Category: Innovation

Developing ANDA Para II and III Drug Products via QbD (Quality by Design) : Innovation Management Case Study

8/7/2019

developing ANDA para II and III drug products via Quality_by_design an innovation management case study

QbD, Innovation Management and Training Case Study

Problem: A multi-national bio-pharma company wanted to develop Three new products via QbD methodology for US (ANDA para II and III) and Canada markets. Their employees weren’t trained in QbD methodology, hence needed both direction for product development as well as training in QbD.

Due Diligence: A due diligence of product development work conducted so far, machinery, manufacturing site, testing equipment etc. was conducted. A report comprising the QbD design thru implementation strategies and training programs was presented to the company’s management.

Solution: Appropriate training on QbD was given to the organization’s scientific team in R&D and operations. Training was provided as classroom coaching as well as online courses.

In addition to QbD implementation at design and development phase, a Risk Assessment protocol was developed for procurement of drugs and critical excipients, such that, the company can have the flexibility to choose vendors as needed.

Results Dashboard:

All 3 product were developed with QbD compliance and launched on time.
Additionally, QbD implementation reduced 10% cost on product analysis in its very first year of implementation.

To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

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Keywords and Tags:
#ContinuousImprovement #Innovation #QbD

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Popular Workshops & Webinars on 'Continuous Improvement' for Research and Product Development

2/9/2019

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Shorten Product Development Times, Error-Proof Products & Services, Build Quality-by-Design and Increase R&D Productivity with Lean, Kaizen, Six Sigma and Other Continuous Improvement Methodologies

Some of the Popular Continuous Improvement Workshops & Webinars Conducted by Dr. Shruti Bhat to Increase R&D Efficiency -

Lean Innovation workshop by Dr Shruti Bhat

Mistake-proofing with FMEA and Poka Yoke, workshop by Dr Shruti Bhat

building capability and culture for innovation in your organization workshop by dr shruti bhat

design thinking masterclass by Dr Shruti Bhat

product development via quality by design workshop by Dr Shruti Bhat,

DFSS and Hoshin Kanrii for innovation and product development workshop by Dr Shruti Bhat

kaizen masterclass for manufacturing and service industries by shruti bhat

Continuous improvement tools for manufacturing and service industries workshop by Dr Shruti Bhat

About Shruti Bhat PhD, MBA, Certified Lean Six Sigma Black Belt

Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

Follow Shruti on Twitter, YouTube, LinkedIn

Keywords and Tags:
#ContinuousImprovement #QualityImprovement #LeanInnovation #LeanManagement #KaizenMasterclass

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Kaizen Orientation Training

11/18/2018

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Glad to be invited as Course Director and Instructor for Kaizen Courses at Kaizen Leader Academy, Canada
Here are details of fourth course of the series...

Kaizen orientation online workshop by Dr Shruti Bhat

Kaizen Orientation Training Online Workshop is for Professionals at all levels of Management.

Get answers to everything you wanted to know about Kaizen continuous improvement.
Learn in-depth about 9 types of Kaizen viz. Gemba Kaizen, Lean Kaizen, Modular Kaizen, Blitz Kaizen, Flow Kaizen, Process Kaizen, Personal Kaizen, Daily Kaizen, Agile Kaizen and how each Kaizen type can help you achieve success with your Kaizen initiatives.

The workshop has 2 Modules of self-paced study, training videos and instructor support. The workshop also includes 3 Case Studies of successful Kaizen implementation.

Participants must complete Tests (open-book exam) associated with each study module; successful participants get a Certificate of Completion- Kaizen Orientation online workshop.

After successful completion of the workshop, participants gain the knowledge to apply Kaizen in their organization.

#Kaizen

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Kaizen Champion Certification Online Course

11/15/2018

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Glad to be invited as Course Director and Instructor for Kaizen Courses at Kaizen Leader Academy, Canada
Here are details of third course of the series...

Kaizen Champion Certification

kaizen champion certification online course, kaizen training

Kaizen Champion Certification Online Course is for Professionals at all levels of Management.

