GMP Training | Medical Device. Pharmaceutical. Quality Systems.
GMP Training.
The objective of Good Manufacturing Practice (GMP)…
.. is to ensure user safety. The user being a patient, member of medical staff, members of the community, any one of which, may be negatively impacted by an adulterated, poorly designed or poorly manufactured product. The GMP’s when effectively implemented, create a manufacturing environment and management control system where safe, quality, reliable product, is consistently produced from a manufacturing process. The GMP’s are not and cannot be specifically prescriptive as they as designed to apply to a broad range of manufacturing environments, however, by understanding and applying the GMP’s as intended, a manufacturer can be confident in the integrity of their manufacturing process.
Medical Device:
Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
Information & Training presentation >>>
The GMP’s & Manufacturing.
The GMP’s aim to establish a management and control framework which spans the entire life cycle of a product, ranging from the initial design stage, through to product development, clinical testing, manufacturing and follow-up market use feedback. Information gathered during the product design, during clinical testing, from patient feedback all need to feed into the product specification. The product then needs to be manufactured to the required specification, with comprehensive validation and verification processes in place, which demonstrate that the manufacturing process can consistently and repeatedly output product as per the original design intent.Validation is a key component in Good Manufacturing Practice.
Products and processes need to be validated, where verification alone cannot continually confirm operational and output performance to requirements. Compliance with GMP will require performance of a Validation gap analysis, where the necessity for validation to be performed can be measured against the level of validation which is currently in place. The gap analysis will also determine the need for and effectivity of on-going revalidation activity.Documentation requirements for GMP compliance.
A controlled documentation management system is a critical component in GMP compliance. In order to demonstrate compliance during an assurance audit, or in the event of litigation, etc., clearly readable, easily retrievable procedures, specifications, … records will be essential to demonstrate the effective adherence to good manufacturing practice requirements. The documentation management system can encompass electronic controls such as electronic records and signatures, however the same GMP requirements will apply and need to be implemented.Change Management and Control.
Linked to the documentation management system, change management and control is essential to ensuring continued compliance to GMP requirements. As outlined above, while GMP is primarily focussed on manufacturing controls, product or process change needs to take account of experience and development in patient use, in regulatory expectations, in technology, etc.. This aspect of GMP gives rise to the cGMP’s, the current good manufacturing practices, where product and process change is expected to happen as a result of ongoing factors which are often external to a business itself.Risk consideration in GMP implementation.
When implementing GMP control, the risk to stakeholders must be considered and needs to form the basis for where the GMP efforts will be applied. The stakeholders first need to be identified then rated in terms of prioritization. Examples of stakeholders being patients, prescribing medics, employees, etc. When looking at GMP compliance, risk will focus on product quality, safety and efficacy. Where processes, the environment, human actions, procedures or materials create the potential for serious risk, then the effort applied and controls implemented to ensure GMP compliance, will need to reflect the level of inherent risk.GMP Training.
Training of all individuals who can impact the quality, safety or efficacy of a product is an essential pre-requisite for GMP compliance. Training will be an on-going effort, which will require the determination of the competence needs for all tasks, then performance of a competence gap analysis to determine the training needs. The training needs will need to be continually re-assessed, as individuals move around an organization, as products and processes are revised, as customer, regulatory, competitor expectations change.
Information & Training presentations.
- Medical Device Validation, Regulation, Classification.
- Product and Process Validation.
- Quality Assurance, Quality Management Systems.
- SPC & Statistical Methods for Process Improvement.
- Risk Management.
- Lean & Just-In-Time Processes.
- Quality Management Tools & Techniques.
- Software Validation.
- Details >>>