There are big challenges facing those responsible for chemical regulatory compliance. An expansion of the number and diversity of REACH-like regulations, competing deadlines, as well as changes in company structure, supply chains and the geopolitical landscape, has meant it is ever-more important to stay on top of regulatory changes.
This course will use the key principles of an Integrated Management System (Management of change & the PLAN, DO, CHECK, ACT model) to help equip you and your organisation to implement continual improvement and manage your compliance obligations.
As well as exploring how to take a proactive and integrated approach to chemical compliance, the course provides practical information on REACH-like regulations (including the EU, UK, India, Korea, Turkey, China, South-East Asia, the US and Canada). We will also cover tools and resources to increase efficiencies.
At a glance
Here is a summary of what you can expect from this course.
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2 day in-person classroom
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Practical exercises to put your knowledge into practice
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Interaction with our expert
When and where?
Scroll down to see the map and the route options
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Äußere Nürnberger Straße 62 91301 Forchheim
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April 9-10, 2024 9:30-16:00
Who should attend?
This workshop will be most relevant to:
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Exporters of chemical products to global markets
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Companies with subsidiaries manufacturing or importing chemicals
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Regulatory managers and specialists
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New starters to the company
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Downstream users of chemicals
Topics to be covered during this classroom
PLAN
- A company-wide approach to address compliance - strengths and challenges
- Overview and direction of key chemical regulations across the world
- Global regulatory deadlines - create your own GANTT chart
- Mapping your regulatory obligations
- Resources
- Information sources for regulatory updates
- Financial resources and budgeting
- Human resources (internal and external)
DO
- Preliminary work:
- Checking your substances are in scope!
- Preparing lists of products, substances, tonnages and actions for each country
- Software systems to manage product information
- Service and testing providers
- Exemption confirmation and reduced requirements (incl. polymers)
- Data requirements (analytical and toxicology)
- Case study: data sharing/use of existing REACH registration data
- Delivery:
- In-country legal representation (including OR / TPR appointment)
- Pre-registration and inventory nominations
- Registration dossier and risk assessment preparation
- Maintaining compliance post-registration
- Record-keeping and Reporting
- This section introduces, compares and contrasts high-level themes (such as data sharing) across different chemical notification systems. In addition, to develop a more detailed understanding of each regulation, regulatory factsheets are provided to all attendees.
CHECK
- Monitoring regulatory changes:
- Software systems and tools
- Regulatory authorities
- Conferences and training
- Industry associations
- Newsletters
- Management of change - planned or new developments, new or modified activities and products
- Organisational processes, responsibilities, communication and records
- Audits - planning, conducting, reporting audit findings
- Inspections:
- What to expect
- How to prepare
- Penalties and prosecutions
- Evaluating and managing the risk of non-compliance
ACT
- Responding to improvements or non-compliances identified from audits or inspections
- Corrective actions and root-cause analysis
- System-level strategies to prevent future non-compliances and improve on existing practices
Learning Outcomes
At the end of the classroom, participants will understand
- Understand the key regulatory developments on the horizon
- Compare and contrast the different requirements of global REACH-like regulations
- Plan and prepare a compliance strategy
- Identify practical tools and resources to assess and monitor the regulatory status of chemicals and products
- Describe how to integrate chemical compliance into the organisation via the PDCA and change management models
Join us for this interactive in-person classroom
How to get to the training venue?
This in-person classroom will take place in Medical Valley Center Forchheim where Yordas' Germany office is located.
Instructors
Join our leading scientific and regulatory experts in this interactive workshop
Sophie Guinard
Senior Regulatory Consultant
Ines Zitterbart
Senior Regulatory Consultant