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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Register Now

Online using Credit card

$1,099.00

Seminar One Registration (USD)

March 30-31, 2020, Zurich, Switzerland
Registrations till December 10, 2019 - $1099
Registrations till January 1, 2020 - $1299
Registrations after January 1, 2020 - $1599




Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

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:
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.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location :

    Zurich, Switzerland
    (Venue to be announced shortly)

    March 30-31, 2020

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

    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

    Media Partner:

    Media Partner

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    Local Attractions of Zurich, Switzerland

    Kunsthaus Zurich

    Kunsthaus Zurich

    The Kunsthaus is Zurich's most important art museum and one of the most famous in Europe. Although the collection of the Kunsthaus Zürich ranges from Ancient times to the Victorian Era, the Swiss art museum is most noted for its modern and contemporary works from the 19th and 20th centuries. Top exhibits include the Giacometti wing and Rodin's Gate of Hell.

    Bahnhofstrasse

    Bahnhofstrasse

    Widely known as the principal boulevard in Zürich, the Bahnhofstrasse is Zurich's most famous shopping street. Lined with some of the city's most elegant boutiques and top department stores, the Bahnhofstrasse offers a delightful place for a day of shopping amongst some of the world's greatest luxury brands and jewelry stores.

    Zurich Zoo

    Zurich Zoo

    Elephants, rhinos, tigers, penguins and 20 species of monkeys are just some of the more than 360 animal species that can be admired at the Zurich Zoo. In the Masoala Rainforest Hall visitors can experience a piece of Madagascar first hand. A must-see for young and old.

    Limmat River

    Limmat River

    Switzerland's Limmat River is actually part of the Linth river, which continues from Lake Zurich. Zurich is the most famous city located along the Limmat Valley and the Limmat River provides a charming and beautiful waterway to explore the sights of Zurich by boat.

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    The Fraumünster Church overlooks one of Zurich's oldest squares and markets, the Münsterhof. Tracing its founding back to 853, when it was a Benedictine abbey, the church is home to five famous stained-glass windows by renowned artist Marc Chagall.

    Zurich Old Town

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    Zurich Old Town (Altstadt ) is a cultural, social and historical melting pot. The highest concentration of clubs in Switzerland, one of the most famous shopping miles, and a plethora of cultural offerings

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