Brief: Write a press release which provides the fundamental information and outline of the Executive Program in Pharmaceutical Quality Management which NSF will provide in India. Adhere to the branding guidelines and professional tone of voice which NSF presents across all collateral. The aim of the release is to raise the profile of our course offering within the pharmaceutical sector.
EXECUTIVE PROGRAM
IN
PHARMACEUTICAL QUALITY MANAGEMENT
Encompassing ICH, WHO and FDA Requirements and Best Industry Practices
For companies who want to grow their business in Europe and the U.S.
Successful candidates will be awarded an internationally recognised certification from NSF International and IDMA.
Challenges Facing the Pharmaceutical Industry
India takes pride in being the world’s third largest pharmaceutical generics producer and has the highest number of FDA and MHRA GMP-approved manufacturing plants outside the U.S. and Europe. Despite these achievements, the challenge of remaining in an ongoing state of GMP compliance continues to be the main concern for the pharma industry. India has seen a resurgence of breach of data integrity and quality issues, and the EU and U.S. regulatory requirements continue to become more stringent and rigorous.
Technical and QA professionals in India are trained in GMP compliance mainly through experience and need a formal education in pharmaceutical quality management of international standards.
Sixty-four percent of companies say a shortage of skilled staff is curtailing their growth (Deloitte).
‘There is an urgent need for more effective training, coaching and mentoring to remove fear and empower.’ (Dr. Azaj Hussain, former U.S. FDA Deputy Director of the Office of Pharmaceutical Science)
We live in a world of ‘brutal disruption’. Brexit, Trump – what next? The regulatory landscape will continue to change and prosperity awaits those who can do the basics to Ph.D. level.
How Training Can Help
Our unique, world-class Executive in Program in Pharmaceutical Quality Management provides the training needed to comply with GMP regulations. Course modules are very interactive and led by world-class, international experts. Participants will learn best-in-class practices and apply them in practical problem solving and real-life case studies. They will learn by doing.
In addition to module-specific content, participants will be provided with a deep understanding of simplification, risk-based decision making and advanced problem solving skills. Participants will receive practical instruction on the leadership and communication skills required to add value to their organisations and to successfully interact with regulatory agencies in the U.S. and EU and other key stakeholders.
This advanced education program covers best industry and regulatory practices presented by world-class tutors with 35 years of hands-on experience. It is designed for companies who aspire to be the best and who want a secure future.
Why Choose NSF?
NSF’s Executive Program in Pharmaceutical Quality Management is taught by world leaders in PQM. Based in the UK, NSF (previously David Begg Associates) have a global reputation for excellence in PQM. Our course tutors have a minimum of 30 years’ global, hands-on industry experience. Many are former MHRA inspectors. All have profound knowledge of PQM and some have authored ICH and WHO guidance documents.
NSF has trained regulators from eight regulatory agencies including those in the EU and USA. Respected by regulatory agency and industry associations, NSF has excellent relationships with IDMA, ISPE, PDA organisations and U.S. FDA, WHO and EU regulatory authorities.
With offices in Delhi, NSF has an excellent understanding of Indian culture and the Indian pharma industry, gained over the last 30 years.
Benefits of Training
Those attending this program will gain the skills and knowledge to help their companies improve business performance and regulatory compliance. Clients who have attended NSF programs have generated $ millions in savings. For example by:
Reducing repeat deviations by 78 percent
Reducing ‘human error’ deviations by 67 percent
Achieving 99 percent ‘right first time’ at product release
Using risk-based decision making to simplify processes and systems, and to focus resources
Achieving zero regulatory observations following an audit
Attendees will also:
Change how they think. NSF courses are designed to change behaviours, not just provide knowledge. Participants will be able transfer the learning into their workplace.
Learn best industry practices in PQM so that their companies can compete with the best
Gain an in-depth understanding of the critical aspects of PQM (see Course Modules)
Leave with the knowledge required to help protect their company’s legacy and reputation and future
Course Format
The program is presented in five modules, each comprising four days, over a 10-month period. One module takes place every other month. Training takes place in Bangalore at the beautiful campus of Acharya College. You will receive:
A minimum of two tutors per module, to ensure a good tutor-to-delegate ratio
An intensive, distraction-free and highly interactive learning environment using real-life case studies and problem solving exercises
One-on-one mentorship and guidance from course tutors
A written assessment to complete for each module
Course Modules
Throughout each module we will also develop your leadership skills to prepare you and your companies to succeed. Case studies and problem-solving exercises will be used to improve your skills in risk-based decision making, communication, crisis management, problem solving and change leadership. Best-in-class practices relating to data integrity, process validation, technology transfers and more will also be covered.
