Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices, etc.)

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. The two day sessions will include a class breakout session (2.5 hours) for each of the 2 Days (in the afternoon), wherein the attendees will be given a group exercise topic relevant to the material, in practical demonstration of meeting FDA/EMA/WHO/ICH compliance requirements. These brainstorming, highly interactive sessions are useful to attendees in gaining practical knowledge, along with the comprehension of the subject matter.

Various instruments and Systems are routinely used for R&D, QC and product development activities. In order to meet regulatory compliance, cGMP, GLP, ISO13845, WHO, EMEA, etc. all such equipment need to go through various levels of Calibration, Standardization, Qualifications and Validation depending on the complexity and their intended use. In contrast to Methods Validation, the area of Analytical Instrument Qualification (AIQ) has only limited specific International guidance.

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 attendee 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. It scopes out the requirements testing and acceptance criteria to calibrate, standardize and/or validate as appropriate for the various equipment and systems. The same rationale that applies to laboratory equipment, could be extended to plant, process and manufacturing equipment, devices/gadgets, recorders, online monitors/meters/micro devices (e.g. HPLC, GC, MS, Dissolution Apparatus/blenders/mixers/Stability Chambers/auto-claves or common Instruments, meters and devices) in plant, production micro labs, aseptic areas and processing departments throughout various functions in the cGMP facilities. Examples are discussed with acceptance criteria, particularly with lab systems and their QC/QA perspectives. The regulatory aspects and global guidelines will be discussed with documentation strategies, including a Master Validation Plan doc, enumeration of Validation Protocols, SOP's, charts, forms, data sheets, etc., with global guidelines discussions from a risk assessment (ICH Q9, ASTM, ISO) approach.Format and Style

Each Training session is presented with the ultimate goal of providing understanding and comprehension of the basic concepts and applications relevant to the topic. Most of the topics embrace applications of scientific principles with highly complex technological applications and therefore, the level of comprehension is intense. To achieve effective knowledge sharing, the attendees are encouraged to participate during the presentation. As a result, the style of presentation is highly interactive and participative.

A 2.5 hour Group exercise is included for the attendees in the afternoon sessions on both of the days. A task will be discussed and depending on the size of the class, small groups of attendees will work on the assignment to come up with developing a strategy and Protocol for various Systems at the various stages of Installation Qualification(IQ ), Operational Qualification (OQ), Performance Qualification (PQ ) of a chosen Analytical system, and the common task of developing the schematics of a compliance friendly Master Validation Plan.

Why should you attend:

This is an area of growing concern, sometimes ridden with uncertainty as to what needs to be done at each of stages of the Product Lifecycle. In modern Pharmaceutical and Biotech laboratories, a composite array of various gadgets, devices, analytical instruments and computerized systems are used daily. This Seminar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.

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 will benefit:

• Scientists
• Managers
• R&D Personnel
• Quality Assurance / Quality Control Staff
• Validation Managers
• Validation Coordinators
• Production and Process Development Personnel
• Regulatory/Compliance Managers
• Chemists
• Technicians Study Directors(GLP)
• Qualified Persons (EMEA)
• Pharmaceutical Development
• CRO Staff
• CRO Managers
• Accredited Laboratories in general
• any one engaged with Test Methods