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UTASV Managemnet Consultants Email IDpradeepprakash2001@gmail.com

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UTSAV( Ultimate Transformation of Self and Values) Management Consultants is a strategic HR consulting and change management firm for pharmaceutical industry. It provides services and products for GMP Implementation, Regulatory Approval All Time Readiness from HR perspective, People Development & Assessment, and Knowledge Generation. It specialises in Good Behavioural Practices, GBP, for Pharmaceutical industry. We are the pioneers in GBP and spearheading the movement to transform the entire Pharma industry by inculcating GBP. This will enable Pharmaceutical organizations from India to compete with the best in the advanced markets of USA and Europe.

We enable organisations to realize their full potential by actualizing the talent of their people.

We believe people have immense potential that can be actualized in the pursuit of organizations' goals of GBP in a win - win manner. Our vision is to generate and disseminate knowledge, skills, attitudes and motivations using the state-of-art in the field of behavioural science in the service of this objective.

Our mission is to provide comprehensive services in the areas of acquisition, assessment and development of people and teams to enable superlative performance through GBP. And be the leading providers of services in the field.

UTSAV offers behavioral and soft skills training for pharmaceutical companies that include Organizational Change and Development, Training and Development, Psychometric Testing and Assesment and Performance Management for Pharma Industry.

We specialize in getting Pharma companies regulatory approval using behavioural-cum-cultural change and technical GMP skill based interventions so that Pharma companies do not falter in GMP, especially Data Integrity by agencies such as USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union), SFDA (China),NAFDAC(Nigeria), MEDSAFE(Newzeland), MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), MoH (Sri Lanka), WHO. We work with the QA team of the company and ensure that complete organisation complies with all the requirements of GMP in its day to day functioning. We ensure enduring changes in culture so that organization is any time ready for inspections.

Our Team

We are a team of behavioural scientists who specialize in behavioural dynamics in organisations. Our interventions range from training, talent assessment, policy guidelines, group dynamics management, leadership development, cultural change, surveys, individual coaching to designing HR processes.

Our unique style of consulting energizes the organisation to break new achievement barriers and that becomes our inspirational fuel to give our best.

Our team members are seasoned professionals and accredited in Organizational Change and Development Consulting, T group , Transactional Analysis , Achievement Motivation, MBTI, NLP, and similar specializations.Our work speaks for itself. Many of our satisfied clients in Pharma and Healthcare sector bear testimony of our effectiveness.

Our team is led by Pradeep Prakash, an engineer with masters degree in business administration. He has an experience of over 32 years in teaching, marketing, sales, manufacturing, training and OD consulting. He is a professional member of Indian Society of Applied Behavioural Sciences ( ISABS) New Delhi.He is passionate about discovery and spread of human processes through writing and training, spiritual growth of self and others and contributing meaningfully in making this world a better place to live in. He is pioneering the movement of Good Behavioural Practices (GBP) in India for Pharmaceutical Industry.Our Technical advisors are the leading names from Europe, Dr Jaap koster of PCS, Netherlands and Dr R Vidwans from India.

About Pradeep Prakash

Training and Development for Pharma by Pradeep Prakash

Pradeep Prakash has close to 34 years of work experience that includes teaching, sales, marketing, manufacturing, entrepreneurship and behavioural training & consulting after graduating in engineering and management.

He has been involved in training of thousands of executives from all the leading names in India and multinationals operating in India. He has successfully executed number of Organization wide cultural change initiatives in Pharma (especially GBP, Good Behavioural Practices paradigm for Pharma), Power and environment sectors leading to massive transformations and business turnarounds.

He has authored two books on Human processes & Self-empowerment, namely "Knock and the Door shall be Opened" and "Psychology of Joy". Also he has authored one novel, "Shreya-The Blossoming of a Kashmiri Pandit Girl", which have been widely appreciated in professional and lay circles and written various articles on behavioural learning and growth. His expertise in sales training, empowerment, group dynamics, achievement motivation, leadership, stress management and EQ programmes is well known.

He was board member of premier organisation of behavioural scientists in India namely Indian Society for Applied Behavioural Sciences (ISABS) from Jan 2007 till March2010.

Organizational Change and Development

Change is the only thing, which does not change. World or Business environment is changing on every moment. For excellence or for survival, one needs to be fittest to renovate themselves according to those changes. Those who adapt and accept changes at quickest will be possessing competitive advantage while others will be left behind.

