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    Secrets to Writing Effective SOPs for Medical Device QMS

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    Website www.traininng.com/webinar/secrets-to-writing-effective-sops-for-medical-device-qms-200666live?ourglo | Want to Edit it Edit Freely

    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

    Overview

    Standard 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 Session

    FDA Expectations for SOPs

    Lessons Learned from 483s and Warning Letters

    Common Problems and Mistakes

    How to Structure your QMS and SOPs

    How to Outline and Format your SOPs

    Using Process Maps to Make Procedures Clear

    Using Diagrams and Visuals

    Maintaining and Controlling SOPs

    Ensuring Adequate Training to your SOPs

    Best Practices

    Who Will Benefit

    Quality Systems Specialists

    Document Control Specialists

    Quality and Compliance Specialists

    Internal Auditors and Managers

    Training Specialists

    CAPA Specialists

    Quality/Compliance Managers or Directors for Medical Device Companies

    General Managers Wanting to learn how to Understand Quality System Requirements

    Subject Matter Experts

    Speaker Profile

    Susanne 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.


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.