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The Process Element

Many leaders in the pharmaceutical industry continue to hold onto the belief that success comes from compliance with regulatory requirements. That is history. The best management system for any process that operates in your organization is specific to you and your system, it is the one that works best for you. “Cookie cutter” solutions don’t work—ones that are tailored to your needs do. We oversee and design programs for your process, investing time, effort and energy on helping you understand the requirements for an efficient business. We get a picture of how your operation works so that we can help you establish how your operation should work tomorrow and this “value streaming” service brings more control and profitability to your processes, by tweaking the processes that you have in place.

Our Services

TECHNICAL TRAINING SERVICES

  • CGMP in Pharmaceutical operation
  • GxP in Quality Control activities
  • Training on Basic analytical techniques–Analysts’ skill development
  • QC Productivity enhancements and Risk mitigations
  • Quality Risk Management training
  • OOS/OOT/Deviations -Investigations, Root Cause Analysis and CAPA
  • Simplification of Standard operating procedure
  • Technical writing
  • Cleaning basics, Qualification & Validation of cleaning
  • Disinfectant & Sanitization
  • Sterilization techniques
  • Media-fills and process simulations

SOFTSKILLS & COMPETENCY BUILDING SERVICES

  • Communication Skills
  • Writing & speaking skills
  • Grooming and presentation Selling skills
  • Leadership training
  • Negotiation skills
  • Influencing Techniques
  • Leveraging Team Strength
  • Conflict Management
  • Personal Effectiveness
  • Problem solving
  • Environmental monitoring program-concepts and Practices

CONSULTING SERVICES

  • Analytical & Process productivity improvement
  • Regulatory alignment, Quality Risk assessment & remediation services
  • Robust Stability study management including data review
  • ANDA document review and guidance
  • Analytical method evaluation and issue resolution
  • Project management, Qualification &Validation; Services
  • Auditing and gap identification services (with specific emphasis on Data integrity / governance)
  • Supply Chain Management review and optimization
  • Good microbiological practices and compliances
  • Developing and writing select sections of the dossiers
  • Biologics and Pharmaceutical unit operation optimization services
  • Sterilization and terminal sterilization cycle development studies
  • Sterility assurance package development

The People Element

One of the biggest challenges for the bio pharmaceutical industry is in surpassing individual barriers and bringing the ability of looking at a summation of individual excellence, leading to creating high calibre performance. Expression of great knowledge through great implementation is an essence that provides and embeds drivers for sustainable growth. With the constantly changing and stringent requirements of regulatory bodies coming alive at the shop floors, concepts of team working is no more restricted to the managerial cadres. A cascade of management philosophies is becoming a daily requirement. Criticality in review and ability to look through the data is an art that makes the science of drug manufacturing so complex. The lists of To-Do goes endlessly growing. Training and constant nurturing is a requirement for individuals and teams to perform the functions. It is important that training is not seen as a one-off exercise. VIENNI enables you with this support of working with and in creating teams that become self-propelled. Being a part of a great team is always a motivation however, the occasions of struggling along in isolation many-a-times is recalled as experiences. The need to be considered an integral part of a team is fundamental to identity of an individual or a team of people, as the benefits of team working brings this need-of-association to the forefront of operational efficiency in any service provision/allied industry. Team working also means

  • More creativity leading to more ideas and better results
  • Increased employee satisfaction
  • The opportunity to up-skill, develop and acquire new skills
  • The speed at which things can be achieved
  • A sounding board for testing out ideas and thoughts
  • A support network that the team members or other teams can draw on

Teamwork can increase competitiveness by:

  • Improving productivity, quality and encouraging innovation
  • Taking advantage of the opportunities provided by technological advance
  • Improving employee motivation and commitment

To remain competitive organizations need to make optimum use of business processes and people, if businesses are to thrive or even survive. VIENNI enables you with this support.