Organizational change for GBP is a structured approach in an organization for ensuring that changes are smoothly and successfully implemented, and that the lasting benefits of change are achieved.

Organizational Development is a planned effort, led and supported by top management to implement GBP by improving an organization's visioning, empowerment, learning and problem-solving processes. It is a collaborative management of organization culture using the consultant- facilitator role combined with the theory and technology of applied behavioural science.

Key Benefits of Organizational Change & Development for GBP

1. Transforms the organization to reach its best.

2. Helps to gain competitive advantage

3. Encourages creativity and innovation

4. Eliminates restraining forces and strengthen driving forces for the easy achievement of organization's vision

5. Organizational culture, systems and processes get aligned towards the vision and the business goals of the organization.

Training and Development

"Sharpening the saw" is very important to be efficient and effective. Employees need to be trained or sharpened to perform their roles better at present and in future in implementing GBP.
Organizational effectiveness depends upon the performance of the people within the organization. Thus conscious efforts need to be provided for the development of employees to reach at performance standards by inculcating the culture of GBP.

Both inbound and outbound training is conducted in following fields with emphasis on GBP using following skill sets:

★ Interpersonal effectiveness,

★ Leadership Development

★ Emotional Intelligence

★ Spiritual Intelligence, Ethics and Meditation

★ Communications and Presentation Skills

★ Empowerment & Culture building

★ Team Building

★ T Group and Sensitivity

★ Stress Management

In addition to Training & Development, we also offer services in counseling and mentoring towards internalization of GBP.

Psycho profiling & Assessment

Psychometric Assesment

Competency Mapping for GMP

People are assets. Worth of them in an organizational context depends upon the suitability of their personality, traits and competencies with respect to their role in the organization. If they are aligned, performance will be better, else proper actions like training and development, transfer, counseling, mentoring etc need to be executed.

During our practice with variety of interventions in the organizations, we discovered that Senior Management has strong need to know the behavioural strengths and challenges of employees at all levels. This will enable them to leverage the strengths and mitigate the risks of their weaknesses coming in the way of business results.

We are offering precisely this and also how they fit in with the work culture of the organization.

Objective is to clearly delineate the various behavioural patterns and characteristics of an employee and how they can get better fit in variety of teams or leaders within the organization. In a way it will also identify their behavioural training needs.

We do this through our customized instruments, assessment centers and interviews. A complete, realistic and customized psycho-profile of the employee is built through these processes.

Performance Management

Performance Mangement

"GBP cannot be implemented fully unless we manage the reward and punishment system through PMS. Hence employee performance needs to be accurately assessed and improved periodically in the service of GBP. We help in designing the PMS for GBP so that it becomes an enduring feature of the work culture.

Key Benefits of Performance Management System for GBP

★ It enables in implementing GBP

★ Employee performance gets accurately assessed towards the goal of GBP

★ Appraisal data can be used for various HR Functions like Training & Development, Rewards and compensation, Succession Planning etc.

★ Employee motivation gets altered

★ Minimize employee dissatisfaction and turnover, etc

Competency Mapping for GMP

 Psychometric Assesment

Competency is the behavioural manifestation of knowledge, skills and attitude of a person in achieving particular outcome. For example, I will have competency of communication if I achieve an outcome that is desired to be achieved through communication using knowledge, skill and attitude possessed by me to communicate. That communication can be either written, verbal, non-verbal or combination of these. For instance, if I have communicated to you the meaning of competency by this example then I have some competency in communicating. How much competent I am in communication can be measured through seeing this competency expressed in variety of settings.

Obviously, professionals of a particular field vary in their functional competencies. For example QA professionals require variety of competencies to perform their role well in making the Pharma Plant GMP compliant. Whole lot of knowledge, skills and attitudes (KSA) will be required to get those competencies which come by exercising these KSAs in all kinds of experiences while performing their roles. Once we understand the competencies required for, say QA professionals, then we can hire the right people, train them to develop these competencies.This is the scientific way to enhance your effectiveness in getting the GMP compliant Plant in the shortest possible time. The same is true for Production, QC, Supply Chain, HR, Finance and other professionals required to make an enterprise successful. We are one of the pioneers in bringing the competency mapping framework in Indian pharma. It is one the most scientific methodology to train professionals and implement GMP effectively.

