Seminar on Validation and Troubleshooting of Pharmaceutical Water Systems

 Description:

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don’t work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn’t recur.

Why you Should attend:

Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.

Who Will Benefit:

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the “true” whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

  • Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
  • Quality Assurance personnel responsible for water system deviation management and change control
  • Regulatory and Compliance professionals responsible for FDA interactions
  • Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
  • Facility Engineers responsible for water system design or renovation

Agenda:

Day 1 Schedule

Lecture 1:

What Makes Water Systems Have Microbial Quality Problems

  • Understand biofilm basics and how it develops
  • Understand the impact of biofilm on the commonly used purification unit operations
  • Understand how various commonly used microbial control strategies work (or don’t work) to control biofilm development
  • Understand the how, where, and why of microbial monitoring, action levels, etc.
  • Debunk a few water system myths
  • Get answers to your own water system questions

Lecture 2:

Successful Sanitization Approaches for Trouble-Free Water Quality

  • Material and construction limitations
  • Continuous vs intermittent sanitization
  • The importance of biofilm removal
  • How sanitants work (or don’t work)
  • When to sanitize
  • Troubleshooting sanitization problems

Lecture 3:

Water System Validation by Logic Instead of Tradition

  • Why validate a water system?
  • Basic ground rules for water systems before you validate them
  • Micro Test Method “validation”
  • Minimum validation expectations
  • How to figure out what you should validate
  • What happens after the honeymoon is over
  • Is validation ever really over?
  • Special considerations for lab water systems
  • Are packaged waters a viable option?

Lecture 4:

Implementing Changes to a Validated System

  • Purpose of a Change Control program – a help, not a hindrance
  • When is a change major vs minor, requiring full vs limited re-qualification?
  • What about water use during re-qualifications?
  • FDA validation expectations
  • Reliance on logic and common sense and the disservice of precedent and paradigms
  • Additional useful tips

Lecture 5:

Reducing Water Microbial Excursions & Improving Investigations

  • What are excursions?
  • Water system dilemma: process control or quality control (utility or raw material), or both
  • Intended roles of Alert/Action Levels and Specifications
  • Investigation, necessary and often fruitless
  • Excursion responses and impact
  • Criticality of valves, hoses, & outlet flushing
  • Diagnosing the source of the problem
  • Minimizing unnecessary excursion responses through best practices

Day 2 Schedule

Lecture 6:

Understanding and Controlling Endotoxin

  • Where does endotoxin come from?
  • What are the properties of endotoxin?
  • How do you get rid of it?
  • How do you detect it?
  • What assay controls are used?
  • What are the endotoxin specs for water?
  • How do you control it?

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

  • Water harmonization that has occurred
  • Water Micro TM “Dis-Harmonization”
  • A little about Biofilm
  • Biofilm diversity in water systems
  • Micro TM options and evaluation protocol
  • The good and bad of Micro harmonization
  • Where RMMs can fit in
  • Parting wisdom

Lecture 8:

Microbial Enumeration Issues with High Purity Water Systems

  • Microbial Enumeration Issues with High Purity Water Systems
  • Biofilm enumeration issues (planktonic vs surface)
  • Traditional cultivative approach issues
  • Validation of your test method
  • Alternative TM choices (advantages/disadvantages)
  • Significance of water isolates
  • Sampling issues
  • Establishing Alert/Action Levels and Water Specs and defending them to FDA

Lecture 9:

Water System Investigation “How-To’s” and Example Case Studies

  • Gathering and assessing existing data and symptoms
  • Considering user opinions
  • Investigation approach elements
  • Recognizing red herrings/false positives
  • Recognizing possible root causes
  • Water system contamination case studies
  • Parting kernels of water system wisdom

Lecture 10:

What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues

  • PW, WFI, Pure Steam micro specifications?
  • <1231> Starting water issues
  • <1231> Misunderstood issues clarified
  • <1231> Microbiological test issues clarified
  • <1231> Suggested micro test method
  • <1231> Micro Specifications
  • <1231> Alert and Action Levels and max’s
  • Recent/Upcoming USP water changes
  • Discrepancies between pharmacopeia’s

 

Speaker:

Dr Teri C. Soli

Principal Consultant, Soli Pharma Solutions

T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering troubleshooting and training expertise covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control. He has 38 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.

