Project management critical tasks within each project phase

Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military. 

It is not possible to present a complete treatment of project management in the span of 6-hours.  It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project.  Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.

We have distilled the key aspects of project management into three two-hour virtual seminar segments that will logically move participants from the beginning of the project management process to the end – from initiating the project to closing the project.

Project-Management

The seminar is designed to build a working understanding of the subject and for a quick start-up for those unanticipated project management assignments.

Who will be benefit by this:

  • Any member of a Cross Functional Project Team that has the Potential Opportunity to Lead that Project
  • Engineers
  • Marketing Associates
  • Product Managers
  • Program Managers
  • Contract Managers
  • Project Managers
  • Research & Development Associates, Managers, and Directors
  • Design Engineers
  • Manufacturing Managers

About the Inructor:

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

The FDA Drug Development Process

This webinar provides an overview of the FDA’s Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process – the GLP, GMP and GCP regulations.

This webinar is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on FDA requirements.

Why should you Attend:This webinar is a must for those who have to have an understanding of FDA’s Drug Development Process.

Areas Covered in the Session:

  • Overview of FDA’s Drug Development Process
  • Nonclinical studies required
  • Human clinical studies required
  • IND requirements
  • NDA requirements

Who Will Benefit:

  • Regulatory Affairs Personnel
  • Quality Personnel
  • Research Personnel
  • Clinical Personnel
  • Project Managers
  • Legal Personnel
  • Those personnel that require a general understanding of the FDA’s Drug Development Process
Speaker Profile

Albert A. Ghignone MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements. He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP). In addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical Research Group and the Naval Medical Research Group. He is a member of the Regulatory Affairs Professionals Society which elected him the 1984 Professional of the Year. He has served the society as Vice President, President and Chairman of the Board of Directors.

In recent years he has filed numerous FDA drug, biologic and medical device submissions for product approval. In addition he has been involved in two of the largest clinical trials conducted, the 8,000 patient clinical trial in Africa and the 16,000 patient clinical trial in Thailand.

Applied Statistics for FDA Process Validation

Course “Applied Statistics for FDA Process Validation” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, “”…the collection and evaluation of data, from the process design stage through commercial production..” 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.

Why you should attend:

The Food and Drug Administration (FDA) provided a guidance for industry in 2011 that has established a framework for process validation in the pharmaceutical industry. This guidance, titled “Process Validation: General Principles and Practices” consists of a three-stage process. The three stages are 1) Process Design, 2) Process Qualification, and 3) Continued Process Verification.

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance. This course teaches the application of statistics for setting specifications, assessing measurement systems (assays), using design of experiments (DOE), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although established for the pharmaceutical industry, it also provides a useful framework for other industries.

Analyses in this course use the point-and-click interface of JMP software by SAS.

Areas Covered in the Session

  • apply statistics to set specifications and validate measurement systems (assays)
  • develop appropriate sample plans based on confidence and power
  • implement suitable statistical methods into a process validation program for each of the three stages
  • Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
  • Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
  • Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

Who Will Benefit:

This seminar is designed for pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control.

  • Process Scientist/Engineer
  • Design Engineer
  • Product Development Engineer
  • Regulatory/Compliance Professional
  • Design Controls Engineer
  • Six Sigma Green Belt
  • Six Sigma Black Belt
  • Continuous Improvement Manager

Day 1 Schedule

Lecture 1: Introduction to Statistics for Process Validation

  • principles of process validation
  • stages of process validation

Primer on Statistical Analysis

  • basic statistics

Lecture 2: Primer on Statistical Analysis (cont.)

  • statistical intervals and hypothesis testing

Lecture 3: Primer on Statistical Analysis (cont.)

  • statistical intervals and hypothesis testing
  • ANOVA

Lecture 4: Primer on Statistical Analysis (cont.)

  • regression
  • run charts

Day 2 Schedule

Lecture 1: Foundational Requirements for Process Validation

  • setting specifications
  • analytical methodology

Stage 1 – Process Design

  • steps to DOE
  • screening designs

Lecture 2: Stage 1 – Process Design

  • response surface designs
  • establishing a strategy for process qualification

Lecture 3: Stage 2 – Process Qualification

  • introduction
  • incorporation of large-scale data
  • development of PPQ acceptance criteria
  • development of sampling plans

Lecture 4: Stage 3 – Continued Process Verification

  • statistical process control
  • process capability

Heath Rushing

Co-founder and Principal, Adsurgo

Heath Rushing is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. Previously, he was the JMP and Six Sigma training manager at SAS. He led a team of nine technical professionals designing and delivering applied statistics and quality continuing education courses. He created tailored courses, applications, and long-term training plans in quality and statistics across a variety of industries to include biotech, pharmaceutical, medical device, and chemical processing. Mr. Rushing has been an invited speaker on applicability of statistics for national and international conferences. As a Quality Engineer at Amgen, he championed statistical principles in every business unit. He designed and delivered a DOE course that immediately became the company standard required at multiple sites. Additionally, he developed and implemented numerous innovative statistical methods advancing corporate risk management, process capability, and validation acceptance criteria. He won the top teaching award out of 54 instructors in the Air Force Academy math department where he taught several semesters and sections of operations research and statistics. Additionally, he designs and delivers short courses in statistics, data mining, and simulation modeling for SAS.

