ComplianceOnline

Safety Risk Management for the Pharmaceutical Industry

Instructor: Edwin L Bills
Product ID: 700728
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2008

Training CD / USB Drive

$500.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This program will be helpful for those who must develop Risk Management processes for Pharmaceutical companies.

Description

This seminar will discuss how to make Risk Management an integral part of the processes of process design and manufacturing for the industry.

The Pharmaceutical Industry is working to implement Safety Risk Management using ICH Q9 Guidance along with ICH Q10 Guidance on Quality Management Systems and ICH Q8 on Pharmaceutical Development. This seminar will discuss how to make Risk Management an integral part of the processes of process design and manufacturing for the industry. By planning for and reducing risk the industry will reduce time to market and reduce the cost and regulatory burden of changes in the future.

Areas Covered in the seminar:

  • Defining the terminology of Risk Management.
  • Integrating Safety Risk Management in the Pharmaceutical Quality Management System.
  • Reducing Risk in pharmaceutical manufacturing processes.
  • Including Risk Review in the complaint-handling and CAPA processes.

Who will benefit:

This program will be helpful for those who must develop Risk Management processes for Pharmaceutical companies, including:

  • Manufacturing engineers
  • Process engineers
  • Quality engineers
  • Complaint personnel
  • Company clinical
  • Regulatory personnel

Instructor Profile:

Edwin L. Bills, was Industry Co-chair for the AAMI Committee AAMI/QM/WG 04 Application of risk management to medical devices, representing the United States on ISO TC 210 Joint Working Group 1 which developed the ISO 14971 standard. He has served as a Director of Risk Management for major medical device companies. Mr. Bills also presented at a number of conferences on Risk Management topics and has authored articles on the topic as well.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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