TRAINING MODULES

    VQI offers an array of courses covering different aspects of cGMP and GLP.


    Want to save time and money?

    VQI can conduct a customized version of any of these courses at
    your preferred location:


    Courses Offered (2008)


    Module #1:   Methods Development, Validation Procedures and
    Conformity Assessment in the Analytical Laboratory

    Abstract:  This course is designed with a fundamental grass roots approach to
    understanding measurement uncertainty and approaches validation in a very
    generic style.

    The presentation aims at understanding basic elements of an analytical
    method both from the Quality Systems perspectives and with the more
    fundamental approach of measurement, errors and uncertainties in the
    analytical measurement process in particular.

    A goal-oriented method development will be introduced with a generic,
    iterative and modular approach to understand validation in general at the
    same time establishing the capabilities of the analytical method as the method
    is being developed.  The various stages of scoping out the method initially
    followed by an informed strategy of design, development and optimization to
    arrive at the validation parameters will be presented elaborately and lucidly.

    The guidances from USP, ICH, AOAC and other international standards will
    be discussed.

    Group exercise and case studies with real examples are integral parts of the
    presentation.

    This very structured presentation continually builds on data handling,
    documentation and regulatory requirements for regulatory compliance issues.  
    There is extensive guidance provided during the course for preparing validation
    protocols for various stages of IND, NDA and laboratory control, QA, QC inside
    companies.  A brief discussion on statistical tools, SQC, SPC and stability
    indicating assays are included.


    Module #2:    Qualification and Validation of Lab Systems and
    Validation in the Pharmaceutical Laboratory (IQ,OQ,PQ)

    Abstract:  This course gives a conceptual background of the qualification
    and validation of various instruments, apparatus, devices, systems and
    equipment from a risk assessment and product lifecycle perspective with
    several examples, specifications, protocols and SOP requirements at
    various stages of deployment and use of various equipment, instruments,
    etc.  It scopes out the requirements testing and acceptance criteria to calibrate,
    standardize or validate as appropriate various laboratory equipment/plant/
    process equipment/devices/gadgets/recorders/on line monitors/meters/micro
    devices (e.g. HPLC, GC, MS, Dissolution apparatus/blenders/mixers/stability
    chambers/autoclaves 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 PVP, validation protocols, SOP’s, charts, forms, data sheets,
    etc., with global guidelines discussions from a risk assessment (ICH Q9, ASTM,
    ISO) approach.


    Module #3:   Cleaning Validation and Compliance Issues For Pharma,
    Biotech and Medical Device Industries

    Abstract:  This course is an intermediate level course designed for Q.C.
    Management, Analytical, Production, Process Engineering, Maintenance
    Supervisors and other plant personnel engaged in the plant and production
    equipment.  It will help to scope out the effectiveness of cleaning procedures
    in the various matrix of drug products in the streams of processing and
    manufacturing.  It covers detailed treatment of residues, different techniques
    of sampling, and the applicable microbiological and analytical procedures
    used to support Cleaning Validation and their verification.  A major focus in this
    presentation is to develop a risk assessment strategy for scoping out Cleaning
    Validation inside Pharmaceutical, Biotech and Device Companies.

    The dynamics of interaction between various groups and functions in the
    Cleaning Validation Team is a key factor in the management of Cleaning
    Validation.  The discussions will include effective training and documentation
    for a successful program.


    Module #4:  Good Distribution Practices (GDP) & Directives: EU/WHO

    Abstract:  This 2-day course will cover the various aspects of supply chain
    integrity as scoped out in the European GMPs and will provide a compre-
    hensive overview of Good Distribution Practice and the Quality Systems
    and procedures necessary to ensure compliance with the directive.  Some
    of the issues related to the handling and global distribution of drug products,
    including the requirements and guidance from the EU, EMEA, WHO directives
    and other sources, will be discussed.  Also, general preparedness,
    documentation, quality assurance, counterfeit concerns, and handling of
    emergency situations (FDA directives) on Product Recall will be addressed
    as well.  Case studies and real-life examples on the vulnerability of supply
    chain will be included.


    Module #5: Process Analytical Technology (PAT)

    Abstract:  This presentation will introduce some of the recent initiatives and
    directives from US FDA as well as the genesis, scope, relevance and
    applications of PAT framework.  Some basic understanding of process
    measurement, process optimization and control, impact of micro sensors
    and online monitoring tools will be provided.  Some examples of micro analytical
    techniques in process control and validation will be included.

    The FDA PAT directives and the scope will be discussed with relevance the
    framework of PAT implementation.  Guidance from recent ICH Guidelines
    (ICH Q8, Q9, Q10, etc.) and other sources are included.

    Discussion will include, with examples, the various analytical techniques
    including NIR, Raman, Acoustics, GC, HPLC that are finding more and more
    applications in At line, On line measurements at various stages of production
    and processing.

    The applications of various statistical tools, SQC, SPC and DOE, have various
    applications in PAT and will be covered.

    The management of PAT initiatives and applications inside companies remains
    a challenge, and the discussions will include the dynamics related to such activities.


