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

The stage in which the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

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.

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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.

A Systematic Approach to Implementing Statistical Methodologies

Focusing exclusively on qualification efforts without understanding the manufacturing process and associated variations may not lead to adequate assurance of quality.

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.

Areas covered by the Instructor:

  • 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 by this:

  • 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 and register for 2 day seminar

Virtual Seminar on Upcoming Changes with HIPAA 2019

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

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.

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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

Want An Easy Fix For Your Good Laboratory Practices? Read This!

This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

GLPs are enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

What are the Learning Objectives:

  • What are Good Laboratory Practices
  • Why were they created
  • What is the objective of GLPs and how are they associated with GMPs and SOPs
  • Statistical procedures for data evaluation
  • Instrumentation validation
  • Analytical and laboratory certification
  • Documentation and maintenance of records
  • Consequences of noncompliance
  • Disqualification and reinstatement

Who will Benefit:

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Research and Development Personnel
  • Regulatory Affairs Personnel
  • Project Managers
  • Manufacturing Managers
  • Validation Engineers
  • Internal Auditing Personnel
  • Microbiology Personnel
  • Auditors

Please Continue for Complete Details

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.

How the Things Will Change The Way You Approach [Phase I Gmps]

Including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

manufacturing

So, that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.

  • Directors
  • Managers
  • Supervisors in Regulatory Affairs
  • Manufacturing
  • Quality Assurance, and Clinical Operations

200+ followers. WOWWWWWW…

followed- 200

Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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