Traning
Training helps “Gain solutions to your company’s immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements”.
Identification: SPRASH identifies relevant categories of employees for particular training.
Timelines: SPRASH develops and implement codes of conduct, policies and procedures, and effective training-all within a set timeframe.
Completion Rates: SPRASH completes 100% of their training with specified no. of hours.
Tracking: SPRASH keeps a track of training and employee attendance.
SPRASH PHARMA believes to run a good training system which provides the process for ensuring all employees receive adequate, relevant and documented training to enable them to perform their assigned functions safely and with compliance with applicable guidelines / regulations.
Key points for Quality Pharmaceutical Training:
* Companies should organize their activities along functional lines with each department training its own member.
* Basic needs for training in pharmaceutical companies:
* Extend quality training to all departments
* Perform specific departmental training in each functional area.
Quality is EVERYONE’S responsibility!
Quality training should be, and is required by cGMPs, across the company.
Incorporate quality-related concepts into all management training, and provide quality tools for other functional areas.
A quality training program should start at the top of an organisation and flow directly to the bottom of the organisation. It can be effective to create training task force, or individual with support from upper management, who coordinates training and is responsible for its implementation.
1 Standardized Classroom Training Programs
Training your staff and keeping them current on regulations, procedures, and best practices is an important, yet never-ending undertaking. With our large repository of training modules, our expert trainers can do the job for you.
Methods for training may in-corporate the following:
* Computerized systems (PowerPoint presentations)
* Video tapes / Speakers (audio/visual)
*Manuals or Booklets
*Tours
*Applications of instruction & training subjects with company problems / issues
* Role playing
* Case examples
2 Customized Classroom Training Programs
Your company/institution is unique; you have your own culture, standard operating procedures, and projects.
Sprash Pharma Consultancy offers tailored onsite training to the Pharmaceutical, Biotech industries, and Food industries. Sprash is experienced in developing “Customized Training” that communicates your goals, your way of doing business, and your project specific information to your staff.
3 On-site Classroom Training
*Opportunity to “ask questions” about project–specific issues without the concern of revealing confidential
information to other industry attendees
* “Personal interaction” with the industry experts
* Immediate “verbal feedback”
* “Interaction” with other learners
* Immediate adjustment of instructions
*( “Employee learning” to promote consistency and standardization
* Opportunity for constructive “team building” among staff members
* Limited time away from the office and “decreased travel costs”
4 Training for different levels of Personnel Upper Management
* Should be a “broad coverage” of all quality activities of the company
* Establish a “link” between Business Goals and Quality
* Focus on “results” – not techniques
* Evaluate separation of training between upper management and rest of the company
* Some suggested topics:
*The job of upper management
* Annual Quality improvement initiatives
* Motivation and Training for Quality
* Quality initiatives around the world (future quality issues)
Middle & Lower Management
* Evaluate offering a single training program or designing unique categories
* Managers are results oriented but also have departmental responsibilities
* Major portion of the training should focus upon Quality Improvement
* Some suggested topics:
* Quality Mission
* Supplier relations
* Manufacturing
* Product development
* Inspection & Testing
* Field Issues – Complaint or Recalls
* Motivation for Quality
* Future quality issues
* Quality Tools
General Employees
* Course outline broken down as per specific function with general sections covering all areas
* Have course handouts on the topics covered
* Provide “Tools” for them to use in their daily work lives
* Some suggested Quality introduction topics:
* What is quality?
* Evaluation of quality tools
(Diagrams & Control Charts)
* Evaluation of customer needs
* Future products / projects
* Field Issues
* FDA initiatives or Issues
* Suppliers to discuss their operations
* Representative from other sites
“You can’t audit in quality”, as the saying goes.
While a comprehensive auditing program is an important component in any QA program, Quality must be built-in from the beginning.
Sprash experienced quality team can act as an extension of your own by providing strategic consulting in the regulatory and
manufacturing areas, including
* Writing and Reviewing QA policies, Manuals and Procedures.
* Performing GAP analysis against Regulations.
* Serving advisors for Project Managers and QA Managers.
* Training staff for Regulatory Requirements & Research.
* Conducting Process Flow Assessments for cGMPs.
* Developing Clinical Trial Materials Labeling.
* Conducting due diligence of Manufacturing & Processing Systems.
* Serving as liaison among Contractors (API, Labs, Manufacturing).
* Assisting start-up companies with Manufacturing, QA, Staff.
* Developing regulatory strategies & plans for the FDA.