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01-10-2019 (Online Course)

P40099 Regulatory and Compliance Requirements For CMC Analytical Studies
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Regulatory and Compliance Requirements For CMC Analytical Studies

4-week online course starting 1 October 2019

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overview

Part of PTI’s new online biopharma/biosimilar CMC analytical series this course has been designed to provide you with regulatory and compliance clarity to ensure your analytical practices meet global requirements. Over 4 weeks you will learn what studies are needed and importantly when they must be completed, minimising any development delays of your protein products (breakthrough or biosimilar). In addition, you will gain best practice as you transition from R&D laboratory analytics to GxP requirements gaining an appreciation of the data required and the risks involved. 

 

Key Benefits of Attending

  • Discover the global regulatory requirements for CMC biologics 
  • Learn what CMC data sets are required for all protein products, including biosimilars 
  • Examine when CMC analytical studies must be conducted during development  
  • Understand the CMC timelines for biosimilar and biopharmaceutical breakthrough products  
  • Best practice for taking your R&D laboratory work to GxP standards 
  • Explore the GxP requirements for analytical CMC biologics  
  • Discover the common R&D quality and documentation issues with biopharmaceutical and biosimilar products.

Who Should Attend

This course is primarily aimed at professionals working in biopharmaceutical analytical CMC (CMC biologics). The materials are also appropriate for regulatory, project management and bioprocess professionals wanting to broaden their knowledge in CMC biologics. 

Course Duration

  • 4 weeks
  • 2 hours per week (average)

Virtual Learning

Click here: https://vle.knect365.com

pricing

Packages Price
Online AcademySGD $1000Early Bird
  • Fee stated is the discounted price PER DELEGATE.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.
  • View payment terms and bank transfer details, click here »

Trainer's Profile

Dr Nadine Ritter

Dr Nadine Ritter is President and Analytical Advisor for Global Biotech Experts, LLC. She provides expertise in analytical test method selection and optimization for product characterization, release and stability testing; analytical test method qualification and validation, as well as pre- and post- approval product comparability studies, and assay bridging/technology transfers. In addition, she routinely performs third-party laboratory quality and compliance audits for small start-ups to multinational pharmaceutical corporations and contract testing laboratories. 

Why Attend An Online Academy?

Online Academy is an excellent forum to correspond with the teacher/instructor and your fellow students within the course while saving time, cost while maximising the effectiveness of bitesize chunks-learning and regular revisions

  • Grow as a team – with multiple licenses your team can access the course and learn together, no matter where they are in the world
  • Review all content as many times within enrolment period (two month after all modules have been released)
  • Time effective – bitesize chunks so it does not impact on your normal working day
  • Progress through the course with fellow students as you would in a classroom
  • Discuss the course with fellow students
  • Cost effective – no travel expenses

About BioProcess International Academy

BioProcess International Academy is a partnership between BioProcess International (BPI) and Pharmaceutical Training International (PTI). Our vision is to accelerate the growth of the biopharmaceutical sector by providing training solutions which are designed to enhance the technical skills, knowledge and competencies of biotech professionals. The Academy’s extensive course portfolio is determined by the latest industry trends and created by our global network of leading experts and delivered via workshops, digital academies and customised onsite programs.

BioProcess International Academy’s vision is to accelerate the growth of the biopharmaceutical sector by providing training solutions which are designed to enhance the technical skills, knowledge and competencies of biotech professionals. The Academy’s extensive course portfolio is determined by the latest industry trends and created by our global network of leading experts and delivered via workshops, digital academies and customised onsite programs.


Upon completion of your BioProcess International Academy online course you will be awarded with the CPD Certification certificate. This is a recognised independent CPD accreditation compatible with global CPD principles.

The Certificate of Achievement provides proof that you have taken the course and can be used on your CV or work portfolio.

 

 

FAQ

Do sessions go out live?
No, all content is recorded and a set number of modules are released per week. You have unlimited access to module content once it has been released for the duration of the course and an additional two months.

Can I join after the course start date?
Yes, because modules are not live and all content is recorded you can catch up. Please contact us at register@ibcasia.com.sg to enquire about joining a course after the start date.

Can I still take part if I’m away for part of the course run?
Yes. Online Academies provide a flexible learning format. As modules are not released live and are available for review, you will be able to catch up.

How long is my enrolment on the course?
You are enrolled on the course for the period that modules are being released and the trainer is active on the discussion forum (this varies from course to course – between 3 – 8 weeks) and for an additional 2 months after this to review course content.

Who do I contact if I have any problems while the course is running?
You should contact BPI-online@informa.com

When will I receive my log-on details for the course?
Once you have paid, a member of the team will be in touch with your log-in details. We must receive payment for you to access the course.

How can I access the content?
Content is hosted on our Learning Management System, which you access using your device. A link will be provided to you with your log-in details.

What if I need extra time on the course?
Please contact us at register@ibcasia.com.sg if you would like extra time on your course beyond the enrolment period. Extra time is subject to approvals and fees may apply.

Agenda

Part 1 – Module 1
Regulatory Basis of CMC Analytical Requirements for Biological Products: Doing the Right Things at the Right Times

  • What are the key analytical CMC data sets required for all biotech and biosimilar products?
  • What is the critical ‘extra’ analytical data set required for biosimilar products?
  • How are these analytical data used to support biotech/biosimilar product dossiers?
  • When must these critical CMC analytical studies be conducted during product development?

Part 1 – Module 2
Regulatory Basis of CMC Analytical Requirements for Biological Products: Doing the Right Things at the Right Times

  • What are the significant challenges to the CMC timeline for biosimilar and breakthrough products?
  • What are the current Hot Button CMC analytical studies for biotech/biosimilar products?

Part 1 – Module 3
Regulatory Basis of CMC Analytical Requirements for Biological Products: Doing the Right Things at the Right Times

  • Which CMC analytical data are required to be generated in GxP vs non-GxP (eg. R&D) labs?
  • What compliance guidelines do and do not apply to analytical CMC R&D labs?
  • What are the business and regulatory risks of generating critical CMC analytical data in R&D labs?

Part 2 – Module 4
Dossier R&D Data versus GxP Data: Analytical Lab Quality Practices from R&D to GxP

  • What are current best practices for R&D labs to assure the quality, integrity and security of critical data sets?
  • How can you confirm that an R&D lab has implemented and is consistently following best quality practices?
  • What are current FDA expectations for data integrity and auditing of analytical biosimilarity studies?

Part 2 – Module 5
Dossier R&D Data versus GxP Data: Analytical Lab Quality Practices from R&D to GxP

  • What are the current Hot Button lab quality practice issues and common R&D documentation deficiencies seen for
  • biotech/biosimilar products?
  • What are the specific compliance elements of laboratory GMPs, and why are they needed?
  • What are common audit observations found during laboratory GMP inspections?

when & where

01 - 30 Oct 2019

Access the Online Course : https://vle.knect365.com

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