Learn how to select Kaizen projects, strategize, design and implement Kaizen continuous improvement campaigns.
Lean how to drive Kaizen projects successfully, create profits, reduce defects- overheads- errors, increase productivity- sales-market share- customer satisfaction. Take your company and career to the next level!
Learn in-depth about 9 types of Kaizen viz. Gemba Kaizen, Lean Kaizen, Modular Kaizen, Blitz Kaizen, Flow Kaizen, Process Kaizen, Personal Kaizen, Daily Kaizen, Agile Kaizen and how each Kaizen type can help you achieve success with your Kaizen initiatives.
The course has 6 Modules of self-paced study, training videos and instructor support, a Toolkit comprising 52 tools and 5 Case Studies that help you apply Kaizen to your organization.
The course includes videos showing real-time application of Kaizen in 5 reputed companies in US and Japan.

Participants must complete Tests and Assignments associated with each Module. All tests and assignments are open book exams. Kaizen Champion Certificate shall be sent to participants once they complete all tests and assignments successfully.

After successful completion of the course, participants gain the vision, knowledge and capacity to drive Kaizen implementation in their organization.

#Kaizen #KaizenChampion #KaizenCertification

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8 Steps to Becoming a Customer- Centric Organization.

7/5/2017

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Customer-centric approach comprises of sequential and collaborative efforts at understanding the voice of the customer (VoC).

8 steps to becoming a customer_centric organization

www.Innoworks.ca

There is only one valid definition of a business purpose: to create a customer
- Peter Drucker

Customer-centric approach comprises of:

Customer insights.
Customer focus.
Customer solutions.
Customer management.
Customer process.
Customer contact.
Customer loyalty.

In order to understand the customer, the surest and most efficient approach is to take the basic concept of business process mapping and re-modelling it in a certain way that provides a dedicated focus on the customer. This process is defined as “Customer mapping”.

The information arising out of customer mapping helps the company to improve or redesign its internal business processes that lead to the making of its product (or services).

Customer mapping allows a company to focus on the actions a customer must take in order to purchase its product (or services). That is, customer mapping provides the company with a complete overview of its customer’s journey. The company can then evaluate and devise ways to determine what it can do to enhance the perceived value of its goods (i.e. product or services).

The customer map also helps identify unnecessary actions a customer must take to buy its product, as well as redundancies, wasted time and rework that diversely affect the customer’s buying behavior.

Following 8 steps facilitate to become a Customer- Centric organization-

Define your target customers.
Learn how customers feel and perceive your company.
Align technology, process, products and services to customer needs.
Map and improve customer journey.
Engage leadership and staff in the customer mapping activity.
Transform your organizational culture and reward systems.
Measure your performance using customer centric KPIs.
Incorporate customer feedback into process and product (or services) innovation and design.

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#ContinuousImprovement #Innovation #BusinessProcessManagement #LeanInnovation #BPM #LeanManagement #VOC #VoiceofCustomer #CustomerCentric #CustomerManagement

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Dos and Don’ts Of Rapid Innovation

2/15/2017

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When I talk with the business leaders and heads of strategy across organizations, the common challenge that they seem to face is to translate ideas into business profits. This very dilemma led me to delve deep on this topic. And, I noticed that there exists a ‘generic’ outlook regarding innovation, which is- Innovation is everybody’s business.

My point of view is – Yes ONLY for those doing incremental innovations such as cost-effective production, cheaper logistics, continuous improvement etc. While, ‘Break-through innovations’ CAN’T be everyone’s business.

Organizations, right at the outset, need to have complete clarity about the path they wish to take regarding innovation.

Remember “Innovation is a full-time job”. It simply can’t be done on a part-time basis. Also, skills needed for ‘Innovation’ are different from those required to run a core business or even for that matter a company’s existing product development department. Hence, if your manager has dual responsibilities of running your development lab and building innovation, means this is a sure sign of a failure! For path- breaking innovations to be a reality, you need to have an ‘Innovation’ leader with a dedicated taskforce and allotted finances.

Another significant element of succeeding with Innovation is effective handling of “Innovation killers”.