Please contact us for more details if you want to benefit from this state-of-art in behhavioural science innovation.

Training for Pharmaceutical Companies - GBP Pharma

Training for Pharmaceutical Companies - Good Behavioural Practices (GBP)

“At the heart of enduring success for any Pharmaceutical company lie Good Behavioural Practices- GBP”
Good Behavioural Practices - GBP emerged from our Behavioural Consulting with Pharmaceutical manufacturing Organizations. There is a business compulsion of implementing cGMP (Current Good Manufacturing Practices) in these companies if they have to get regulatory approvals for manufacturing and exporting medicines. In Indian context, getting regulatory approval from Indian authorities is an eye wash due to widespread culture of corruption. Majority of the Indian Pharma companies will miserably fail in regulatory compliances if strictly audited. Patient safety due to quality manufacturing practices does not seem to be important for Indian Pharma manufacturer. It is generalization, speaking for large majority of small scale and even medium scale set ups.

However, due to stricter auditing by International Regulatory Agencies such as WHO, US FDA, MHRA and the like, Pharmaceutical manufacturers cannot get or execute export orders unless they pass these agencies' audits. Result of this strictness is spate of disapproal of facilities of leading Indian companies like Ranbaxy, Aurobindo, RPG Life Sciences, Panacea Biotec and so on.

The real issue is that these big Pharma companies employ highly paid, technically qualified executives who fully understand cGMP but still they are failing these audits. It is not technical skill or knowledge which is lacking, it is the attitudes, mindsets, ethics and culture which is the biggest block in ethically implementing the cGMP

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Our Technical Advisors

Dr Jaap Koster

Dr Jaap Koster

Dr Jaap Koster supported companies with preparation for (GMP)-inspection, project management (refurbishments/new-facilities) or interim/crisis management. Performing audits for third parties and give training on regular basis both in companies as hotel training.He has worked mostly with biotechnology based products like vaccines but have done API manufacturing plants as well.He has Worked in Europe, USA and Asia.He is strong in organizing activities, built-in compliance during projects and building Quality Systems with an eye for culture, business and am providing "out of the box thinking" and practical solutions.He specialtizes in : GMP, Engineering, Validation, Quality Systems, Interim Management and Crisis Management.



Dr Rajendra Vidwans

Dr Rajendra Vidwans

Dr Rajendra Vidwans just finished the long running, QMS, QA, xGMP assignment for sterile Biologicals manufacturing company very successfully culminating into passing of audit done by a tough 6 member team of WHO. Toughest assignment done successfully. He is effectively using 36 years experience in Pharma operations incl production, projects, Quality, now.working independently in GMP audits, inspections, training, GMP consultations, Quality systems, Risk assessments etc.He has experience in putting up and operationalising all sterile formulations projects and production, for last 36 years culminating in US FDA approval for a facility he headed especially, oncology, LVP, SVP, lyophilisation projects and production. He has headed many plants of the companies he worked with, always looking for advanced technologies and fair management practices without loosing productivity.
Specialising in choosing correct machinery for injection plants and operating them. Sterile facilites project and operations have become my passion and job over theyears. Specialties: Quality system installation, training, Pharma project design, layouts, machinery selection, SOP corrections and training, excellence in manufacturing and quality.

Distance Learning Program for GBP

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“At the heart of enduring success for any Pharmaceutical company lie Good Behavioural Practices- GBP”

We are pleased to announce first ever distance learning programme on Good Behavioural Practices. With this programme we aim to educate the Pharma executives at senior levels( with minimum ten years industry experience) on behavioural knowledge, skills and attitude necessary to implement GMP and QMS.

This programme has three months duration with video lectures, study material and three days contact programme. At the successful completion of programme, requiring written test and viva voce, the participants will be awarded certificate of completion of First Level GBP programme. ( Higher Levels will be available in September,2014).

