Seminar on “Applied Statistics for FDA Process Validation” by GlobalCompliancePanel

The FDA in 2011 provided a guidance titled “Process Validation: General Principles and Practices” for Process Validation in the pharmaceutical industry, during which it established a framework for the same. This framework consists of a three-stage process:

1) Process Design

2) Process Qualification, and

3) Continued Process Verification.

So, what is Process Validation? It is described in Guidance for Industry Process Validation: General Principle and Practices as “…the collection and evaluation of data, from the process design stage through commercial production…” into which the three stages described above are delineated in this Guidance:

Stage 1: Process Design: This is the stage in which commercial manufacturing process is defined, based on knowledge gained through development and scale-up activities

Stage 2: Process Qualification: The stage in which the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

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

While this much is for theory, how do organizations understand the ways to implement these practically? These will be explained in detail at a two-day seminar that is being organized on November 5 and 6 by GlobalCompliancePanel, a leading provider of professional training for the areas of regulatory compliance.

Being organized in Philadelphia, PA, this in person, live seminar will feature the Co-founder and Principal, Adsurgo, Heath Rushing, as the Director. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Please register for this valuable learning session by visiting https://www.globalcompliancepanel.com/seminar/applied-statistics-for-FDA-process-validation-901969SEMINAR

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The aim of this course is to help its participants understand how to establish a systematic approach for implementing statistical methodologies into a Process Validation program that is consistent with the FDA guidance. The Director will begin with a primer on statistics, at which he will focus on the methods that will be applied in each remaining chapter.

He will then move on to giving an understanding of how to apply statistics for setting specifications and assessing measurement systems (assays), which are considered the two foundational requirements for Process Validation.

In the third and final step, the Director will show how to apply statistics through the three stages of process validation defined by requirements in the Process Validation regulatory guidance documents.

He will take up methods recommended by regulatory guidance documents through all these three stages and provide references to the specific citations in the guidance documents.

Heath will explain how to apply statistics for a range of functions. These include how to:

• Set specifications
• Assess measurement systems (assays)
• Use Design of Experiments (DOE)
• Develop a control plan as part of a risk management strategy
• Ensure process control/capability.

Although established for the pharmaceutical industry, it is a useful framework for other industries. Analyses in this course use the point-and-click interface of JMP software by SAS.

At this seminar, the Director will cover the following areas:

• 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.

Pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control, such as Process Scientist/Engineer, Design Engineer, Product Development Engineer, Regulatory/Compliance Professional, Design Controls Engineer, Six Sigma Green Belt, Six Sigma Black Belt, and Continuous Improvement Manager will benefit from this seminar.

Virtual Seminar on Upcoming Changes with HIPAA 2019

We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy.
The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do’s and don’ts with HIPAA – I want to add clarity for compliance officers.

It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Do you know all of the requirements of this enigmatic law? Are you abiding by them?

My goal is to make this extremely complex enigma known as “HIPAA” very easy to understand with a painless step by step approach to an otherwise harrowing task Times have changed and new laws are now in place concerning protected health information.

The best way to protect your practice or business and save yourself future headaches and possible litigation or Federal fines is to be proactive instead of reactive This once rarely enforced law has changed and you need to know what’s going on! Protect your practice or business!

These day’s trial attorney’s pose an even higher risk than the Federal government!

State laws are now in place increasing liability for patient remedies!

What factors might spurn a lawsuit or a HIPAA audit? are you doing these things?

We will be discussing 2019 changes taking place in Washington with the Health and Human Services regarding the enforcement of the HIPAA laws already on the books as well as some detailed discussions on the audit process and some current events regarding HIPAA cases (both in courtrooms and from live audits)

What are areas covered by the Instructor:

• Study all 18 Standards and 44 Implementation Specifications of the regulations
• Updates for 2019
• Requirements of Compliance Officers
• New definition of what constitutes protected health information
• Real life litigated cases
• BYOD
• Portable devices
• Business associates and the increased burden
• Emailing of PHI
• Texting of PHI
• Federal Audit Process
• HIPAA and suing – how this works
• Risk Assessment
• Best resources

Click to know more about this

The EU Clinical Trial Regulation – EU Filings & Registrations

The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. The webinar covers the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].

