Technical Report Writing and Statistical Analysis for the Pharmaceutical Industry


2-Day In-Person Seminar (Code – INDSEM118)

Technical Report Writing and Statistical Analysis for
the Pharmaceutical Industry


    DR. MARK POWELL
             Mark Powell Scientific Limited
 

    December 6 – 7, 2018

    Mumbai, MH, India

Seminar DescriptionAgendaSpeakerPricingVenue
Clear, unambiguous technical reports and procedures are of vital importance in the pharmaceutical industry. They are used to communicate the outcomes of product development work and investigations, and may be reviewed by the FDA, or other regulatory bodies, if they form part of a regulatory submission. On this course, participants will learn how to analyze and present technical data in a clear and concise manner. They will produce powerful charts and graphs using the graphics tools in Microsoft Excel® and will design compelling tables making data comparison a powerful tool for the target audience.

Important statistical methods such as evaluation of outliers, analysis of variance, experimental design and estimation of uncertainty will be covered. The elements of effective standard operating procedures will also be explained.

Course Methodology

  • The material used in the training course will be based on exercises as well as regional and international case studies. Participants will frequently work in pairs as well as in larger teams.
  • Participants will have the opportunity to practice their new set of skills in technical report writing. They will be given the option to work on a report using data from their workplace or use model data supplied by the trainer.

  • Course Objectives:

    By the end of the course, participants will be able to:

    • Write effective technical reports and procedures that cater to the needs of their target audience
    • Present complex experimental data in a logical, clear and concise manner making optimal use of graphs, charts and tables
    • Build credibility by following the conventions of scientific writing to support explanations and arguments
    • Ensure technical documents achieve maximum impact by efficiently structuring the data and avoiding common written English mistakes
    • Analyze experimental data using the principles of statistical analysis

    Who Should Attend:

    Directors, VP’s, Administrative Staff, Managers and Supervisors in:

    • Research and Development Departments
    • Quality Assurance Departments
    • Quality Control Departments
    • Engineering Departments
    • Information Technology Departments
    • Documentation Departments
    • Manufacturing Departments
    • Operations Departments
    • Scientists and Technicians
    • Everyone supporting the R&D and operations activities by preparing technical documentation

    DAY 1 : (9 AM – 5 PM)

    Scientific Writing

    • Organization and structure of technical reports
    • Conventions and style in scientific writing
    • Correct use of English
      • Common mistakes
      • Verbs, nouns, prepositions and adjectives
      • Punctuation
    • Length and structure of sentences and paragraphs
    • Figures and tables
    • Citing scientific literature

    Statistical Methods

    • Distributions and types of data
    • Basic statistical techniques
    • Outliers
    • Analysis of variance
    • Experimental design
    • Estimates of measurement uncertainty
    • Rules governing the use of statistical techniques in pharmaceutical QC

    DAY 2 : (9 AM – 5 PM)

    Graphical Representation of Data

    • Options for presenting data in technical reports
    • Designing effective tables
    • Optimal types of graphs
      • Scatter graphs: linear and non-linear
      • Pie charts
      • Bar/column graphs
      • Radar plots
    • Use of error bars
    • Graphics tools in Microsoft Excel®

    Writing Effective Procedures

    • Definitions of a Standard Operating Procedure (SOP)
    • Best practice in SOP writing
    • The importance of brevity and clarity
    • Organization and structure of a SOP
    • Use of figures and diagrams
    • Point-of-use aids to compliance

    Dr. Mark Powell

    Mark Powell Scientific Limited


    Dr. Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team. He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements.

    He also provides training services, which are accredited by the UK’s vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.

    PRICING OPTIONS & REGISTRATION

    Seats are limited and based on first-come, first-serve

     

    The Orchid Hotel, Vile Parle

    70-C, Nehru Road, Near Mumbai Domestic Airport
    Mumbai, MH, India | December 6 – 7, 2018




    Call for Assistance: +91-80-4170-0521   Register Now