by over 1200%.  This is the primary reason that understanding CAPA and having a comprehensive CAPA system is critical to maintaining regulatory compliance.  

A CAPA system can help to identify problems before they become critical, can go a long way in the development of positive relationships with regulatory agencies by instilling confidence in your company’s ability to identify and solve problems quickly and effectively, and further that confidence by convincing regulatory bodies and clients that identified problems have been resolved. 

Following the guidance provided in this webinar will help to reduce nonconformance to procedures, improve the quality of the work that you do, and significantly minimize customer complaints.

Why should you attend :

It is always about success not failures…right?   But in the life sciences we must address failures as well.   Complaints and product issues must be handled expeditiously according to regulation or we will suffer the wrath of the FDA.   

Regulatory audits and FDA 483 regulatory observations are the two events that are a constant worry for managers in regulatory industries.  In terms of the FDA, from 2012 to 2016, the FDA has increased the number of warning letters issued by over 1200%.  This is the primary reason that understanding CAPA and having a comprehensive CAPA system is critical to maintaining regulatory compliance.  

A CAPA system can help to identify problems before they become critical, can go a long way in the development of positive relationships with regulatory agencies by instilling confidence in your company’s ability to identify and solve problems quickly and effectively, and further that confidence by convincing regulatory bodies and clients that identified problems have been resolved. 

Following the guidance provided in this webinar will help to reduce nonconformance to procedures, improve the quality of the work that you do, and significantly minimize customer complaints.

Areas Covered

At the completion of this webinar participants will be able to:

•         Define the term CAPA 
•         Explain why effective CAPA systems are important to any regulated life science business
•         List and describe the relevant CAPA regulations
•         Explain the concept of exception/deviation reporting
•         Describe the CAPA process flow
•         Explain in detail each CAPA process step
•         Identify the challenges and pitfalls of CAPA
•         Explain the relationship between CAPA and risk mitigation
•         Explain how Root Cause analysis is conducted

Who will Benefit

Staff within all functions within the organization to include Quality and Regulatory functions that are responsible for interacting, initiating, managing, or investigating CAPA’s.  The specific titles that would apply are indicated below and would relate to logistics/supply chain, procurement, operations, manufacturing, quality, compliance, and technical assurance.

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Charles H Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues. 

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military. 

He has dedicated his entire professional career explaining the benefits of performance-based training

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