Implementing a Change Control Quality System Successfully – Webcast On-Demand
In this 53-minute webcast, Danielle DeLucy, Subject Matter Expert in the areas of quality assurance and quality systems, provides proven success steps, tips and recommendations for implementing a change control quality system successfully.
What You Will Receive includes
- Webcast audio/video presentation
- 47-slide Powerpoint presentation
Why You Should Attend
- Change Control is a Regulatory Requirement:
- “…..change control measures can apply to equipment, standard operating procedures, manufacturing instructions, environmental conditions, or any other aspects of the process system that has an effect on its state of control, and therefore on the state of validation.” – Proposed Rules, 21 CFR parts210 and 211 – May 3, 1996
- Proper Documentation – In Subpart F, section 211.100(a)
- “There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control
Areas Covered in the Webcast
- Why Change Control?
- Types of changes subject to change control:
- Elements of a change control
- Change Assessment Risk and Execution
- Documentation Systems
- And More…
Who Will Benefit
Industry professionals from many areas who may interact directly with regulatory inspectors or who help prepare for inspections, including:
- Quality Assurance/Quality Control
- Technical Operations
For Customer Care and Group Discounts – Please Contact Us
Phone: (+1) 844.686.5750
Danielle DeLucy is an industry veteran and specializes in the areas of Quality Assurance and Quality Systems as a consultant. Prior to this role, Danielle has been in the industry for 15 years serving in numerous quality management roles, such as the Director of Product Quality with oversight of sterility assurance practices and numerous filling and packaging operations. Danielle began her career as a Quality Control pharmaceutical microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena with increasing 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 who: 1) are faced with warning letters and consent decrees; 2) wish to improve GxP practices; and 3) need to establish more robust quality systems.
Registrants may cancel up to two working days prior to an on-line course or webinar start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. On-site training can be cancelled up to ten business days prior to training. Windshire will be compensated for any travel cancellation fees. Courses and webinars may be cancelled due to unavoidable factors. Registrants will be notified if a cancellation occurs. Attendees can choose between the recorded (on-demand) version of the webinar or a full refund for any Windshire cancelled webcast.
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