Benefits for the Sponsoring Organization

1. It will enable them to implement QMS/GMP on enduring basis and efficiently without slippages.
2. Will have motivated Quality conscious executives

Benefits for the Participants

1. Equip them with knowledge, skills and attitude necessary for implementing QMS/ GMP in Pharma industry;
2. Enhance their relationship and behavioural skills to make them more effective in their professional and personal life;
3. Achieve more in life through increase in achievement drive.
4. Facilitate quicker growth in professional ladder

Course content

1. GBP Framework for implementing QMS/GMP
2. Understanding Human Behaviour- Part I
3. Understanding Human behaviour Part-II
4. Case studies analysis of challenges in implementing QMS/ GMP
5. Behaviour Skills of relating, motivating, giving feedback and coaching
6. Ethics
7. GBP Attitude training through contact programme

Logistics

Course will be delivered through following methods:
1. Video lectures available for download
2. Study material for each video lecture (soft copy)
3. Contact programme of three days at the end of six weeks

Admission Eligibility Requirements

1. Minimum ten years experience in Pharma manufacturing industry at senior executive level
2. Bachelors degree
3. First condition can be relaxed in exceptional cases

Award of certificate on completion At the end of Three months, a written exam will be conducted followed by Viva Voce. On successful completion of the same, a certificate of First Level GBP programme will be awarded to the candidates. (Higher Levels will be available in September,2014).

Commercials
Investment for Level I GBP programme: Rs 50,000 only plus 12.36 % service tax as applicable. 20% discount is allowed for 5 or more nominations and 30% discount is allowed for 10 or more nominations from the same organization.

Course Director

Pradeep Prakash
Email : pp@gbppharma.com, pradeepprakash2001@gmail.com
Mob: +919810009311

GBP Manual

Many organizations get into the chaos paradigm because of the lack of clarity in GBP processes and the absence of proper policies and procedures. Proper clarity of the GBP processes and formulation of policies and procedures helps the organization to avoid interruptions in the achievement of goals and to focus on the most important priorities. We enable organizations to build in a step by step manner an exhaustive GBP Manual for the same.

Ethics and Sustainability for GBP

Pharma Ethics

Ethics and sustainability is an area where many organizations slip. They are not able to resolve the dilemma of short term versus long term goals and hence fall into the trap of long term failure. We specialize in enabling the employees and top management to understand various critical choice making processes in implemening GBP involving ethics.

Key Benefits of Ethics and sustainability

Creates credibility with public, stakeholders and employees

Increases and sustains profit in the long run

Employees feel proud of the company and their morale gets enhanced

Gets support from every stakeholders including employees, customers, government etc for the development of the organization.

Blog: Ethical Behaviour is not for the Chickenhearted.

Pharma - Behavioural Issues

These are the news collected from trustful websites.


1. WHO-GMP purchase norms to hit MSMEs


2. USFDA bans two Indian plants on GMP violations


3.Ipca stops API export to US as FDA finds fault at Ratlam unit


4. USFDA finds procedural lapses at Wockhardt's U.S. facility

5. USFDA asks Indian pharma leaders to make quality their top priority


6. USFDA cities torn records, unclean toilets for banning Sun Pharma's Gujarat plant


7. Govt mulls USFDA-like checks to keep MNC drug makers on toes


8. USFDA slaps import alert on Sun Pharma's Karkhadi plant


9. India warns USFDA of false whistles


10. US Food and Drug regulator to deploy more inspectors in India


11.Innovator or generic, building quality will build reputation: Margaret Hamburg 


12. Bitter pill: US issues alert on Ranbaxy again, shares fall 5%

13. US FDA to continue focus on India's pharma companies


14. UK patients are not overconcerned about Indian drugs quality: Gerald Heddell


15. BIG BROTHER IS WATCHING


16. Heading India Like Scaling Everest for US FDA's Lal
17. Nine drugmakers have been fined a total of 146 million euros

18. Interview with Mr. Arun Sawhney, MD&CEO. Ranbaxy Laboratories Ltd

19. US FDA wants RPG Life Sciences for violation of manufacturing norms

20. Shantha Biotech

21. Dr Reddy's sued for 'infringing' thyroid injection patent


22. Wockhardt Story


23. Frensenius Kabi Oncology


24. Ranbaxy Laboratories Ltd - 16th Sept. 2013


25. Strides Acrolab - 16th Sept, 2013


26.Cipla shares fall after US FDA found deficiencies at Goa unit


27.Dr Reddy's gets 4 observations from USFDA for Telangana plant


28.US FDA flags issues at Sun Pharma’s Halol plant


29.USFDA issues 3 observations at Alembic Pharma’s Panelav facility


30.Indoco Remedies receives 8 USFDA observations for its Goa unit


31.Dr Reddy’s to USFDA: Staff giving illogical answers not appropriate


32.Alkem Laboratories falls 11% as USFDA issues 13 observations to Daman plant


33.Despite spending big on legal & professional consultants, FDA woes continue to haunt pharma companies


