Process and Cleaning Validation Workshop

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Date Jul 12, 2018
Time 10:30 AM EDT
Cost $20000
This interactive 2 day Live In Person seminar on Process and Cleaning Validation, utilizes the: – Product and process Realization using current cGMP requirements, Concepts and Principles of – Product and process Realization using Quality by Design, Risk based approach with Illustrative Example as the basis for explaining and providing examples of how products and processes can be validated, using QRM with special emphasis on the considerations for implementing these processes in manufacturing with respect to Formulation and API.

Participants will leave the workshop with a greater understanding of:
  • Cleaning Validation Concepts
    • Introduction of relevant Guidelines
    • CV Concepts and how to do residue and MACO calculation
    • CV Risk Management
    • CV Plan-Cleaning validation protocol
    • CV Report-cleaning validation report
    • CV Revalidation, CV Verification
    • Typical inspection findings, warning letters
  • Special Aspects of Cleaning Validation Acceptance criteria
    • Cleaning methods: CIP, WIP, manual cleaning
    • Random Controls and Hold time studies: DHT, CHT
    • Validation of analytical methods used for CV
  • Organisation and Planning Process Validation, Packaging operation validation and its documentation
  • Equipment Qualification and its approach and regulatory requirements and documentation
  • Analyst and personnel Validation
  • Transport validation and its verification
A must attend seminar for professionals in Pharmaceuticals, QC Laboratories, Manufacturers of drug substances (APIs), Oral Solid Dosage Form, Contract Laboratories, Clinical research Organizations, Contract Research Organisations, Contract Manufacturing Organisations and Biopharma companies.
– Quality Control
– Quality Assurance
– Research and Development
– Manufacturing
– Engineering
– Analytical Development Laboratories
– Regulatory Compliance
– Validation
– Production
– Technology Transfer
– Laboratory
– Documentation
– Training Departments

– Managers
– Supervisors
– Senior Managers
– Team Leaders
– Executives and Senior Executives
– General Managers
– Engineers
– Design Engineers
– Plant Managers
– Laboratory Managers and Supervisors
– Regulatory Affairs Managers
– Documentation Specialists & Analysts
– Internal and External Auditors


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