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Cleaning Validations Using Extraction Techniques

Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process.

Why should you attend:Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient. Regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices. Therefore, cleanliness has become a hot topic in the medical device community. A thorough validation of the cleaning processes used to remove residual materials from newly manufactured medical devices is necessary to ensure patient safety.

Areas Covered in the Session:

  • Cleaning Validation Overview
  • Defining the Scope
  • Identifying the Contaminants
  • Choosing the Test Method
  • Choosing the Solvents
  • Setting Extraction Parameters
  • Validating the Extraction
  • Setting Limits

Who Will Benefit:

  • QA/QC Managers and Personnel
  • Validation Managers and Personnel

Speaker Profile

Kierstan Andrascik has worked in the medical device industry for more than 12 years. She founded QVET Consulting in 2009 to assist medical device manufacturers with their validation needs. She specializes in cleaning validations for both new and reprocessed medical devices and has established herself as one of the foremost experts in medical device cleanliness. She also provides guidance in many other areas including sterilization, biocompatibility, packaging, and materials characterization.

Previously, she worked at Nelson Laboratories in Salt Lake City, Utah where she served as study director covering a variety of testing including new device cleaning validations, materials characterization, and package testing. In 2002, she began developing a method to quantify residual manufacturing materials on medical devices. In 2005, ASTM published a similar method as F2459. Kierstan has been actively serving on the ASTM Device Cleanliness subcommittee since 2005. She received a Certificate of Achievement from ASTM in May 2007. In the June 2008 issue of Medical Design magazine, her article titled “How to tell if a device is really clean” was published. Then, in April 2011, her chapter “Cleaning Validations using Extraction Techniques” published in the 2nd edition of Handbook for Critical Cleaning. She has a BS in chemistry and mathematics, and an AS in Engineering from Shepherd University in Shepherdstown, West Virginia.

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Cleaning and Sanitation Training for Food Processors

We will cover several topics of value to food manufacturing sanitation team members. We will begin with a conceptual understanding of cleaning vs. sanitation.

We will then review proper cleaning techniques to ensure microbial and allergen residue removal. Attendees will learn about the chemicals used in industrial cleaning and sanitation and how to protect themselves against harmful exposure and accidents.

Residual Moisture Testing - Proven Techniques.jpg

Why should you attend: The industry has come a long way since the turn of the century, when the poor sanitation practices of many food manufacturing facilities was exposed. Recent events have highlighted the need for even better sanitation. The population has become decidedly more vulnerable and exposed to food borne illnesses linked to manufacturers.

The FDA cited Sunland Inc, the firm that manufactured various nut products recalled this year, for numerous sanitation violations. Failure to properly clean equipment and subsequent salmonella contamination of product resulted in a very poor outcome for this facility. Poor sanitation can also result in allergen cross contamination. Understanding where there are “dead ends” in product flow and difficult to clean areas is important for sanitation personnel to be aware of. What types of cleaning chemicals remove the various types of soils unique to each industry is also critical for an effective sanitation program. Very basic sanitation concepts and practices can make a big difference.

Course Modules & Content Details:

  • Cleaning and Sanitation practices specific to various areas of the manufacturing environment and the resultant risks
  • Types of soils and cleaning chemicals based on the properties of each
  • Results of exposure to hazardous chemicals, how to read labels and maintain chemical safety.

Areas Covered in the Session:

  • Scope of Cleaning and Sanitation
  • Sanitation Regulations and Best Practices
  • Cleaning
  • Chemical Safety
  • Review
  • Closing
  • Self Assessment

Who Will Benefit:

  • Food Manufacturing employees at all levels, especially sanitation and operations/production team members
  • Auditors who review facilities quality assurance programs
  • Customers who want to understand best practices that they should require of their suppliers will benefit
Speaker Profile
Melinda Allen is a Food Safety and Quality Consultant in the Food Industry. Melinda has had a long and dedicated career of Quality Assurance and Food Safety leadership with companies such as YUM Brands and Quiznos. Her consulting clients have included leaders in the field such as Burger King, Panda Express and Popeyes Louisiana Kitchen. She continues to work with many of these and additional clients. Melinda and her team of experienced professionals are available for Quality Assurance and Food Service auditing, Specification and Program Development and Training, Product Commercialization.

