Our Technical Advisors
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 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.â€¨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
“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
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
7. GBP Attitude training through contact programme
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).
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.
Email : firstname.lastname@example.org, email@example.com
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
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.
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
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.
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.
Methodology and Dimensions:
1. Management appreciates the value and critical importance of human element (behaviour and culture) in implementing cGMP and is serious about tackling behavioural issues.
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;
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;