ComplianceOnline

The quality and clarity of written technical documents is vital to the success of pharmaceutical companies. Such documents are used in regulatory submissions, to report the outcome of development work to clients, to record the results of investigations and to guide the direction of internal projects. In this course, participants will learn how to analyze and present technical data in a clear and concise manner. The use of visual tools such as graphs and flow charts will be covered, together with the design of effective tables. Statistical tools for data reduction and analysis will also be covered. The elements of effective standard operating procedures will also be explained. A large part of the course will be spent in a workshop setting, where attendees will produce technical content for comment and evaluation. The workshop can either be based on participants’ own data or model data provided by the trainer.

Attendees will be expected to bring a laptop computer. By the end of the course, attendees will be able to:

  • Understand the expectations of regulators when reviewing a NDA/BLA/MAA
  • Edit documents to remove superfluous words or phrases
  • Identify and correct ambiguous text
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar
  • 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
  • Follow the conventions of scientific writing to support explanations and arguments
  • Ensure technical documents achieve maximum impact by efficiently structuring the data and avoiding common mistakes in written English
  • Analyze experimental data using statistical principles

Learning Objectives:

  • Information required in regulatory submissions
  • eCTD format and style
  • The fundamentals of effective writing: accuracy, brevity and clarity
  • Common mistakes in written English
  • Effective use of figures and tables
  • Correct methods of citing literature sources in technical documents
  • Types of data distribution
  • Statistical treatment of experimental data
  • Design of Experiments (DoE)
  • Writing effective procedures

Who will Benefit:

  • Regulatory affairs professionals
  • Project managers
  • Technical staff with responsibility for report/procedure writing
  • Quality management
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08:30 AM – 08:59 AM – Registration Process, Meet & Greet
  • 9:00 AM -10:30 AM
    • Regulatory expectations
    • ICH, US FDA and EMA guidance on eCTD submissions
    • How much information to include
  • 10:30 AM -10:45 AM Break
  • 10:45 AM -12:00 Noon
    • Writing appropriately for the audience – who will read your report?
    • Organization and structure of technical reports
    • Use of templates
    • Conventions and style in scientific writing
    • Correct use of English
    • Length and structure of sentences
    • Citing scientific literature
    • Exercise: identifying and correcting poor writing
  • 12:00 Noon -1:00 PM Lunch
  • 1:00 PM -3:00 PM
    • Statistical methods
    • Types of data distribution
    • Basic statistical terms and techniques
    • Tests for normality
    • Outliers
    • Analysis of variance
    • Introduction to experimental design
    • Exercise: using appropriate statistical techniques
  • 3:00 PM - 3:15 PM Break
  • 3:15 PM - 4:30 PM
    • Graphical presentation of data
    • Options for presenting data in technical documents
    • Designing effective figures and tables
    • Use of error bars
    • Graphics tools in Microsoft Excel®
    • Exercise: selecting appropriate data presentation methods
Day 02(8:30 AM - 4:30 PM)
  • 08:30 AM – 08:59 AM – Registration Process, Meet & Greet
  • 9:00 AM -10:30 AM
    • Writing effective procedures
    • Differences in style between technical reports and procedures
    • SOP structure
    • Developing an effective procedure – risk-based approach
    • Use of diagrams and pictures
    • Procedure lifecycle management
    • Regulatory observations
    • Exercise: reviewing a SOP
  • 10:30 AM -10:45 AM Break
  • 10:45 AM -12:00 Noon
    • Workshop/group exercise: review of example reports – identifying good and bad practice
  • 12:00 Noon -1:00 PM Lunch
  • 1:00 PM -3:00 PM Report-writing workshop
  • 3:00 PM -3:15 PM Break
  • 3:15 PM -4:15 PM Report-writing workshop (continued)
  • 4:15 PM -4:30 PM Final questions, feedback and close
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Mark Powell

Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

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Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till April 15, 2020.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions for In-person Seminars:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
Offers:
  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Testimonials

    See What People Say About Us

    I knew some key points which can help to improve my report structure, overall lecturer has good skills in presenting information and knowledge on technical writing.

    Upstream Innovation Product Development Manager,

    Reckitt Benckiser

    Overall, the pace of the training is good. Trainer is responsive and knowledgeable. Online training can pose some difficulties at times too e.g. typing of the words might take some time.

    Technical Specialist,

    Reckitt Benckiser

    The training was useful and informative. There should be more examples specially on the statistics part.

    Packaging Innovation Associate,

    Reckitt Benckiser

    The presenter is very knowledgeable & the design of the presentations was most appropriate. It was a good training. Time slot selected was very good. Most of topics are crisp and to the point. Additional information can be added at booklet for each slide.

    Process Manager,

    Reckitt Benckiser

    Overall sessions were timing manageable and no technical issues during training. It would be better if participants could share their learning via workshop in every session to make more enthusiastic to everyone in the class.

    PD Manager,

    Reckitt Benckiser

    It would be enhance more focus on the training if the session is face to face.

    Senior Associate, R&D Operations,

    Reckitt Benckiser

    Training is so packed, and not time to digest the skills. It is great experience and the lecturer is very knowledgeable.

    Senior Process Engineer,

    Reckitt Benckiser

    The timing for the training is just nice, half a day for each session.

    Senior QC Chemist,

    Reckitt Benckiser

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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