Over the years, the range of the services we offer has widened, as more and more exposure over the years led to more and more possibilities to integrate our abilities to offer a holistic service-set. The services we offer today enable our clients to seamlessly integrate one vision into technology, design, and language for enhanced business benefit.
Our core services can be classified under the following headings:Project Consulting
At the end of the day, it is an accepted fact that project success is all about your project execution model and the overall efficiency of your setup. I have been fortunate to have worked with numerous organizations helping them fine-tune their project strategy and streamline their CQV phases, leading to better services and processes, leading, in turn, to enhanced client satisfaction and overall project delivery within scheduel and on cost.
As a Project consultant, I offer the following services geared to help you get the best out of your project setup:
Project Execution Strategy
- ASTM E2500 Delivery Execution and Training.
- Project CQV Strategy and Training delivery.
- Operational and Process Flow Consulting.
- Product / Service Lifecycle Review.
- QA & Regulatory Compliance.
- CQV Project Management.
- Cleanroom Qualification and EM Specialist.
An effective high-level project execution strategy has typically been seen to be the secret behind the success of most companies projects that have done well. Typically, every company has an avowed long-term vision, which is organized into smaller time-bound missions. Your project execution strategy is your company´s chosen path towards these missions, and are critical for their success.
Working closely with your core project management, I study, capture, and present your existing project execution strategy.
Post project execution strategy capture, I engage your management team in sessions dedicated to strategy and strategy implementation analysis. Typically, these sessions help you identify the gaps (if any) within your business strategy, and help your team arrive at a better understanding of the manner in which your core strategy has translated into processes and procedures on the work floor.
By the time existing core project strategies, processes, and procedures are captured, your core project management will be ready to engage in discussions leading to a reevaluation and enhancement of your business strategies. This will, in turn cascade as evolved processes and procedures within your organization. The net result of this exercise will be enhanced integration across the various teams within your organization and a greater clarity in terms of where your organization needs to go and what it needs to do to get there.
With enhanced processes and procedures captured and documented, your team will be in a position to chalk out steady plans for training and materials creation for identified departments within your organization.
As newer and newer technologies emerge, your organization will be ready to evolve to the next level of oualification efficiency and will be ready to handle emerging regulatory requirements very much by itself.CQV Consulting
Apart from streamlined processes and procedures, operationalizing a project vision also requires measured investment in people and technology in terms of both off-the-shelf and custom-built applications. Over the past years, I have worked with numerous companies, helping them identify their people and technology-process related requirements, offering guidance towards choosing the right people and proces to suit their current and future project requirements, and in creating and customizing solutions to suit their specific project needs.
I offer the following CQV related services:
- Design review, compliance and approval.
- FAT & SAT Documentation and certification.
- Conducting all phases of Commissioning, Qualification and Validation for all products, equipment, utility systems, facilities, and processes.
- Development of process and equipment protocols for formulation, labelling, filling, and packaging for all products including all support systems.
- Development of Cleaning Validation protocols, cleaning assessments, and provide relevant information for cleaning method development.
- Authorizing/Revising validation standard operating procedures and validation master plans.
- Oversee and coordinating validation activities for process, equipment, instrument and cleaning validation studies.
- Assessing project demands and execute the project within the timelines.
- Providing validation related guidance in project meetings.
- Assurance to full compliance with cGMP's and other related requirements.
- Collecting, collating and analyzing validation data and prepare final validation reports for approval.
- Reviewing data, validation protocols, and reports.
- Development and Effective Implementation of cGXP/QMS/SOPs.
- Development and Harmonization of Corporate level documentation
- Development of Organization level quality documents
- Conducting detailed Risk Assessment and GAP analysis
- Effective CAPA Management
- Providing Training to all level work groups
- Third party Vendor Audits & certification
- Technology Transfer Documentation
- Facility compliance/Mock Audits/Quality Audits
- Conducting Unbiased Failure Investigations
- Readiness for Regulatory/ISO Audits
- Regulatory Audit Response (National & International)
- Development of Document Management System
- Effective implementation of 21 CFR compliant online QMS system.
Technology has been this generation´s greatest enabler, the greatest source of change, globalization, and expanding bottomlines. As a consulting professional who has grown and flourished among the technological advances that have marked our generation, I have evolved a set of specific services designed to offer businesses like yours the greatest project leverage at minimal costs. This also also allows streamlining the process path and reduces schedule delays and costly project overruns.Project Management
For reasons of both security and urgency, organizations are often wary of offloading complete application development or management tasks offsite. For such companies, having an experienced and dependable source of management consulting can be optimal. Your project stays on your premises and is handled either by your own people or consultants who work onsite, and the project and team is managed by a capable and experienced manager. Leveraging a combination of onsite and remote monitoring and systematized planning, i can help you reduce your application development / management costs by offering dependable project management services. With an experience of executing a number of projects for clients of various sizes and requirements, I have the ability to simplify your software needs without your incurring unnecessary expenditure on these counts.
Please do get in touch with me to explore project management options that work for your organization.Process Consulting
Different organizations operate differently, and one of the main reasons for this is that their goals are different, as is their overall business strategy. My Proess Consulting service offering aims to help you translate your project vision and strategy into viable policies, operational processes, and on-the-floor procedures. With every aspect of your operations optimally architected, designed, documented and monitored, you can rest assured that the overall on-the-floor efficiency within your organization shall see a significant improvement.
With continual process improvement initiatives like training and KPI reformulations, you save more and more in terms of both time and money while evolving into a more stable, compliant, more integrated organization. Integrated operations, in turn, leads to better service delivery, leading to greater client satisfaction and enhanced profitability.
I combine state-of-the-art tools, techniques and operational metrics to offer you rapid process-driven efficiency at minimal rates, helping you quickly achieve ROI and scale your organizational capabilities to deliver more services -- better services -- using the same teams.
For more information on how my Process Management services can hep you reinvent your project organization, please contact me.