Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Join us as we take a deep dive into critical areas of pharmaceutical manufacturing at the ISPE Bethesda Training Facility located at 6110 Executive Blvd, Suite 600, North Bethesda, MD 20852.
This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities.
Cheryl Bondurant, a Compliance Consultant at CAI is a professional with 38 years of experience working in FDA and ISO regulated environments. She has implemented effective compliant quality systems for medical devices, biologics, in-vitro diagnostics and electronics. Cheryl is an instructor of FDA regulations and ISO standards and implementation for Quality Systems for Medical Devices and Current Good Manufacturing Practices for Finished Pharmaceuticals.
This GAMP Data Integrity 21 CFR Part 11 Classroom Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.
Winnie Cappucci retired from the position of Associate Director Product Supply IT Systems Compliance, North America for Bayer HealthCare. She has worked in the pharmaceutical industry for 43 years and in global roles for the last 19 years. Ms. Cappucci has worked as a business process owner, an IT professional and lastly as a quality and compliance specialist in a highly regulated environment
This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins.
Robert Warn is a Senior project manager and Principal Engineer at Commissioning Agents Inc., with over 14 years in the biotechnology industry. He has extensive project management, process engineering, commissioning, qualification and process validation experience on biotechnology manufacturing systems and equipment. His expertise are focused on process tech-transfer and manufacturing equipment implementation.
This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.
Rebecca Brewer has more than 29 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries. She began work with Quality Executive Partners, a boutique consultancy to make a difference in pharmaceutical consulting in 2013. Becky is the current instructor for ISPE’s Cleaning Validation Educational course and PDA’s Biotechnology Cleaning Validation course. She also frequently conducts site-specific validation and GMP compliance training for individual companies.