Description Cleanroom Training – Preparing for Your cGMP Audit - One (1) Day Class – Thursday November 7, 2019 - CTC-PGMP-1 Presenters: Joe Winslow, JW Consulting Engineers and Celeste O'Connor, Quality Assurance Executive The scope of this presentation covers drug and biological product regulatory inspections (audits). The regulatory focus of this presentation will be FDA regulations. This class is a great introduction to prepare for an FDA inspection and is designed to give a solid foundation of knowledge. We will review industry terminology, the purpose and history of FDA, and will cover the standard requirements for the quality system. Material, Quality, Laboratory, Facilities, Manufacturing, and Packaging are the six systems, and will be discussed in the class. Presentations include the six quality system elements and how they interact to protect the end patient. The important elements of audit preparation, execution and follow-up will be outlined and covered in this class. The class will review regulatory expectations and communications with the agency. This training class is hands on and includes an interactive audit exercise. Professionals in many industries including pharmaceutical production, Biotech production, medical device, and other applications should take this class for an introduction into GMP audits. This class is great for manufacturing, facilities, quality assurance, quality control, and materials management groups to develop a basic understanding of GMP inspections. Preparing your audit team• Prepare tour• Preparing for Opening Meeting• Preparing for Closing Meeting• What is a “war room” and why you need one• What to say• What not to say• How to conduct personal behaviorSite Presentation• Systems and utility validations• Monitoring results of environmental controlsQuality Management System• SOPs, Work Instructions• Change control• Failures/OOS Investigations• CAPA• Complaints• Risk managementManufacturing Processes• Equipment/Cleaning validations• Production/Process controls• Vendor qualifications And more…. Product Code: CTC-PGMP-1 GMP Training, Preparing for Your cGMP Audit, One (1) Day Class, Thursday November 7, 2019 For more options, visit our main Cleanroom Training section. TO ENROLL IN “Preparing for Your cGMP Audit” ONE DAY TRAINING To enroll in “Preparing for Your cGMP Audit” one day training, you can click above, call customer service at (303) 752-0076, or email firstname.lastname@example.org. Registration deadline is 14 days prior to class date, class size is limited. Registrant cancellation notices received 60 days or more before the scheduled class will receive a 100% refund, less a $100.00 administration fee. Registrant cancellation notices received 30-59 days before the scheduled class will receive 50% refund. No refunds will be issued for cancellation notices received less than 30 days before the scheduled class. CRW reserves the right to reschedule any class which does not meet minumum enrollment requirements. In this case, registrants will receive 100% refund. Please see Class Outlines and Schedule for more training courses.