His career-long water systems and contamination troubleshooting experience, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.

Location:  Philadelphia, PA Date: April 23rd & 24th, 2019 and Time: 9:00 AM to 6:00 PM

Venue:  DoubleTree by Hilton Philadelphia Airport, 4509 Island Avenue, Philadelphia, PA 19153

 

 

Price:

1 ATTENDEE $2,000, Register for 1 attendee

5 ATTENDEES $10,000, Register for 5 attendees

10 ATTENDEES $20,000, Register for 10 attendees

Until March 20, Early Bird Price: $2,000.00, From March 21 to April 21, Regular Price: $2,200.00

 

Sponsorship Program benefits for seminar

For More Information– 

 

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

globalcompliancepanel@gmail.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: 

 

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Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).

A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability. These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets their responsibility for meeting it. As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt.

New technologies will continue to emerge that will change the way companies do business. While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

Why you should attend

FDA requires that all computer systems that handle data regulated by the Agency be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.

The guidance was revisited for its application to the medical device industry in the 1990s, as the first issuance addressed pharmaceuticals only. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many FDA-regulated organizations began seeking ways to move into a paperless environment.

This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures, but still remains somewhat confusing. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Who Will Benefit

  • Information Technology Analysts
  • Information Technology Managers
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors Engaged in Internal Inspection

Session 1 (90 Mins):

  • FDA Regulatory Oversight
  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • GAMP 5 Software Categorization
  • System Risk Assessment

Session 2 (90 Mins):

  • 21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)
  • Security, Access, Change Control and Audit Trail
  • Validation Documentation

Session 3 (90 Mins):

  • 7 Most Common Problems with Validation
  • FDA Audit Preparation

Session 4 (90 Mins):

  • Policies and Procedures
  • Training and Organizational Change Management
  • Industry Best Practices and Common Pitfalls
  • Q&A

Speaker Profile

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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Tougher Import Rules for FDA Imports in 2019

 

Course “Tougher Import Rules for FDA Imports in 2019” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Description:

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA’s thinking, negotiate with the FDA and offer anecdotal examples of FDA’s import program curiosities.

Why you should attend:

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new “Automated Commercial Environment” computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port.

Who Will Benefit:

  • Domestic importers
  • Foreign exporter
  • Initial importers
  • International trade executives
  • Venture Capitalists
  • Marine insurance underwriters

Agenda:

Day 1 Schedule

Lecture 1:

FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation

Lecture 2:

FDA Import Process (continued)

  • Import Brokers
  • Prior Notice Information
  • CBP and FDA computer programs
  • Import Codes
  • Bonds and Bonded Warehouses
  • FDA “Notice of Action”

Lecture 3:

Import Delays Import Alerts Detention Refusals

Day 2 Schedule

Lecture 1:

Foreign Inspections FDA 483 – Inspectional Observations

Lecture 2:

FDA Warning Letters and Automatic detention

Lecture 3:

Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical

Lecture 4:

FDA Export Program Special Import Issues

  • Trade Shows
  • Personal Use
  • Compassionate Use

 

Speaker:

Casper Uldriks

ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed.

Location:  Washington, DC Date: April 4th & 5th, 2019 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON

 

Price:

1 ATTENDEE $2,000, Register for 1 attendee

5 ATTENDEES $10,000, Register for 5 attendees

10 ATTENDEES $20,000, Register for 10 attendees

Until March 10, Early Bird Price: $2,000.00
From March 11 to April 02, Regular Price: $2,200.00

 

Sponsorship Program benefits for seminar

For More Information– 

 

 

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: 

 

Registration Link 

Follow us on LinkedIn: 

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Seminar on Biostatistics for the Non-Statistician

Why should you attend:

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.


Who will benefit:

  • Physicians
  • Clinical Research Associates
  • Clinical Project Managers/Leaders
  • Sponsors
  • Regulatory Professionals who use statistical concepts/terminology in reporting
  • Medical Writers who need to interpret statistical reports

Day 1 Schedule


Lecture 1 (90 Mins):

Why Statistics?

