Why Should You Attend:
When unexpected events happen—you cannot follow an SOP and need to deviate from it, or you obtain an out-of-specific action test result, or your supplier’s raw materials marginally fail specific action and you desperately need the material—what do you do? A few years ago, the standard reaction to an unexpected event was to ignore it or make an attempt to quickly fix it. Today, such reactions are unacceptable when working in a GMP environment. FDA’s strategy for GMP implementation for the 21st century—part of its quality systems approach—demand that proper investigations and corrective actions take place and be documented. Not only do you need to investigate the event to determine what happened, but you need to find out why the event happened and resolve it in a manner that prevents recurrence. It’s sound GMP, and makes good business and economic sense. A well-managed CAPA (corrective and preventive action) program not only provides effective and mandated regulatory compliance, but also yields enhanced productivity.
As part of FDA’s “GMPs for the 21st century” program, performing effective investigations into deviations and failures has become a key element of risk management and GMP improvement, and has become a key focus during regulatory inspections.This course teaches tools and techniques that can be employed to get to the root causes of unexpected quality events, and help resolve them in a lasting, GMP compliant manner.
Areas Covered in the Webinar:
At the end of the course you will:
Who Will Benefit:
Danielle DeLucy, MS, is the owner of ASA Training and Consulting, LLC, providing pharmaceutical and biologics-based companies with training and quality systems assistance in order to meet regulatory compliance. Danielle has been in the industry for over 15 years, serving in numerous quality management roles, such as the Director of Product Quality, where she oversaw sterility assurance practices and provided QA oversight of numerous filling and packaging operations.
Danielle began her career as a Quality Control Pharmaceutical Microbiologist, performing various tests for laboratory clients. She’s continued in the quality management arena while increasing her responsibility. She has helped to lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection.
Currently, Danielle assists companies facing warning letters and consent decrees as well as those wishing to improve GxP practices and establish more robust quality systems.
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
PAYMENT METHOD: 100% Secure Transaction