Regulatory Inspections and Quality Audits

This course will focus on Regulatory Inspections and Quality Audits. It will cover Health Authority inspections as well as internal Quality Audits and also managing corrective action plans that can result from audits.

Why Should You Attend:

Regulatory Inspections and Quality Audits are something every Pharmaceutical and Biotech company should be familiar with. These can be inspections conducted by Health Authorities, such as the US Food and Drug Administration, or they can be audits the company does internally to either prepare for a Health Authority inspection, or just to ensure proper operations at their manufacturing sites. This course will cover the basics for both of these types of inspections and audits, including giving companies basics to be prepared for both the inspection/audit and the outcomes.

• Gain a better understanding of Inspections by Health Authorities
• Better understand reasons for conducting internal voluntary audits
• Understand the importance of Health Authority Communications with regard to Inspections
• Understand the roles of Regulatory, Quality Assurance, CMC and Manufacturing play in Inspections and Audits
• Better understand the outcomes of Inspections and Audits and what companies next steps should be in dealing with them

Areas Covered in the Webinar:

• FDA Audits/Inspections
• Other Health Authority Audits
• Pre-Inspection/Audit Preparation
• Internal Roles during an Inspection/Audit
• Dealing with the aftermath of Health Authority Inspections
• The 483 Form
• Internal Audit results and how to handle them
• Reporting requirements for internal audits

Who Will Benefit:

Regulatory Affairs, Quality Assurance, CMC, Manufacturing

From

• Pharmaceutical Industry

Why Should You Attend:

This webcast will focus on the continued uncertainty and anxiety of COVID-19 and provide information to employers on how to protect employees, visitors, vendors and contractors of COVID-19 as they return to work. You should attend this jam-packed informational webinar to gain a better understanding of what a Return-To-Work Procedure entails and best practices to implement for a smooth transition back into the workplace.

Employers and employees who participate in this webinar will obtain a better understanding of the applicable OSHA regulatory requirements that have been eased up during this time and those that have not.

You should attend this jam-packed informational webinar to gain a better understanding of what a Return-To-Work Procedure entails and best practices to implement for a smooth transition back into the workplace.

Areas Covered in the Webinar:

• Elements of an COVID-19 Return-To-Work Procedure.
• Applicable OSHA regulations to COVID-19 such as Recording and Recordkeeping on OSHA Log, training, etc.
• What and how to and what not to do for Pre-shift health screening protocols and best practices such as temperature monitoring and symptom questionnaires.
• Plant Wide Risk Matrix - Engineering, Operational Controls and PPE to minimize panic in the workplace.
• How to implement effective engineering and administrative controls to mitigate potential exposures to COVID-19 in the workplace.
• Preventative Measures and Best Practices to prevent COVID-19 in the workplace.

Who Will Benefit:

Supervisors, Managers, and Leaders of businesses/government agencies of all kinds.

• Employees
• Business travelers
• Healthcare Professionals
• Dental care Professionals
• Laboratories
• Airline operations
• Border protection
• Solid waste and wastewater management
• Managers
• Supervisors
• Contractors
• Small sized business owners
• Medium sized business owners
• Large sized business owners
• Safety Managers
• HR Managers
• Plant Managers
• Operations Managers
• Safety Committee Members
• Safety Consultants
• Any public or private company in general, maritime, construction or agricultural industries, basically for You and for Everyone.
• All industries - non-profits - associations and employees of government agencies.