  • Do we really need statistical tests?
  • Sample vs. Population
  • Statistician ≠ Magician. What statistics can and can’t do.
  • Descriptive statistics & measures of variability.

Lecture 2 (90 Mins):

The many ways of interpretation

  • P-values
  • Effect sizes
  • Confidence intervals
  • Statistical vs. Meaningful significance

Lecture 3 (90 Mins):

Common Statistical Tests

  • Why Test? Null Hypothesis Significance Testing (NHST)
  • Comparative tests
  • Correlation
  • Multiple Regression analysis
  • Non-parametric techniques

Lecture 4 (90 Mins):

Bayesian Logic

  • A different way of thinking
  • Bayesian methods and statistical significance
  • Bayesian applications to diagnostics testing
  • Bayesian applications to genetics

Day 2 Schedule


Lecture 1 (90 Mins):

Interpreting Statistics – Team Exercise

  • Team Exercise: Review a scientific paper and learn how to
  • Interpret statistical jargon
  • Look for reproducibility, transparency, bias, and limitations
  • Convey information coherently to non-statisticians

Lecture 2 (90 Mins):

Study power and sample size

  • Review of p-value, significance level, effect size and how they are use in sample size calculations
  • Formulas, software, and other resources for computing a sample size.

Lecture 3 (90 Mins):

Developing a Statistical Analysis Plan

  • Using FDA guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP).
  • An SAP template will be given to all attendees.

Lecture 4 (90 Mins):

Specialized topics/Closing Comments/Q&A

  • Logistic Regression.
  • Comparing survival curves
  • Cox Regression
  • Question and answer session.

Speaker

Elaine Eisenbeisz

Owner and Principal Statistician, Omega Statistics

Elaine Eisenbeisz, is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.

In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.

Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine received her Master’s Certification in Applied Statistcs from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.

Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutriceutical and fitness studies with QPS, a CRO based in Delaware. Elaine has also worked as a contract statistician with numerous private researchers and biotech start-ups as well as with larger companies such as Allergan and Rio Tinto Minerals. Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at http://www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.

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How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud

Course “How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
  • Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
  • The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
  • Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
  • This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions.
  • Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated.
  • Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
  • Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
  • This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Course Objectives:

  • Understand what is expected in 21 CFR Part 11 and Annex 11 inspections
  • Avoid 483 and Warning Letters
  • Learn how to buy COTS software and qualify vendors.
  • Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
  • Requirements for local, SaaS, and cloud hosting
  • How to select resources and manage validation projects
  • “Right size” change control methods that allows quick and safe system evolution
  • Minimize the validation documentation to reduce costs without increasing regulatory or business risk
  • Write test cases that trace to elements of risk management
  • Protect intellectual property and keep electronic records safe

    Day 1 Schedule


    Day 1 (8am to 5pm; 0.5 registration, 1.0 lunch, 0.5 (2-15min) breaks, 7.0 class = 9.0)
    8:00am to 8:30am registration
    8:30am class starts


    Lecture 1:
    Introduction to the FDA (1:30) {1:30}

    • How the regulations help your company to be successful
    • Which data and systems are subject to Part 11

    Lecture 2:
    21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures (4:00) {5:30}

    • What Part 11 means to you, not just what it says in the regulations
    • Avoid 483 and Warning Letters
    • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
    • How SaaS/cloud computing changes qualification and validation
    • Ensure data integrity, security, and protect intellectual property
    • Understand the current computer system industry standards for security, data transfer, and audit trails
    • Electronic signatures, digital pens, and biometric signatures
    • SOPs required for the IT infrastructure
    • Product features to look for when purchasing COTS software
    • Reduce validation resources by using easy to understand fill-in-the-blank validation documents

    Lecture 3:
    The Five Keys to COTS Computer System Validation (0:30) {6:30}

    • The Who, What, Where, When, and Why of CSV

    Lecture 4:
    The Validation Team (0:30) {7:00}

    • How to select team members
    • How to facilitate a validation project

    Day 2 Schedule


    Day 2 (9am to 3:30pm; 1.0 lunch, 0.5 (2-15min) breaks, 5.00 class = 6.5)


    Lecture 5:
    Ten-Step Process for COTS Risk-Based Computer System Validation (1:00) {1:00}

    • Learn which documents the FDA expects to audit.
    • How to use the risk-based validation approach to lower costs.
    • How to link requirements, specifications, risk management, and testing.
    • Document a computer system validation project using easy to understand fill-in-the-blank templates.
    • Based on: “Risk-Based Software Validation – Ten Easy Steps” (Davis Horwood International and PDA – http://www.pda.org, 2006).