    Module #6:  The Qualified Person (QP) - Relevance, Role, Responsibilities
    and Requirements in the Regulated Industries/Quality Systems

    Abstract:  This highly informative two-day presentation will aim at outlining and
    highlighting the roles and responsibilities of the QP in medicinal products for
    the areas of manufacturing, holding, and distribution, with emphasis on legal
    obligations.

    The guidance from EMEA on the roles and responsibilities at various stages
    of product development will be discussed with relevance to the documentation
    strategies and other requirements.

    Discussions will include the scoping out and development of the Quality
    Agreement and other relevant documents to satisfy the requirements.  
    Comparison with WHO and other global standards will be included.
    .

    Module #7:  Trends and Highlights of Global Compliance Issues -
    Risk Management Approach

    Abstract: This 2-day presentation will aim at providing highlights of current
    Regulatory Compliance issues with particular reference to US FDA, EMEA,
    WHO, Canadian GMP’s and other international guidelines.  International
    harmonization initiatives, including the ICH, OECD, HAS, etc., will be discussed.

    Perspectives of inspection and audit issues with a systems-based inspection
    approach and preparation within a company with risk assessment and
    mitigation strategies will be discussed.


    Module #8:  Study Director, QAU & Management: Roles and
    Responsibilities in the GLPs (FDA/OECD)

    Abstract:  This 2-day presentation aims at highlighting the roles,
    responsibilities and duties of key Management, Supervisors, Scientists,
    Principal Investigators, Regulatory, QAU and other personnel in GLP
    facilities, contract laboratories, research institutes, CRO’s or other
    organizations engaged in the conduct of GLP (FDA, FIFRA, OECD, JAPAN,
    etc.) studies and other non-clinical studies related to drug development,
    safety & toxicity studies and various targeted evaluations.  Discussions will
    include the various aspects of Study Conduct, QAU audits, Protocol
    development, and the roles of Study Directors, Management, PI’s, QAU and
    other key personnel with real life examples, case histories, group participations
    and class assignments.  The basic tenets of FDA and OECD or other GLP’s
    will be covered with comparison on some key issues.  The course is geared
    towards the development of understanding the basic requirements and key
    compliance issues with a Risk Assessment and QS based approach at
    various levels of Management and organization in a compliant GLP Testing
    Facility.


    Module #9:  Pharmaceutical Development, Process Optimization
    and QA/QC Validation Issues

    Abstract:  This two-day presentation will cover the various stages of
    pharmaceuticals product development with a major emphasis on the
    process development, optimization and validation issues.  The framework
    of product development and guidances from the international standards
    on CGMP, ICH Q7, Q8 with a risk-based approach (ICH Q9 ) will be discussed.

    Methodologies used in support of process development and optimization will be
    discussed.  The development of Protocols and Product Development Reports
    will be included.

    Case studies and group exercises will be included.


    Module #10:  Integration of ICH Directives for cGMP

    [under construction]


    Module #11: QA/QC & Validation Issues in the Water Analysis Laboratory

    Abstract:  This two-day short course will address some of the QC/QA related
    activities in laboratories engaged in various testing and analysis of water
    compliance to AWWA, EPA, USP and other domestic and international regulatory
    standards.  Development and validation of analytical, microbiological and other test
    procedures requirements will be included.

    The applications of various statistical tools in QA/QC activities within the frame-
    work of a high thruput laboratory will be discussed.

    The various analytical methods and other test procedures routinely run in the
    water analysis laboratories and their validation requirements will be discussed
    with select examples.  The significance of various validation parameters,
    including accuracy, precision, robustness, reproducibility, LOD, LOQ, etc., will
    be discussed.  The documentation strategies for regulatory compliance to
    various standards will be discussed.


    Module #12:  FDA Enforcement Actions, Deviations & CAPA System

    Abstract:  This two-day presentation will cover some of the roles of CAPA
    systems, their scoping out and focus.  The feedback from CAPA to support
    the Quality Management in manufacturing, production and CRO operations
    will be discussed with examples.  The investigations of OOS/OOT results
    and customer complaints vis-à-vis of other sources will be discussed with
    the examples of various quality tools, including Root Cause Analysis and
    Pareto charts with a comprehensive risk assessment and quality systems
    based  approach in GMP/GLP facilities, CRO’s, and other organizations.  
    Examples of Deviations, FDA 483’s and Warning Letters will be included.  
    CAPA plays a major role in the Quality Systems implementation with a risk-
    based approach.  The discussions will cover aspects of Risk Assessment
    and Quality Systems with excerpts and guidance from ICH Q9, ICH Q10,
    ISO 73 and other global standards.

    Maintaining a robust CAPA system is a major effort inside a company.  
    The documentation strategies, and the dynamics of input and interactions
    between the various functions in a company, will be included in the
    discussions.

    Examples and case studies will be included with group interactions.
    .





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Contact Us

               

Dr. Shib Mookherjea
ValQual International
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Saint Cloud, FL  34769

or

ValQual International
P.O. Box 170
Florham Park, NJ  07932

Phone: 201-615-6346
Fax: 407-498-2027

email:
info@valqualintl.com

Administrative Manager
Wendi Petrone
Fax: 864-963-7899
email:
wpetrone@valqualintl.com