Medical Device Adverse Event Reporting Systems in EU, Canada and US

Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

This webinar will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner.

Why should you attend : Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.

To achieve compliance and to remain compliant with the adverse event reporting requirements, it is critical to accurately interpret and understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.

Areas Covered in the Session

  • Applicable and relevant regulations in EU, Canada and US
  • Definitions
  • Medical device adverse event reporting requirements in EU, Canada and US.
  • Medical device vigilance system during the post-production phase in EU.
  • Mandatory medical device problem reporting requirements in Canada.
  • Mandatory medical device reporting requirements in US.
  • Review of actual reporting forms in EU, Canada and US
  • Applicable and relevant guidance documents
  • Conclusion

Who Will Benefit:

  • Regulatory Affairs Managers, Directors and VPs
  • Clinical Affairs Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Compliance Managers and Directors
  • Sales and Marketing Managers, Directors, and VPs
  • Complaint Handling and Risk Management Managers and Directors
  • Site Managers, Directors, and Consultants
  • Senior and Executive Management
  • Compliance Officers and Legal Counsel
  • Business Development Managers, Directors, and VPs

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21 CFR PART 11: Complete Manual for Compliance Success

FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities.
21 CFR PART 11 Complete Manual for Compliance Success

The number of warning letters is increasing proportionally and we as quality and other professionals utilizing the technology and systems to support our businesses are not ready – we are not ready to prepare and host FDA inspections when Part 11 is in scope, we are unsure how to best use and implement Audit Trails and certainly we have challenges with internal and external auditing for Part 11 compliance. This webinar address all these topics and provides you with plenty HOW TO we as auditors and inspectors increase our comfort level with the regulation, with its elements and compliance and practically implement audit system and audit trails – especially since Audit Trails play major role in Part 11 compliance – they can be your best friends and/or worst enemies at the same time.

Areas Covered in the Seminar:

  • How to Prepare and Host FDA Inspections (will cover elements and details of preparation for the inspection as well as elements of the successful practices of hosting an FDA inspection when Part 11 is in scope or the scope of the inspection. We will also cover some commonly asked questions by the inspectors and benefits of being compliant)
  • Internal and External Auditing for Part 11 Compliance (this subtopic includes all aspects of auditing for Part 11 compliance- starting at the audit program level and then going down on how to prepare for an audit to how to successfully execute the audit and follow up on the completed audit. This subtopic also includes CAPA and responses for the audit findings related to Part 11 – what to expect and handle the difference between “regular” audits and Part 11 audits. We include some of the common audit findings and common pitfalls as well as tools for a successful planning and execution of the audit.)
  • Audit Trails (includes types of audit trails, strategies for implementing complaint audit trails, proms and cons of audit trails, how to use audit trails as an audit tool during the internal and external audit as well as during the FDA inspection visit, some examples of “should” and “shouldn’t” when it comes to the audit trails and commonly asked questions related to audit trails.)
  • Overview and Understanding of the Regulation (covers topics such as introduction and development of the regulation, what to expect in the future when it comes to the regulation, options for (non)compliance, “what ifs”, as well as most impactful sections and subsections of the regulations.)
  • How Part 11 Regulation Relates to Other Regulations (this subtopic compares the Part 11 regulation with other regulations focusing on commonalities so that you and your organization can see how easy/hard is to identify gaps as well as how harvest the low hanging fruits when striving to comply with Part 11 regulation. We cover comparison with 3-4 other regulations quoting the exact subsections of each.)
  • Sample Audit Questions (throughout the material, we ensure that we present you and prepare you to deal with some commonly asked audit and inspection questions. These questions are ready-made for you to use when you and your team are conducting internal and/or external audits, but they are also ready-made for you and your team to use as you prepare to/and host FDA inspection when Part 11 in scope of the inspection. We include some of the questions in the material presentation and in addition to that we provide you with additional 30+ commonly asked questions document which you can use for your references and training purposes.)
  • Trends; Warning Letter Examples; Advantages and Challenges of the Regulation (we conducted research to bring you and your team results of inspections and audits that have been conducted in past several years. We include trends and graphs showing how and where Part 11 regulations impacts you the most, but will also show examples of the warning letters that have been issued in last several years due to lack of compliance with the Part 11 regulation. Finally, we cover and include some examples of advantages and challenges you may be benefiting from or facing to address while striving to be Part 11 compliant.)
  • More (we talk about the importance and significance of the regulation regardless if it (currently) applies to you or not. We provide examples and HOW TO so that you and your team can get most out of the materials and presentation – and to be able to use it immediately after attending this training/webinar.)

Who Will Benefit:

  • Quality Managers
  • Quality Engineers
  • Manufacturing engineers
  • CAPA investigators
  • Inspectors
  • Six Sigma specialists
  • Consultants
Speaker Profile

Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation.