SME development and mentoring
What it is – The development of a true Subject Matter Expert (SME) takes time and experience. Our SME Mentoring Programme is designed to reduce that time by the application of a structured four stage CORE development programme. This programme delivers knowledge transfer through training, coaching and mentoring. Using the CORE principles. The Compliance Group/Compliance Management provides both the methodology and the tools with which the SME can develop and hone their core competencies. Providing much more than just advice, this programme focuses on delivering pertinent feedback with practical examples from qualified professionals in the field.
Who uses it – System Owner, Subject Matter Experts (may be worth adding some specific examples )
training
What it is – GXP Training was set up in 2016 to harness the expertise within The Compliance Group/Compliance Management and their wider network to develop and deliver a suite of training courses in the GxP environment.
As well as providing professional and focus scheduled courses that will provided cost effective ways to meet training needs within the industry, all courses will be available for in-house training. Courses can be customised to meet the needs of our customers. If you would like further information on our training courses, you can find them on www.gxp.ie. If the course you require is not available please email your query to training@gxp.ie.
A training certificate will be provided to each participant following successful completion of training assessment.
Who uses it – Departmental Manager, Training Manager, Quality Manager
storyboard preparation and review
What it is – Storyboards are used by SMEs in the most successful manufacturing companies to give a summary of a process, procedure, or event which a GMP Inspector wishes to review. We coach SMEs in the design, delivery and practice of Storyboards to increase SME confidence and optimise the probability of success in an inspection
Who uses it – System Owner, Subject Matter Experts
site leadership advisory services (SLAS)
What it is – Site Leadership have core roles in Quality Compliance and defined responsibilities in the GMPs which can be applied in a complex range of technical platforms. The awareness of their responsibilities and confidence in governing and guiding compliance can be augmented by the SLAS. Our consultants can act as trusted advisors to site leadership to provide experienced and balanced advice.
This service provides holistic pertinent training in the GMPs including regulatory changes and trends. It can help ensure the site systems and metrics provide a transparent and holistic evaluation of compliance risks and priorities and help you ask the right questions of the your management/leadership teams. SLAS can also be used to discuss interpretation of specific regulatory requirements or strategic approaches.
Who uses it – New or transitioning Leaders, Site Leads or Heads of Department that require support with specific technical GMP knowledge
qualified persons
What it is – Our team of Qualified Persons have expertise and flexibility required to fit with your requirements and to deliver support when, where and how you need it. Qualified Persons can be used on an as-needed basis to give you an efficient and cost-effective solution for your batch disposition requirements.
While some larger companies have the luxury of having several QP’s on the licence, not all companies are in such a position to do so, causing difficulties for the facility to operate during periods of QP absence, and periods of intensive demand such as project management.
Our expertise in this field is second to none and provides you with the equivalent level of confidence that an in-house department can provide. Consider us an extension of your facility!
Who uses it – Quality Manager/Quality Director
responsible persons
What it is – The status of our Qualified Persons comfortably makes them eligible to act as a Responsible Person for your Wholesaler’s Authorisation. Our QP’s have the level of expertise and degree of flexibility required to fit with your requirements and to deliver on them when, where and how you need them.
Our QP’s can act as your primary or deputy RP depending on your needs to ensure your company continues to operate during periods of RP absence, and periods of intensive demand such as project management.
Who uses it – Quality Manager/Site Director
audits
What it is – Audit is an increasing requirement being placed on the pharmaceutical industry for those in manufacturing and distribution of medicinal products. Traditionally the audit requirement has extended to Contract Manufacturing Organisations and Contract Laboratories, but the obligations are extending to Distributors of the Finished Product and Manufacturers and Distributors of Active Pharmaceutical Ingredients (APIs). In some cases, even excipients carry the requirement for auditing. It is also common for the audit function to be applied to emerging areas of Regulatory Concern such as Marketing Authorisation Holders, Packaging Suppliers, etc.
Our experienced group of QP’s and Auditors are uniquely placed to meet your audit needs with focus on the following deliverables;
- Quality expertise
- Regulatory expertise
- Efficiency
- Risk-based focus
- Technical expertise
Who uses it – Quality Manager/Quality Director, Global Quality
due diligence
We are available to provide due diligence assessments for companies seeking to acquire a pharmaceutical / pharmaceutically related company. The unusual nature of the due diligence rules of engagement mean that we can quickly verify likely compliance or identify potential areas of concern.
process flow video
Facility layouts and process flows can be difficult to describe in a manner that delivers technical content, elegance of the facility and the process flow. Our Point-of-View process flow video efficiently captures your production system and presents it in a way that describes the process, and is visually appealing.
The Compliance Group in association with Lensmen have joined forces to produce a high calibre video of a company’s facilities, which can be used in opening presentations to GMP/GDP Inspections, to Visitors and in other promotional activities.
