Effective Deviation Investigators Under GMP

This 120 minute training course will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

Why Should You Attend:

Observations involving deficient investigations and CAPA systems repeatedly rank among the top three to five observations noted by FDA during inspections, year over year. Failure to perform effective investigations violates GMP requirements, puts patients at potential risk and results in regulatory risk exposure that is preventable. Knowing how to approach deviation investigations in GMP effectively not only minimizes compliance risk, it constitutes sound quality management practice and can reduce the recurrence of problems that can lead to batch rejections and financial losses.

Who Will Benefit:

• Quality Assurance professionals
• Manufacturing professionals
• Laboratory managers and analysts
• Regulatory Affairs professionals

Instructor Profile: 

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC.

His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/effective-deviation-investigators-under-gmp-webinar-training-704974-prdw?channel=sciencedz