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    Webinar On How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

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    Website https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1459 | Want to Edit it Edit Freely

    Category Food, Drugs & Biologics

    Deadline: October 13, 2015 | Date: October 13, 2015

    Venue/Country: Mississauga, Canada

    Updated: 2015-09-24 21:01:51 (GMT+9)

    Call For Papers - CFP

    Description :

    FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. In addition, using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.

    For easy implementation, attendees will receive three SOPs

    Checklist: Part 11 compliance

    Case Studies: How to avoid Part 11 related 483's and Warning Letters

    SOP: Electronic Audit trail: Specifications, Implementation, Validation

    Areas Covered in the Session :

    FDA's current inspection and enforcement practices

    FDA's new interpretation: learning from FDA inspection reports

    Strategy for cost-effective implementation of Part 11: A six step plan

    Recommended changes to existing Part 11 programs to reduce costs

    Justification and documentation for the FDA and your management

    Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.

    Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.

    How to prepare your company for Part 11 Inspections

    Who Will Benefit:

    A must attend webinar for professionals in Small, midsize and large Pharmaceutical companies, API manufacturers, Contract laboratories, Clinical testing laboratories, CROs, Medical device industry. The professionals who will benefit include all:

    QC managers

    QA managers and personnel

    IT administrators

    Analysts

    Regulatory affairs

    Training departments

    Documentation department

    Consultants


    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.