Secrets to Writing Effective SOPs for Medical Device QMS
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Category Medical Device QMS, Quality Management System, Training Specialists, CAPA Specialists
Deadline: March 24, 2019 | Date: March 25, 2019
Venue/Country: Online, U.S.A
Updated: 2019-01-31 18:28:08 (GMT+9)
Call For Papers - CFP
OverviewStandard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed.More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.Why should you Attend"Inadequate SOP" observations still rank among the most frequently cited 483 and Warning Letter observations. SOPs are one of the first things an auditor/ investigator will review during and inspection. Most importantly, poorly written procedures make it difficult for your employees to understand and consistently follow procedures. This can lead to disastrous consequences including quality problems and even recalls. Poorly written SOPs can and do impact your business.Areas Covered in the SessionFDA Expectations for SOPsLessons Learned from 483s and Warning LettersCommon Problems and MistakesHow to Structure your QMS and SOPsHow to Outline and Format your SOPsUsing Process Maps to Make Procedures ClearUsing Diagrams and VisualsMaintaining and Controlling SOPsEnsuring Adequate Training to your SOPsBest PracticesWho Will BenefitQuality Systems SpecialistsDocument Control SpecialistsQuality and Compliance SpecialistsInternal Auditors and ManagersTraining SpecialistsCAPA SpecialistsQuality/Compliance Managers or Directors for Medical Device CompaniesGeneral Managers Wanting to learn how to Understand Quality System RequirementsSubject Matter ExpertsSpeaker ProfileSusanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.
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