$1,300 – $1,600

Qualification and Validation of Laboratory Equipment and Systems for Regula...

Event Information

Share this event

Date and Time

Location

Location

(Venue to be announced shortly)

San Diego, CA

View Map

Refund Policy

Refund Policy

Refunds up to 7 days before event

Event description

Description

This Seminar will address requirements of both Validation and Qualification activities in Pharma, Biotech and Device Industries, both for compliance to Regulations and industry specific guidelines. More particularly, with respect to Validation of Systems, it will introduce and enumerate a grass roots, basic, iterative pathway to Qualification (IQ, OQ, PQ) of Laboratory Equipment and Validation, which is very portable and widely applicable across the industries. A brief discussion on Qualification of various laboratory instruments and systems will also be touched upon, including current guidance from USP on Analytical Instrument Qualification processes. This Seminar will cover, with illustrations and examples, the various stages in Validation and Qualification of Laboratory Equipment and Systems with a Risk Based Strategy.

Why You Should Attend:

This 2-day Seminar is highly informative and descriptive of the IOPQ Process and what needs to be done for verification of the operational, functional and performance of such equipment and systems. During the Seminar, the attendees will be given a conceptual background of the Qualification and Validation of various instruments, apparatus, devices, computerized systems and equipment from a risk assessment and Product Life Cycle perspective, with several examples, specifications, protocols and SOP requirement stages of deployment and use of various equipment, instruments, etc.

Areas Covered in the Session:

  • Qualification and Validation in Regulated laboratories
  • Examples of Regulatory Enforcement Actions
  • Risk Based Strategy
  • Product Life Cycle and sharing of responsibilities between Vendor and the User
  • Integration with Quality System
  • Master Validation Plan
  • Group Exercise: Develop Qualification Strategy and Master Validation Plan
  • Examples of select Equipment /Systems
  • Training Issues
  • Discussion on guidance from USP on analytical instrument qualification
  • Discussion on testing and acceptance criteria

Who Should Attend:

  • Research and Development Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Validation Departments
  • Production Departments
  • Process Development Personnel
  • Regulatory Departments
  • Compliance Departments
  • Scientists and Chemists
  • Technicians Study Directors (GLP)
  • Qualified Persons (EMEA)
  • Pharmaceutical Development
  • CRO Directors and Managers
  • Accredited Laboratories in general
  • Everyone engaged with Test Methods
Share with friends

Date and Time

Location

(Venue to be announced shortly)

San Diego, CA

View Map

Refund Policy

Refunds up to 7 days before event

Save This Event

Event Saved