This course also covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

Attendees will leave the Course clearly understanding the requirements under the current Regulations. In addition, this Course has been updated to provide participants with competitive insight into:

• How the EU and individual countries within Europe interact
• Which registration procedure to use
• How regulations effect product development strategies
• Understanding the concerns/issues of European Regulatory Personnel
• How to negotiate with the regulators
• Information necessary for effective submissions
• Strategies for streamlining the registration application process for faster approval
• The advantages and disadvantages of various registration procedures
• How to efficiently initiate trials first patient, first visit
• How to link the strategy of Country Selection to an ultimate EU registration pathway
• How to stay compliant What can make the difference in your data passing Regulatory scrutiny
• Related area-GCP and PV-reporting updates
• Impending Changes of the EU Clinical Trial Regulation and timing for Implementation

Who will get the benefit:

• Business Management
• Project Team Members
• Legal Team Members
• Clinical Operations Staff
• Quality Assurance, Monitors, CRAs
• Regulatory Affairs
• Investigators & Site Study Staff
• CROs, Consultants, Insurers

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eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD – Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.  Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.

Those who are benefited by this

• Regulatory Affairs
• Quality Assurance
• Pharmacovigilance
• Project Management
• Regulatory Operations
• Anyone responsible for providing content for the CTD

Instructor:

Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).

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.

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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.

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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 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.

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.

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What are the FDA’s Process Validation requirements?

Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the capability of delivering quality products consistently.

The FDA’s process validation requirements are set out in its general principles of Process Validation. Starting from 1987, the FDA has been issuing guidelines at intervals to state, improve and strengthen the general principles of Process Validation. In almost a quarter century of the first guideline, the revision of January 2011 came into being. This guideline is considered a landmark and a guide for PV professionals since it reworked extensively and expanded the general principles on process validation. It is the current guideline from the FDA on Process Validation requirements.

These are what the FDA’s 2011 guideline on general principles on Process Validation propagate:

• Incorporation of the principles of sound science
• Taking steps to assess and mitigate risk
• Bringing about improvements in every stage of the process
• Adapting the science-based principles of contemporary manufacturing
• Fostering and encouraging innovation

The centrality of control to process validation

Process validation is tied to the product lifecycle approach by the FDA general principles on process validation of 2011. The central purpose of process validation is to ensure that the process is in a state of control at all stages of production.

The following points illustrate the reason for which the FDA expects its PV requirements to be met:

• Being a process that is ongoing and continuous, PV begins at the earliest stages of production and goes on till the product’s lifecycle is completed
• Those in charge of commercial production should have deep and intimate knowledge of the workings of PV principles
• Only this knowledge helps PV professional locate the sources of variability and address them
• Only PV into which risk management is built frees errors from the product

The three stages of PV

The FDA stipulates three layers or stages on which its general principles of Process Validation are built:

• Process design: The stage in which the knowledge gained helps the commercial process define the process development activities
• Process qualification: The stage where PV guarantees that the process design has the capability for being reproduced at industrial level
• Continued Process Validation: The most important stage PV in that this is where the element of control into the routine production process is introduced and built; Continued Process Validation takes under its ambit all activities such as continuous verification, maintenance, and process improvement. Information is collected and monitored during commercialization to assess the Continued Process Validation stage.

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Seminar

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.

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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

Click Here to Continue Learning

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.

Background:

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.

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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.

When products are refused, you have different options. Some options may cost more than others. For example, your product can be seized and destroyed by the government. You may be fined if you do not act in a timely manner. These are common problems that become prohibitively expensive. You should know how to avoid common problems or at least how to mitigate the cost by using established and effective business planning.

Learn how to deal with common problems, such as returns for repair, importing QC samples, and investigational products

On a positive note, the FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. One other perk is that FDA offers export certificates, for a modest fee, which may give you a competitive advantage in foreign markets. In some cases, a FDA export certificate is required by foreign governments. Finally, the new EU Medical Device Regulation will change how FDA manages foreign inspections and in your favor.

Who Will Benefit:

• Domestic importers
• Foreign exporter
• Initial importers
• International trade executives
• Venture Capitalists
• Marine insurance underwriters
• Import Brokers
• Regulatory affairs managers
• Import / Export consultants
• In-house counsel
• Contract specialists
• Logistics managers
• Third party establishment inspection entities
• Sales managers
• Investors

Day 1 Schedule

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Lecture 1:

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

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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”

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Lecture 3:

Import Delays Import Alerts Detention Refusals

Day 2 Schedule

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Lecture 1:

Foreign Inspections FDA 483 – Inspectional Observations

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Lecture 2:

FDA Warning Letters and Automatic detention

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Lecture 3:

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

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Lecture 4:

FDA Export Program Special Import Issues

• Trade Shows
• Personal Use
• Compassionate Use

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.

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