Now, what do I mean by Innovation killers? “This will never work! “Or “What is the NPV?” - Do you hear such or similar statements the moment a new idea is mentioned? If YES, then there are innovation killers in your organization.

Here are some of the ‘innovation killers’ I've observed, that dramatically reduce return on investment (ROI) on innovation. Read on and checkout if your organization hosts any of them-

'We welcome all new ideas' - This is one of the suicidal innovation approaches. Leadership should clearly inform ‘what not to do’ as once constraints or boundaries are placed, the team knows what innovations to focus on i.e. innovations are more strategic and happen not ‘by chance’.

"What is the NPV?" - Asking for a NPV information or for that matter any financial metric at the time of onset of the innovation project is again self-immolation. Instead the acceptance could be based on customer needs, trends etc.

"We are confident since we have lot of quantifiable industry data" - Industry reports are great to understand market landscape but customer needs have to be understood and documented only after spending quality time in the market to conduct the market research that helps to identify the unmet customer needs and key business model levers.

"Our brand and technology are better'- Instead ask ‘What is the unmet customer problem?” Secondly, do your brand and technology allow you to satisfy your customer’s problem better? If the answer is not an unequivocal yes, then go back to the drawing board.

"This will never work" - Typically teams in most organizations teams can be split into four main categories:

Innovation enthusiast: these are people who dislike maintaining status quo. They always like to take risks and seek new heights.
2C Profile-ist: This comprises majority people who are comfortable with status quo. However, with coaching and convincing (2C) will tend to be supportive and accept moderate changes.
Followers: This group doesn’t have any specific opinion. They simply tend to follow the majority route per se.
Nay sayers: These people constantly pose discouraging comments and excuses at every instant a new idea is presented. In an economic era where continuous improvement and innovation are lifeline for businesses, such ‘Nay sayers’ might turn out to be more dreadful than an under-performer.

Below are some methods I've successfully employed to effectively handle Innovation killers–

Demonstrate the damage they cause.
Stop excuses and limit destructive criticism.
Work hard to build an organizational culture that supports innovation.
Get buy-in and ownership from business unit managers.
Always have a widely understood systems-wide business process.
Tie ‘Innovation’ to ‘Company strategy’.
Spend enough resources on training and coaching Innovation teams.
Create an ‘Idea management system’: if necessary, use external experts to evaluate ‘Innovative concepts’ before allotting dollars. Set effective idea acceptance criteria and metrics in advance.

You can no longer expect to lead the pack in your industry simply with incremental continuous improvement efforts. Instead, you need to raise the bar and develop a business process that draws’ Continuous rapid innovation’.

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#ContinuousImprovement #Kaizen #Innovation #BusinessProcessManagement #LeanInnovation #LeanManagement

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Innovation is not an initiative. It’s a business process !

2/2/2017

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Innovation has been the buzz word for the entire past decade and shall continue to be. However, what does innovation mean to 21st Century businesses? Innovation equals profits.

innovation is not an initiative, innovation is a business process

Primarily innovation and comprises of-

Process innovation.
Product innovation.

Process innovation deals with internal operations such as- efficiency improvement, productivity increase, data management etc.

Product (or services) innovation deals with creating new products or services, to bring- in new revenue streams, develop products (or services) that add value to current initiatives, make customer experience more satisfying etc.

It has been found that typically 75% of industry based innovations belong to process innovation, while only 25% share is attributed to product innovation.

However, ‘Innovation’ is not an initiative. It’s a business process. The ‘Innovation’ process begins with market selection. It includes customer mapping, steps to uncover customer needs, analyze unmet needs, design or select a growth strategy and generate product (or service) concepts. Approved concepts then enter the 'Development' phase- a separate process.

If the ‘Innovation’ process were executed effectively, only winning products would enter the ‘Development’ process consequently, innovation success rates would rise substantially. This is especially because when ideas are generated around specific unmet customer needs, the chances of devising a solution of great customer value increases dramatically.

More so, knowing where to focus creatively changes the dynamics of idea generation. If you’re an organization that doesn’t wish to thrive on chaos, rather grow strategically, then Continuous Innovation is the way to go !