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TRAINER: Change Control & Program Management Virtual Training Event
May 25, 2021 @ 8:00 am - 5:00 pm
Effective change management is a critical component in your Quality System. A robust program should ensure procedures are justified, reviewed and approved by your quality unit. This seminar outlines the steps needed to build an effective program from the ground up. Top issues such as; implementing a risk-based approach, training personnel, identifying risks, monitoring effectiveness and creating checklists are discussed. Hear industry’s best SME’s outline how to build, implement and maintain a best-in-class program.
Top Reasons to Attend:
- Learn how to build a program from the ground up
- Know the regulations and understand the drivers of change
- Develop infrastructure and budget to manage changes
- Understand the difference between low/no impact changes and everything else
- Use risk management in change control processes
- Use a risk-based approach in defining User Requirements
- Develop clear roles and responsibilities
- Conduct and master change control impact assessments
- Determine departments required to perform assessments
- Develop an assessment checklist for each department perspective
- Corrective action – Learn from mistakes of poor assessments
- Overcome the top challenges that impact the Quality Systems
- Implement a continuous improvement model
- Establish a trending program to avoid unintended changes
Personnel in the Following Environments Should Attend:
- Document Management
- Change Control
- Commissioning and Qualification
- Regulatory Affairs
Parsa Famili, MSc
President & CEO, NOVATEK INTERNATIONAL
Parsa Famili, Is the President and CEO of Novatek International. Prior to joining Novatek, he held senior management positions in quality departments of several North American pharmaceutical companies. He has participated and successfully completed several FDA, EMEA, TGA, and Health Canada audits. He was also an instructor of Chemistry and Biochemistry at Vanier College in Montreal, Quebec Canada. Mr. Famili has published chapters and articles in various industry journals and publications. His latest contribution “User Requirements & Implementation of a Risk-Based, Compliant Stability Management System” in Methods for Stability Testing of Pharmaceuticals (edited by Edited by Bajaj, Sanjay, Singh, Saranjit, 2018). He is also an international speaker for ISPE, PDA, IVT, IPA, KENX, EXPOFARMA among many other global associations.
Alan M Golden
Principal, Design Quality Consultants
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations. Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.
Dawn Marshall (Tavalsky)
Senior Director Global Quality, Sanofi Pasteur
Ms. Marshall (Tavalsky) is a Senior Director of Global Quality with Sanofi Pasteur, the vaccine division of Sanofi. She has over 30 years of experience in the pharmaceutical industry including small molecule, device, biologics and vaccines. She is a global Cleaning Validation subject matter expert, as well as a Sterility Assurance subject matter expert.