    Lecture 6:
    How to Write Requirements and Specifications (0:30) {1:30}

    • Workshop for writing requirements and then expanding them for specifications

    Lecture 7:
    How to Conduct a Hazard Analysis/Risk Assessment-Exercise (0:30) {2:00}

    • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

    Lecture 8:
    Software Testing (1:00) {3:00}

    • Reduce testing by writing test cases that trace to elements of risk management.
    • How to write efficient test cases

    Lecture 9:
    System Change Control (0:30) {3:30}

    • How to manage a validated system with minimal documentation

    Lecture 10:
    Purchasing COTS Software (0:30) {4:00}

    • How to purchase COTS software and evaluate software vendors.

    Lecture 11:
    Cost Reduction Without Increasing Regulatory or Business Risk (1:00) {5:00}

    • How to save money
    • How to increase quality
    • How to increase compliance with less documentation

      Carolyn Troiano

      Consultant, BrainStorm Central Consulting

      Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

      During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

     

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A to Z’s of HIPAA Privacy, Security, and Breach Notification Rules

Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them.

It is designed to provide intensive, two-day training in HIPAA compliance, including what’s new in the regulations, what’s changed recently, and what needs to be addressed for compliance by covered entities and business associates.

It provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.

Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.

Benefits from this Rules:

  • Information Security Officers
  • Risk Managers
  • Compliance Officers
  • Privacy Officers
  • Health Information Managers
  • Information Technology Managers
  • Medical Office Managers
  • Chief Financial Officers
  • Systems Managers
  • Legal Counsel
  • Operations Directors

HIPAA Privacy Rule Principles, Policies and Procedures

  • Patient Rights under HIPAA
  • Limitations on Uses and Disclosures
  • Required Policies and Procedures
  • Training and Documentation Requirements

Recent and Proposed Changes to the HIPAA Rules

  • New Penalty Structure
  • New HIPAA Audit Program
  • New Patient Rights
  • New Obligations for Business Associates

Go through here for detailed rules

High degree of Assurance in its Manufacturing Process to Justify Commercial Distribution of the Product

Focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance.

The guidance further delineates the ‘process design stage through commercial production’ into three distinct stages of the product lifecycle:

Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

The first stage of process validation is process design. The Process Validation guidance document states, “A successful validation program depends on information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes:

Manufactures should:

  • Understand the sources of variation
  • Detect the presence and degree of variation
  • Understand the impact of variation on the process and ultimately on product attributes
  • Control the variation in a manner commensurate with the risk it represents to the process and product.”

The second stage of process validation is process qualification. Although stage 2 has two elements, this course will focus on recommendations for the second element, PPQ. PPQ “combines the actual facility, utilities, equipment (each now qualified), and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches.” Additionally, the process validation guidance document that “Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its manufacturing process to justify commercial distribution of the product. Focusing exclusively on qualification efforts without understanding the manufacturing process and associated variations may not lead to adequate assurance of quality.”

The third stage of process validation is continued process verification. The process validation guidance document defines the need for this stage: “After establishing and confirming the process, manufacturers must maintain the process in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change.” Manufacturers should use ongoing programs to collect and analyze product and process data to evaluate the state of control of the process. These programs may identify process or product problems or opportunities for process improvements that can be evaluated and implemented through some of the activities described in Stages 1 and 2.”

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance. It begins with a primer on statistics, focusing on methods that will be applied in each remaining chapter. Next, it teaches the application of statistics for setting specifications and assessing measurement systems (assays), two foundational requirements for process validation. Lastly, the course applies statistic through the three stages of process validation defined by requirements in the process validation regulatory guidance documents. Methods taught through all three stages are recommended by regulatory guidance documents; references to the specific citations in the guidance documents are provided.

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