Faculty: Charles H. Paul ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3667


  • Date: 7/16/2024 11:00 AM - 7/16/2024 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event

 

Description

This webinar is designed exclusively for life sciences contract manufacturers. Gain a comprehensive grasp of business continuity planning tailored to your industry. Explore crucial elements such as risk assessment, emergency response, communication strategies, and recovery plans. Identify vulnerabilities, analyze disruptions, and implement effective risk mitigation strategies with real-world case studies.

Learn the step-by-step process of building a business continuity plan, from forming cross-functional teams to conducting thorough risk assessments and business impact analyses. Set recovery objectives, establish emergency response protocols, and create communication strategies. Emphasize plan review and updates to address emerging challenges.

Navigate regulatory compliance and audits with insights into industry-specific requirements. Discover compliance frameworks, perform internal audits, and prepare for regulatory inspections. Our webinar includes a Q&A session for expert guidance on your business continuity planning.

Elevate your understanding of business continuity planning, mitigate risks, and ensure operational resilience. Join us to safeguard your critical functions against disruptions.

Why You Should Attend:

  • Gain Essential Knowledge: This training offers a tailored overview of business continuity planning for life sciences contract manufacturers. Participants will grasp the core components of a robust plan, including risk assessment, emergency response, communication, and recovery strategies.
  • Enhance Preparedness: Attendees will learn to identify risks and vulnerabilities within contract manufacturing operations, effectively mitigate disruptions, and develop comprehensive business continuity plans. This preparation ensures minimal disruption impact and the continuity of critical functions.
  • Stay Compliant with Regulations: Contract manufacturers in the life sciences sector must adhere to specific regulations. This training covers compliance considerations, including frameworks, internal audits, and preparation for regulatory inspections. Staying compliant safeguards against penalties and maintains trust.
  • Learn from Case Studies and Best Practices: Dive into case studies and industry scenarios to uncover challenges faced by life sciences contract manufacturers. Learn from best practices and lessons learned in business continuity planning, gaining practical insights for improved preparedness and resilience.

Areas Covered in the Session :

  • Introduction
    • Brief overview of contract manufacturing in the life sciences industry
    • Importance of business continuity planning for contract manufacturers
  • Understanding Business Continuity Planning
    • Definition and purpose of business continuity planning
    • Key components of a robust business continuity plan
      • Risk assessment and impact analysis
      • Business impact analysis (BIA)
      • Emergency response and crisis management
      • Communication strategies
      • Recovery strategies and contingency planning
    • Regulatory considerations for contract manufacturers in life sciences
  • Assessing Risks and Vulnerabilities
    • Identifying potential risks and threats in contract manufacturing
    • Analyzing the impact of disruptions on business operations
    • Supply chain vulnerabilities and risk mitigation strategies
    • Case studies highlighting real-life scenarios and lessons learned
  • Developing a Business Continuity Plan
    • Establishing a cross-functional business continuity team
    • Conducting a comprehensive risk assessment and BIA
    • Setting recovery objectives and prioritizing critical functions
    • Designing a robust emergency response plan
    • Implementing effective communication strategies
    • Developing and testing recovery strategies
    • Documenting and updating the business continuity plan
  • Best Practices for Business Continuity in Contract Manufacturing
    • Building resilience in the supply chain
    • Establishing backup manufacturing and redundancy options
    • Collaborating with suppliers and partners for continuity
    • Maintaining data backup and recovery systems
    • Training employees for emergency response and business continuity
    • Regularly reviewing and updating the business continuity plan
  • Regulatory Compliance and Auditing
    • Understanding regulatory requirements for business continuity planning
    • Compliance frameworks and guidelines for contract manufacturers
    • Conducting internal audits and self-assessments
    • Preparing for regulatory inspections and audits
  • Case Studies and Lessons Learned
    • Examining case studies of contract manufacturers in the life sciences industry
    • Analyzing the challenges faced and strategies implemented
    • Lessons learned and key takeaways

Who Should Attend:

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Supply Chain Management
  • Emergency Response/Crisis Management
  • Compliance Departments

Course Director: CHARLES H. PAUL 

 

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.