Regulatory Audit Preparedness
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Regulatory Audit training provides participants with valuable insights into effective preparation, execution, and response strategies. This comprehensive session covers the essential aspects of conducting successful audits and addresses the unique challenges posed by virtual audits in light of post-pandemic.
Regulatory Audit is an integral part of the medical device and pharmaceutical industry, where audit outcomes can significantly impact product approval and manufacturing operations. To ensure a favorable outcome, understanding the audit process and being equipped with the right resources, staff, and facilities are paramount.
The key to a successful regulatory audit lies in meticulous preparation and conducting the audit with utmost care. By focusing on strategic planning, appropriate staffing, and advanced preparations, you can greatly influence the outcome of the audit. This webinar delves into the crucial aspects of strategy, staffing, and proactive measures necessary to host a regulatory audit that yields positive results.
Areas Covered in the Session :
- Preparing for a third-party audit or inspection
- Assembly of an audit team
- Prestaging of documents and records
- Preparing “back room”
- Conducting the audit
- Required staff
- Opening meeting
- Tours
- Notes and communication
- Responding to audit findings
- Response team
- How fast
- Next steps
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Research and Development Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Scientists
- Everyone that supports during an audit
Course Director: Alan M. Golden
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Refund Policy
Cancellation by Registrant:
- Registrants may cancel their registration for any reason up to 2 business days prior to the event. A refund will be issued minus a $45 administrative fee.
- If a cancellation occurs after materials such as documents, handouts, checklists, slide deck, or recordings have been sent by Eventura, only 40% of the registration fee will be refunded.
- If the registrant fails to cancel within the stipulated time or does not attend the event, no refund will be issued. Options available to the registrant in such cases include:
- Access to a one-time recording of the event.
- A redeemable voucher.
Substitutions of attendees may be made at any time by notifying Eventura via email.
Cancellation by Eventura:
- Eventura reserves the right to cancel or reschedule an event due to insufficient registrations or unforeseen circumstances. Registrants will be notified via email prior to the event's start time unless prevented by situation beyond control.
- If an event is rescheduled, registrants will be promptly informed of the new date and their registration will be automatically transferred.
- If the new date is not suitable, registrants may choose from the following options:
- Access to a one-time recording of the webinar after the live session.
- A redeemable voucher valid for 12 months, applicable towards any future live event or past recording.
- A full refund will be issued if no new date is provided within 90 days from the originally scheduled event date.
If an event is permanently cancelled, registrants may opt for:
- A recording of the webinar, if available.
- A redeemable voucher.
- A full refund.
Eventura reserves the right to modify some topics, materials, or speakers/instructors without prior notice.
Refund Processing:
Refunds are processed within 7 business days from the receipt of the refund request. Eventura World is not liable for any penalties or expenses incurred due to an event's cancellation.
For additional information or clarification regarding our refund or cancellation policies, please contact our support team by phone or email us at support@eventura.us. Include your transaction ID, event ID, and event date in the subject of your email.