Regulatory issues for regulated industries
- Management of external audits.
- Management of documentation systems.
- Deviation management and CAPAS.
- Development and maintenance of work orders.
- Importance of organizational structure, training matrices and job descriptions.
- Establishing a strong quality system.
- Good practices in conducting investigations and corrective and preventive actions.
- FDA, DEA, CMS regulations (according to industry and customer needs).
- Legal Impact of what we document and how we document it.
Administrative and legal matters
- Legal and regulatory project management (applied to client's industry).
- Build effective contracts to manage your business relationships (suppliers, business partners and staff).
- Strategies for handling management stress situations caused by organizational or legal conflicts.
- Strategies for handling management stress situations caused by organizational or legal conflicts.
- Minimizing risks in an organization.
- Protocol for dealing with domestic violence.
- COVID Exposure Control Plan (as required by PROSHA to operate with on-site employees).
- Fair Labor Standards Act: Requirements and Exemptions for Executives, Managers and Professionals.
- Employee or Independent Contractor?
- Legal Project Management.
- Techniques for proper management of an operating budget - for NPOs.
- Techniques for effective time management.
- Strategic planning.
- Corporate policies.
- Duties of a Board of Directors in an NPO - roles, responsibilities and exposure.
- Eficiency in daily operations.
Training