Specification and OOS for Pharma, Biopharma and Combination Products

  • Tanvir Mahmud
  • 28, August 2019 Wednesday
  • 10:00 AM PDT | 01:00 PM EDT (90 Min)

This webinar will provide an overview of setting and maintaining specifications for Pharmaceutical and Biotechnology derived drug products throughout its shelf-life.

Live Online Training
August 28, Wednesday 10:00 AM PDT | 01:00 PM EDT (90 Min)

$249.00
One Dial-in One Attendee
$629.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Recorded Version

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section 48 hrs after completion of Live training

Training CD / USB Drive

$399.00
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 after completion of Live training
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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Learning Objectives:

Understand the principles of Specification Settings:

  • Define Terminology: CQA, CPP, OOS, OOT, OOE, Quality Attribute, Control limits, Specifications, Release vs Shelf-Life Specifications
  • Specification settings based on Early-Stage Development or preclinical data
  • Specification settings based on preclinical and clinical data
  • Lifecycle approach to setting global specifications
  • Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities
Areas Covered in the Webinar:

Overview of following in preparation of understanding setting specifications:

  • CQA and Quality Attribute
  • CPP and Control limits
  • OOS, OOT and OOE
  • Specifications, Release vs Shelf-Life Specifications
  • Specification settings based on Early-Stage Development or preclinical data
  • Specification settings based on preclinical and clinical data
  • Lifecycle approach to setting global specifications
  • Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities
Who Will Benefit:

This training discussion seminar has been designed for quality assurance, quality control, regulatory affairs and Product development (Formulation and Analytical) personnel in the Pharmaceutical and Bio-pharmaceutical Industries.

It also addresses staff from other departments too, in so far as they are subject to EU and FDA GMP compliance.

  • Product development (Formulation and Analytical)
  • Production
  • Engineering
  • Quality Assurance
  • Quality control
  • Marketing and Sales
  • Regulatory affairs
  • Supply Chain
Instructor Profile:
Tanvir Mahmud Tanvir Mahmud

Founder and Principal, Find Your Solution

Tanvir Mahmud has more than 20 years’ experience in product development, quality and project management in regulated industries including Biogen Idec, Vertex Pharmaceuticals, Boston Scientific, and Consulting Companies. She has a master’s degree in Physical and Biochemistry and a master certification in coaching. Her professional experience relates to research and development, analytical development, formulation development, quality management, chemistry manufacturing and control, drug/device/biologics/combination product stability, training and program management.

Tanvir is a consultant and a trainer at QPS and a Founder and Principal at Find Your Solution (FYS) Consulting and Training, a company offering training and consulting in Risk Management and Continuous Quality improvement.

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. FDATrainingAlert 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@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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