Turning Failure into Success - FDA Ready Deviation Investigations
- Wednesday
- November
- 06
- 2024
Steve Greer Overview:
Quality deviations create significant lost time, money, risk and possibly negative impacts on patient health. Many organizations see investigation of deviations as a necessary evil or the janitorial work of Quality Assurance. This webinar focuses on how to reframe investigations to help your organization thrive. We will cover keys to success in how to organize, execute, and follow-up on quality deviations leveraging insights from FDA and industry experts gained through real-world experience and numerous industry-FDA interactions. This is a practical webinar covering actionable takeaways to help you succeed.
Why should you Attend:
Another quality issue, one more lot on hold that won’t be released anytime soon, more time required to investigate a quality system failure, an avalanche of CAPAs that are overdue, Not to mention more risk during the next FDA inspection when all your investigations are scrutinized. What is the path forward? How can you turn failure into success not just for the FDA but for your patients, your site, and your business?
Learn how to strengthen your quality deviation investigation system and create a quality culture that sets you up for success. Become a champion of change in your organization delivering improved business results across the board not just during your next FDA inspection.
Areas Covered in the Session:
- Common challenges in quality deviation investigations
- How to organize for success
- Best practices in conducting investigations
- Tips for writing solid investigation reports
- Developing an evaluation process for the quality of investigations
- Keys for CAPAs that set you up to win
- Creating a quality culture that wins with failures
Who Will Benefit:
- Operations/Manufacturing
- Plant Engineering
- QA/QC Leaders and Staff
- Process Excellence/Improvement leaders
- Compliance Officers and Auditors
- Deviation Investigators
Speaker Profile
Steve Greer is a consultant, business owner, speaker, and leadership coach. Steve spent over 35 years with Procter & Gamble where he held numerous leadership positions in quality assurance and manufacturing across P&Gs pharmaceutical, OTC, and cosmetic businesses. Prior to finishing his career at P&G, he led external engagement and regulatory intelligence working with FDA and pharma/OTC/cosmetic industry associations. During his career, Steve was a QA Director and successfully led the remediation efforts of two businesses with Warning Letters and hosted numerous regulatory inspections. He served as an internal consultant and trainer which prepared him for consulting across the pharma, OTC, and cosmetic industries. In 2017, he was awarded the James N. Gamble Award, the highest recognition to individuals in Quality Assurance who have made outstanding leadership contributions.
Steve often speaks at pharma conferences on GMP and leadership topics and leads workshops to build quality and GMP capability. Steve has served on the core team of the ISPE Advancing Pharmaceutical Quality initiative and co-led the development of the APQ Management Review & Responsibilities guide. He also served as co-chair of the Quality Assurance Committee of the Personal Care Products Council for many years and as the chairman of the Pharmaceutical Industry Association of Puerto Rico’s QA committee. Steve has been an industry leader working closely with FDA on the Quality Metrics and Quality Management Maturity initiatives.
Outside the GMP world, Steve and his wife also lead Genesis Counseling Center with offices based in Virginia and Texas where they serve thousands of clients of all ages from multiple locations, Genesis Autism Center providing compassionate ABA therapy for children with autism, and Genesis Assist which provides GMP consulting, leadership coaching, keynote speaking, and helps counseling practices grow through consulting, medical billing, and insurance credentialing.