Some of the key topics covered in each module are provided below.
Module One: Pharmaceutical Quality Management Systems – Best Industry Practices
Tutors: Mr Martin Lush and Mr Robert Hughes
How to ensure your QMS is regulatory compliant, improves your competitive edge and drives business improvements
Integration of quality systems across the product lifecycle (quality systems approach for cGMP implementation, from philosophy to practice)
Making use of risk information to drive improvements (risk-based decision making)
Senior management roles and responsibilities for the QMS -- who must do what
The essentials of data integrity
The art and science of simplification
Batch release system: How to achieve 100 percent ‘right first time’
How to become stronger and better following complaints and recalls
Product quality reviews: How to use data and knowledge to drive improvement
Management review of quality system and use of quality metrics (measuring only what matters)
Continuous quality improvement and the cost of poor quality
Module Two: Managing Change; Change Control and Deviations
Tutors: Mr John Johnson and Mr Rob Hughes
Change control: How to use your system to:
Stop unnecessary change to ensure resources are focused on changes that only add value
Approve changes in minutes, not hours or days
Improve successful implementation of approved changes
Make change control fast and efficient
Deviation management: How to ensure your system:
Prevents repeat deviation incidents
Is simple, fast and effective
CAPA management
Investigation skills, instructions and report writing skills
Module Three: Human Factors – Getting People to Follow the Rules
Tutors: Mr Martin Lush and Mr Rob Hughes
Human error: Causes and prevention
Behavioural GMP: How to improve behaviours in the workplace
How to get the best from your people and keep them
Train vs. educate: How to build second-level leadership for quality management
Making your quality organization fit for purpose, whether centralised, decentralised or site managed
How to overcome pitfalls in remediation programs and integrate them within the PQS
Fostering a culture of quality (how to identify the relationship between company quality performance and prevailing quality culture and make quality normal, easy and rewarding)
Module Four: Transforming Data Into Information – The Practical Application of Statistics to Transform Your Business
Tutors: Dr Peter Gough and Mr Chris Harris
Summarizing and visualizing data (histograms, probability curves and box plots)
Confidence in your means and proportions
Statistical process control
Control charts
Fishbone diagrams and Pareto charts
Process capability
Six Sigma
Statistical testing
T-test
ANOVA
Outliers
Regression analysis
Design of experiments
Multivariate analysis
Module Five: Quality by Design, Process Validation and Technology Transfer
Tutors: Dr Peter Gough and Mr Bruce Davis
Quality by Design (QbD): ICH Q 8, 9, 10 and 11
Modern approach to process validation
Process design
Application of quality risk management to process validation
Tools for process validation implementation
Equipment and utilities qualification
Applying statistics for process validation
Process performance qualification (PPQ) – How many batches?
Process validation strategy and planning
Ongoing/continued process verification
Packaging validation
Technology transfer
Laboratory electronic data management
Course Fee:
NSF and IDMA have worked together to offer this course as a service to the industry. The course fee is being charged to cover the expenses related to design, delivery and administration of the course. The course is offered for a cluster of 30 to 40 delegates to distribute the cost. The course fee works out to approximately 8,100 GBP + 15% service tax + actual travel and stay expenses.
This type of program would typically cost approximately 150,000 GBP for a company for to engage the faculty for 40 tutor days for in-house training compared to 10,000 GBP for the entire program.
Next Steps: Your Call to Action
If you would like more information on this unique opportunity please:
View our free 30-minute webinar ‘NSF and IDMA Executive Program in Pharmaceutical Quality Management’ by Mr Martin Lush, President, NSF Health Sciences on our website: http://www.nsf.org/info/pbwebinars
Contact Martin Lush at martinlush@nsf.org
S.M.Mudda
Chairman, IDMA,
Regulatory Affairs
smm@microlabs.in
S.V.Veeramani
National President,
IDMA, Mumbai
svv@fourrts.com
Martin Lush
President,
NSF Health Sciences, UK
martinlush@nsf.org
CAMPUS: ACHARYA COLLEGE, BANGALORE