FDAnews Announces — Are You Ready For An FDA Manufacturing Site Inspection? Complimentary Webinar, Jan. 19, 2016

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Successfully managing an FDA inspection begins with the development of a clear company policy. A quality audit can detect program defects and, through isolation of unsatisfactory trends and correction of factors that cause defective products, prevent the production of unsafe or nonconforming devices.

Are You Ready For An FDA Manufacturing Site Inspection?
Jan. 19, 2016 — 1:30 p.m. – 2:30 p.m. EST
http://www.fdanews.com/fdamanufacturingsiteinspection

Successfully managing an FDA inspection begins with the development of a clear company policy. It requires frequent employee training so they are in a position to maintain best practices regarding day-to-day procedures. Companies also need to make sure they define the roles and responsibilities of all company employees during an inspection.

If properly conducted properly, a quality audit can detect program defects and, through isolation of unsatisfactory trends and correction of factors that cause defective products, prevent the production of unsafe or nonconforming devices. Without an effective quality audit function, the quality system is incomplete and there is no assurance the manufacturer is consistently in a state-of-control.

Inefficient manual audit procedures negatively impact operational effectiveness and can increase the risk of low product quality as a result of:

  •     Poor communication and scheduling
  •     Inconsistent audit output
  •     Lack of visibility and insight into issue trending
  •     Difficulty in ensuring resolution of corrective and preventive actions (CAPA)

During this webinar, attendees will learn practical techniques for improving audit preparation, execution and post audit activities for both internal and supplier audits. They will also gain insights on how leading companies are leveraging technology to enable end-to-end audit process automation to improve compliance, and as a result are reducing audit costs, increasing productivity, reducing operational risks and ultimately improving product quality.

Who Will Benefit:
Individuals involved in:

  •     Executive Management
  •     Quality, Compliance, and IT Managers
  •     Manufacturing Directors and Supervisors
  •     Pharmaceutical and cGMP Auditors
  •     QA/QC personnel
  •     R&D Staff
  •     Regulatory Affairs Professionals
  •     Risk Management Specialists
  •     Training Personnel
  •     Validation Specialists, Scientists, Engineers

Meet the Instructor:
Tom Middleton, Solutions Architect at Sparta Systems, has spent twenty years conducting nearly 1,000 registration, surveillance, internal and supplier audits as an ASQ / RAB Certified ISO and Global cGMP lead compliance auditor for Underwriter’s Laboratories and Bausch + Lomb’s Surgical Division. Specializing in management system audits and the development of internal and external audit programs and tools, Mr. Middleton has a passion for helping people ensure management system quality and robust compliance through value-added, process-driven auditing programs.

Webinar Details:
Are You Ready For An FDA Manufacturing Site Inspection?
Jan. 19, 2016 — 1:30 p.m. – 2:30 p.m. EST
http://www.fdanews.com/fdamanufacturingsiteinspection

Tuition:
Free

Easy Ways to Register:
Online:     http://www.fdanews.com/fdamanufacturingsiteinspection
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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