34.Dr Reddy's gets 8 observations from USFDA for Duvvada plant


35.USFDA issues warning letter for Cadila Healthcare's Moraiya facility


36.Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection

HR Communication & Newsletters for GBP

GBP based communication is a powerful tool to bring about change towards GBP. And it is an art few know how to implement in organization. We have developed a special expertise in the same and many clients have used it to their immense benefit. Please find below the actual samples of communication designed by us for the CEO of a Pharmaceutical orhganization.



Samples of Communications (names and identities changed for confidentiality purposes)

It will have many benefits including but not limited to: minimize employee dissatisfaction and turnover, reinforcing the culture of GBP. It resolves the issues in the organizational communication process and align the process towards the business goals and GBP.

We also facilitate in publishing newsletters on various Human Resource and Organizational Development topics currently happening in the organization.

Good Behavioural Practices- GBP Audit

It is well established in our experience of consulting with Pharma organizations that cGMP cannot be implemented without first establishing GBP. Establishing GBP requires extensive cultural transformations. Where exactly in cultural and behavioural dimensions an organization stands will determine whether cGMP will be successfully implemented.

GBP Audit is a proprietary tool designed by UTSAV to enable Pharma organizations understand their readiness and maturity in implementing cGMP on enduring basis.

Objectives :

Objectives to attain GMP through GBP

It’s objective is to scientifically and methodically assess variety of cultural and behavioural dimensions at all levels of management that enable and disable implementation of cGMP on lasting basis and not merely to clear statutory/ regulatory audits.

GBP-Audit report is exhaustive document that lists variety of behavioural/ cultural issues in order of criticality and importance (Critical, Major, Minor etc). Once this audit report is available, one can go about resolving the identified issues in a scientific manner.

GBP Audit also rates the organization through its GBP Score Card in terms of its maturity in GBP implementation.




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Methodology and Dimensions:

Assumptions:

1. Management appreciates the value and critical importance of human element (behaviour and culture) in implementing cGMP and is serious about tackling behavioural issues.

Basic Steps:

1. We will do our primary interviewing with target group (about 10% of the entire population), selected at random as well as design, from all the levels to understand the basics of work culture and variety of important behavioural issues in the organization;

2. For instance following dimensions may be examined in minute details:

a. Vision, values and mission of the top management as practiced and as professed;
b. Current skill base of the employees in relation to the various roles and role requirements;
HRD subsystems available today to build its competency base for the present, immediate future and long term goals;
c. Leadership;
d. Learning culture and systems including knowledge management.
e. Performance management system;
f. Work Culture of the organization including ownership and responsibility;
g. Work Climate and employee motivation levels;
h. Values as practiced at middle and lower rungs of employees;
HR Communication & Newsletters

HR Communication & Newsletters

GBP based communication is a powerful tool to bring about change towards GBP. And it is an art few know how to implement in organization. We have developed a special expertise in the same and many clients have used it to their immense benefit. Please find below the actual samples of communication designed by us for the CEO of a Pharmaceutical orhganization.



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Blog

Blog

Good Behavioural Practices Training for Pharma can ensure competitive success for Indian Pharmaceutical industry. However, Indian Industrial culture is still to fully come out of ‘Chalta Hai’ mindset. Everyone knows that large numbers of Pharmaceutical plants need vast improvement in the work culture to compete in the world markets.





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Free Soft Skills Training Presentations

Pharma - Behavioural Issues

Pharmaceutical companies face complex issues that grow more challenging by the day

One of the most crucial questions facing the industry, though, is what leadership skills companies will need to navigate this complex and changing landscape—and how current pharmaceutical leaders stack up.




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Video

Videos

The way your employees feel is the way your customers will feel. And if your employees don’t feel valued, neither will your customers. — Sybil F. Stershic.

Here we are providing some videos of training programs by Pradeep Prakash. Organizational Development is a planned effort, led and supported by top management to implement GBP by improving an organization's visioning, empowerment, learning and problem-solving processes.

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