ComplianceOnline

You need not be a professional statistician to correctly utilize statistics for routine pharmaceutical and medical device problems and activities in management, quality, manufacturing, stability and technical support departments.

Science graduates with the aid of explanatory statistics and sampling software can design experiments and interpret data. They can perform their jobs more effectively and reliably with confidence. Explanatory statistics software reports the applicable assumptions for each test and whether the data satisfy the assumptions.

Explanatory statistics software is organized and utilized by what the operating objective or problem is, for example, compare two groups of data, describe numeric data, or determine the process capability. The burden of deciding what statistical test should be performed is vastly diminished. When the problem is chosen from the menus, the software selects and performs the right combination of appropriate tests and plots. It reports the results and conclusions in readily understandable language with presentation quality graphics that facilitate understanding. Calculations and plots are automatically performed. No need to struggle with statistical calculations and analysis any longer!

The test results and explanatory text plus graphics output support qualification and validation studies, problem solving, deviation and investigational studies, sampling, trending, SPC/SQC and many other statistics based problems.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completing this course participants should:

  • Understand the statistics methodologies associated with risk-based qualification of instruments and equipment, and validation of test methods and manufacturing processes.
  • Design studies and collect data in support of pharmaceutical laboratory and manufacturing operations.
  • Assess test methods, processes and materials for adequacy and conformance to requirements.
  • Establish acceptance criteria and sample sizes for validation and qualification studies.
  • Set raw material and finished product specifications.
  • Establish appropriate test method and manufacturing process characteristics.
  • Calculate, interpret and utilize confidence and tolerance intervals
  • Perform equality, equivalence, and inferiority and superiority studies.
  • Design sampling plans for experimental studies and incoming raw materials (acceptance sampling).
  • Design drug stability studies and establish drug expiration periods conforming to USP and FDA requirements.
  • Make valid comparisons and correct, risk based conformance decisions.
  • Assess linearity, accuracy, analytical and manufacturing process capability.
  • Prepare and interpret process behavior charts (SPC/SQC).
  • Identify controlled processes and predict future performance.
  • Identify normal and non-normal data – and work with each.
  • Communicate statistical analysis results, conclusions and claims.

Who will Benefit:

This course is designed for people responsible for developing, maintaining and/or improving analytical, quality and manufacturing operations at pharmaceutical and medical device companies. This includes individuals that have Quality Management Systems responsibilities for product and process development, test laboratories, and manufacturing. The following personnel will benefit from this course:

  • Senior quality managers
  • Quality, regulatory and compliance professionals
  • Manufacturing supervisors and scientists
  • Technical support department managers and scientists
  • Stability department managers and scientists
  • Calibration/metrology managers and scientists
  • Manufacturing process and test method developers
  • Quality control scientists
  • Qualification, validation and method/process transfer managers and scientists
  • Data reviewers
  • Anyone who collects, interprets and utilizes data
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • Session Start Time: 9:00 AM
  • Introduction and review of basic concepts in statistics and the use of explanatory software
    • Define variability-precision-variance-repeatability-standard deviation-relative standard deviation, alpha beta, type 1 and type 2 errors, statistical significance, mean, sample, random sample, population, uncertainty and intervals, confidence, accuracy, tolerance, process capability (Cpk/Ppk), power, outlier, homogeneity, acceptance sampling, AQL, LTPD, p-value, data types, descriptive statistics, margin of error, et al.
    • Introduce and demonstrate explanatory statistics software
    • Define and demonstrate the meaning and usefulness of the normal curve
  • Problem and solution: how to characterize and understand sample data. Is there an outlier in the sample?
  • Problem and solution: how to compare groups of data
  • Problem and solution: how to assess linearity for calibration
  • Problem and solution: how to simultaneously determine linearity and accuracy of a system
  • Problem and solution: how to determine sample size for studies
Day 02(8:30 AM - 4:30 PM)
  • Problem and solution: how to determine sampling plans for accepting raw materials from a stream of incoming lots.
  • Problem and solution: how to determine sample size for a sample taken from an isolated collection or population.
  • Problem and solution: how to set a drug expiration date by USP and FDA criteria
  • Problem and solution: Is the process in control? Predictable? Produce a homogeneous product stream?
    • Prepare SPC/Process Behavior Chart and interpret it
  • Problem and solution: Is this process/product capable of meeting its requirement?
  • Problem and solution: how to set a standard deviation target for a new method or process.
  • Problem and solution: how to set risk-based conformance decisions based on probable error. Does this product conform to its specification?
  • Problem and solution: how to set risk-based acceptance criteria based on probable error
  • Problem and solution: What is equivalence testing and when to use it? Demonstrate setting equivalence sample size and perform an equivalence test?
  • Demonstrate process simulation and its benefits
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Stanley Alekman

Stanley Alekman, Ph.D
Analytical Chemistry and Statistics Specialist

Employed as an independent pharmaceutical consultant for more than thirty-five generic and PhRMA pharmaceutical (API and drug products), biologics, excipients, contract and device manufacturers since 1998, including consent decree remediation programs.

A record of accomplishment and advancement in quality assurance and quality control, laboratory operations; regulatory compliance; research and development, and manufacturing management in the chemical and pharmaceutical industries as employee and consultant

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

Register Now

Online using Credit card

$1,299.00

Seminar One Registration

March 15-16, 2018, San Francisco, CA
(Registrations till February 2, 2018 - $1299)
(Registrations till March 7, 2018 - $1499)
(Registrations after March 7, 2018 - $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 with cookie; lunch, on both the 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 East 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.

Location:

San Francisco, CA
(Venue to be announced shortly)

March 15-16, 2018

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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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