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Mon, Jul 17

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TEAMS

cGMP Training SEP 2023

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cGMP Training SEP 2023
cGMP Training SEP 2023

Time & Location

Jul 17, 2023, 9:00 AM – 11:00 AM EDT

TEAMS

Training Program

Training Agenda

  1. Introduction to cGMP and Regulatory Landscape_ Overview of cGMP requirements and its significance in the Life Science industry Key regulatory agencies and their role in enforcing cGMP compliance
  2. Quality Systems and Documentation_ Understanding the essential components of a robust quality system Documentation requirements, including SOPs (Standard Operating Procedures), batch records, and validation protocols
  3. Facility and Equipment Considerations_ Good Facility Design (GFD) principles for maintaining a compliant manufacturing environment Equipment qualification and calibration best practices
  4. Materials Management and Control_ Supplier qualification and evaluation processes Proper handling, storage, and traceability of raw materials and finished products
  5. Process Validation and Control_ Introduction to process validation and its importance in ensuring product quality and consistency Control strategies for critical manufacturing processes
  6. Change Control and Deviation Management_ Change control procedures and the impact on cGMP compliance Handling and documentation of deviations and investigations
  7. Training and Personnel Qualification_ Training programs for maintaining a knowledgeable and skilled workforce Qualification and training requirements for personnel involved in cGMP operations
  8. Inspection Readiness and Post-Market Compliance_ Preparing for regulatory inspections and audits Post-market compliance considerations and surveillance activities
  9. Interactive Q&A Session_ Open discussion and clarification of specific questions or concerns related to your organization's compliance challenges

RSVP

  • cGMP Training

    This training aims to provide valuable insights and refresh your understanding of cGMP requirements, empowering your organization to maintain regulatory compliance and excel in quality and manufacturing processes. During this interactive training session, you will gain a comprehensive overview of cGMP guidelines and their practical application. The training session will also include an engaging Q&A session, allowing you to address specific questions and concerns related to your organization.

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