Introduction to CMC Statistics

Interactive Live Online Course. Limited Space Available, Register Early!

This one-day online course focuses on the application of statistics to common Chemistry, Manufacturing and Controls (CMC) issues in the pharmaceutical and biotechnology industries.  Emphasis will be on implementation and less on formulas and derivations, structured around CMC sections.

This live interactive course will covered:

• Quality Target Product Profile
  • Strength
    • Presentation of Data
    • Description of Data
    • Comparing Groups of Data
  • Stability
    • Assessment of Relationship
• Control of Drug Substance
  • Analytical Validation
    • Confidence Intervals
    • Tolerance Intervals
    • Equivalence Testing
  • In-process Testing
    • Control Charting
• Product Design
  • Process Robustness
    • Design of Experiments
  • Process Improvement
    • Sample Size

Spaces are limited, we will accept registration and reserve spaces in order as received.

To optimize your experience, we encourage participants to use their Video for interaction during this session.

Agenda

8:00 AM – 10:00 AM: Course Begin
10:00 AM – 10:15 AM: Mid-morning Break
10:15 AM – 12:00 PM: Course Continue
12:00 PM – 1:30 PM: Lunch Break
1:30 PM – 3:15 PM: Course continue
3:15 PM – 3:30 PM: Mid-afternoon Break
3:30 PM – 5:00 PM: Course continue
5:00 PM: Conclusion

Speaker:

Steven Walfish, President, Statistical Outsourcing Services

Mr. Walfish is Principal Science & Standards Liaison at United States Pharmacopeia (USP) responsible for the Statistics Expert Committee.  Prior to this role Mr. Walfish was Principal Statistician at Becton Dickinson in Franklin Lakes, NJ responsible for supporting continuous improvement efforts and process development for worldwide operations. Mr. Walfish has held roles at GE Healthcare, Human Genome Sciences and Chiron.  Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries.

Mr. Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues.   Steven has experience applying statistical methods to analytical method verification and validation and stability analysis.

Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

This training is designed for Managers, Supervisors and Scientists in the following areas:

• Manufacturing
• Quality Assurance
• Quality Control
• Stability
• Analytical Method Development

Registration Information:

1-DAY REGISTRATION:

$498 + HST CAD

Registration Closed

The registration fees are per person basis / per login.
Spaces are limited, we will accept registration and reserve spaces in order as received.

GROUP REGISTRATION DISCOUNT AVAILABLE:
Get additional discounts by participating in groups of three or more. SAVE MORE WITH GROUP REGISTRATION. Please contact us by email: enquiry@ipacanada.com or Call: 416-410-7402

Log in information will be provided 24-48 hours prior to the date of the course.
All participants will receive an e-Certificate of attendant 1 weeks after the course.