GMP Validation Workshop | Learn to create your own workshop and private sessions
Dr. Richard Poser, President, First Quality Inc
Coming soon.. Please contact customer care for new schedule
Validation of laboratory systems, manufacturing facilities, manufacturing equipment, computer systems and analytical test methods may be nice to have in some businesses, but is an essential regulatory requirement for regulated companies.
This workshop is designed to give attendees basic training in the principles and practices of validation, using your own systems as examples in our workshops of what to do, what not to do and how to document validation for inspection.
In this two day workshop conference:
- You will learn the different global agencies expectations of validation for pharmaceutical manufacturers or contract organizations supporting GMP/GLP/GCP operations
- We will focus primarily on drugs and devices, and will tailor the course to the specific needs of the attendees using case studies from both our own and attendees experience (within limits of confidentiality)
- You will earn the underlying regulations and the current industry practices for risk-based validation, with take-away lessons and learning you can apply to be more efficient and effective back on the job
- We will make available workshop materials including templates for various types of validations, and complete several in-session using real-life working examples
- We will facilitate both public and private review sessions where confidentiality must be maintained
- Upon registration attendees will receive some advance conference materials to gather information to use in their own workshop and private sessions.
Upon completing this course participants should:
- Know the domestic and foreign regulations requiring validation
- Understand the principles of validation
- Be able to design a risk-based validation plan which can significantly reduce validation effort and documentation
- Understand the relationship between specifications and verifications
- Know which validation documents are critical for inspection
- Design a validation plan and qualification protocols for their own systems
- Be able to effectively present validation documentation for inspection
Who will Benefit:
This course is designed for people responsible for the validation of equipment, facilities, computer systems and test methods used in GMP facilities. This includes the end users, scientists, chemists, engineers, quality assurance and system administrators working in drug, device, pharmaceutical companies, as well as their counterparts in contract research, contract manufacturing and contract analytical testing organizations.
Following personnel will benefit from the course:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- Design engineers
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
- Quality Control chemists
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
|Day 1 (8:30 AM – 4:30 PM)
||Day 2 (8:30 AM – 4:30 PM)
- 8:30 – 9:00 AM: Registration
- 9:00 AM: Session Start Time
- Attendees goals for the conference
- setting priorities
- Areas of emphasis for conference and workshop
- Regulations requiring validation
- EMA, EU
- Principles of Validation
- The V-Model
- Validation documentation
- URS, FRS, SDS
- IQ, OQ, PQ, UAT
- Computer Systems Validation
- Enterprise applications
- Electronic Document Management
- Clinical data systems
- Manufacturing controls
- Environmental monitoring
- Case studies
- Facility Qualification and Validation
- Relationship of commissioning, qualification and validation
- ISPE guidance
- Case studies
- Risk-based equipment qualification and validation
- Use of vendor documentation vs. custom scripting
- Analytical test method validation
- Data acquisition and LIMS integration
Meet Your Instructor
||Dr. Richard Poser
President, First Quality Inc.
Dr. Richard Poser has been both receiving and conducting audits in drug, laboratory, device, software and manufacturing environments for over 25 years and teaches from personal experience. He has been Director of Laboratories in both R&D, clinical phase and commercial operations in drugs and medical devices, and has been a consulting quality systems advisor or auditor to dozens of diagnostic, biologics, pharmaceutical and medical device manufacturers including many of the Fortune 500. Following many inspections he has been retained to design remediation and corrective actions to attain regulatory compliance. Dr. Poser is President and Lead Auditor for First Quality Inc., a consulting firm which has conducted hundreds of 3 rd -Party audits for laboratories, data systems and manufacturing operations. He has special expertise in data systems and 21CFR Part 11 compliance, and has worked with dozens of companies to validate systems used in regulated laboratories.
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If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Palo Alto, CA 94303
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