Excipient Manufacturers: Practical Techniques for Conducting Risk Assessment

Thursday, December 7, 2017 - 1:00pm to Friday, December 8, 2017 - 12:00pm
Location: 

IPEC-Americas Headquarters located at 3138 N. 10th Street, Arlington, Virginia 22201

Local Hotels

Schedule:

  • Thursday, 7 Dec: 1 pm – 5 pm EST (lunch not included)
    There will be an optional networking dinner Thursday December 7th and details will be discussed at the opening of the course.
  • Friday, 8 Dec: 8 am – 12 noon (continental breakfast included)

Please do not make non-refundable travel arrangements until you receive FINAL workshop confirmation by 16 November 2017.

Risk assessment is already a hot topic for excipients and becoming more important all the time. Excipient makers have not always had the same level of need or opportunity as excipient users (pharmaceutical companies) to conduct risk assessments within their manufacturing processes.

This workshop will focus on the techniques used to conduct them, such as FMEA, FTA, HACCP, HAZOP, etc.  Using plausible but fictitious case studies and exercises, participants will spend most of their classroom time developing risk assessments.

Participants will have pre-workshop reading assignments to be completed prior to the workshop which will be key to maximizing learning.

Who Should Attend

Quality, regulatory affairs, and manufacturing employees of excipient manufacturers

Training Objectives

  • Describe and demonstrate various techniques for performing excipient-focused risk assessments
  • Describe and demonstrate several methods for reducing and / or mitigating risks
  • Describe the risk assessment elements which apply to the European Falsified Medicines Directive and the difference in the approach taken by US NSF/IPEC/ANSI 363 and EXCiPACT.
  • Describe and demonstrate (if applicable) the application of risk assessment to atypical actives.
  • Describe and demonstrate (if applicable) how to audit risk assessments.

Presenter(s)

Ann Van Meter

Ann headshot

Ann Van Meter recently retired as Business Quality Leader and GMP Subject Matter Expert for Dow Pharma and Food Solutions.  She was employed by the Dow Chemical Company for 25 years.  A chemical engineer by training, Ann has held a variety of EHS and Quality Roles throughout her career.  Prior to her retirement, Ann was actively engaged as the Dow representative in the International Pharmaceutical Excipients Council.  She also served as chair of the GMP Committee and as a member of the Executive Committee.  She led the Validation Task Team and the Technically Unavoidable Particles Work Group.
 

Cancellation Policy

Must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Workshops
3138 10th street
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees (less 5% non-refundable service fee) are refundable if cancellation is received at least three weeks (21 calendar days) prior to workshop start date (less service fees). Cancellations received thereafter are non-refundable. Registrations are transferable to other company representatives if requested via mail or e-mail up to 5 business days before the workshop.

IPEC-AMERICAS IS NOT RESPONSIBLE FOR ANY TRAVEL EXPENSES OR FEES INCURRED BY PARTICIPANTS. WORKSHOPS WILL BE CONFIRMED NO LATER THAN 3 WEEKS PRIOR TO SCHEDULED START DATE.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org