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.
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
- 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
- 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
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.
I get no greater satisfaction than guiding a client to resolving a problem, preventing others, while building a quality system to meet regulatory guidance and requirements. Long-term, mutually satisfactory relationships ensue. My experience as a successful QC director during a consent decree helps me understand FDA expectations and how to meet them. Communicating understanding of science, technology and useful statistics to operating personnel and management is a major objective of mine.
Expertise:
- Regulatory guidance / requirements, and science and technology for the management of pharmaceutical quality through Quality Systems, Metrics and Risk Management. Compliance Auditing; and FDA trained in the Quality System Inspection Technique (QSIT).
- Quality Systems with emphasis on laboratory and metrology operations, quality control / assurance, data integrity and management, CAPA, and validation / qualification / verification studies.
- Analytical method development and validation, conforming to CGMP & ICH guidance, based on Quality by Design and Design of Experiment principles and practices
- Conduct laboratory, manufacturing and stability investigations of OOS data / train personnel in how to conduct effective and compliant laboratory investigations
- Drug stability: operations, statistics, and expiration period setting
- Statistics and data analysis / Statistical Process Control / Six Sigma / Sampling Processes and Statistical Sampling Plans / Analytical Method and Manufacturing statistics and Process Capability assessment / FMEA & quantitative risk-based decision making for pharmaceutical operations / Equivalency demonstration / Validation statistics / Annual Product Review statistics
Extensive interaction with FDA at the District, Center, PQRI and AAPS committee activities; Member of ASTM E-11 and E-55 Quality Control and Statistics, and Pharmaceutical and Biopharmaceutical Manufacturing Technology committees, respectively - Excellent written and oral communications - Effective coach, mentor and trainer.
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