QbD Development Process Evaluating Critical Steps

The selection of robust process parameters for Quality designs, and how to establish criteria to measure and discernable observances.

  • How to Build quality, safety, and efficacy into the manufacture of drug product
  • The ICH guidelines for pharmaceutical manufacturing
  • Risk-based, modern pharmaceutical manufacturing
  • Understanding Target Quality Profile, Critical Quality Attributes
  • Process parameters and design experiments
  • Regulatory concerns FDA and EMA on QbD

To establish a procedure for the proper assessment of product and process design, Also, to align evaluation of product quality standards for chemistry manufacturing and controls (CMC) review and to maintain quality standards per Office of Pharmaceutical Science (OPS)

It should be noted that OPS is responsible for assuring that the quality of drug products for the entire pharmaceutical industry follow uniform policy and review processes during drug product development (the manufacture and formulation).

Therefore, it is incumbent on all personnel involved with the preparation of documentation for subsequent submission to the regulatory authority recognize the importance of creating and maintaining a clear scientific and sound approach for all products.

  • Quality target product profile (QTPP) forms the basis for design and the development of the product. Considerations for the Quality Target Product Profile (ICH guideline Q8 R2)
  • Critical quality attributes (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality
  • Process Analytical Technology (PAT) which is a Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
  • Risk Assessment (RA)one can recognizing critical attributes that are going to affect final quality of product

Process Evaluating Critical Steps

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Best Ways and Ideas for General Data Protection Regulation(GDPR)

The core part of which is the standardization and unification of data protection regulations across all the countries of the EU.

Fremont, CA: A 90-minute webinar is being organized by Compliance4All, a leading provider of professional training for the areas of regulatory compliance, on January 24. The learning gained at this webinar will be on the best ways and ideas for General Data Protection Regulation (GDPR). The speaker at this webinar is Derk Yntema, who is a highly experienced ICT, security management and Regulatory Affairs professional.

Please visit https://www.compliance4all.com/control/w_product/~product_id=502310LIVE to enroll for this webinar.

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The General Data Protection Regulation (GDPR) is a quintessential regulatory law regarding the protection of data of people in the European Union (EU). Formally coded as Regulation (EU) 2016/679, the GDPR has two primary purposes:

  • Empowering citizens and residents of the EU by placing the control of personal data in their own hands
  • Enhancing the ease of doing global business within the EU by greasing the regulatory process and environment, the core part of which is the standardization and unification of data protection regulations across all the countries of the EU.

gdpr

The Council of the European Union and the European Commission, institutions of the European Parliament, have created the GDPR regulation to unite and strengthen all areas of data protection for all individuals within the European Union (EU). These bodies also have the export of personal data to regions outside the EU within their purview.

One of the core parts of the GDPR is its requirement, from companies that process Personally Identifiable Information (PII) of European citizens, to have complete knowledge of all PII processing going on in their business. Companies should implement appropriate organizational and technical controls after a Data Protection Officer (DPO) assesses them.

It goes without saying that compliance with the GDPR is a prerequisite for companies that want to do business in the EU. This can come about only when they have a total and clear understanding of the law. In imparting this learning, this webinar will offer the best ways and ideas for General Data Protection Regulation (GDPR).

Benefits of compliance

The benefits that companies gain by implementing the GDPR are multifold:

  • They get a thorough understanding of how to process Personally Identifiable Information (PII)
  • The GDPR enhances and harmonizes security controls across the 27 EU members
  • As a result, customer confidence soars, as customers are confident that the tougher rules protect and safeguard their data
  • Implementing GDPR makes doing business in the EU much less complicated.

Inestimable costs of non-implementation

When companies fail to implement the relevant provisions of the GDPR properly, they face a slew of complications. The EU fixes exorbitant costs on companies that fail to implement the requirements:

  • Companies that violate the provisions of the GDPR may have to cough up close to two percent of the total worldwide revenues
  • They could end up having to pay fines that could go up to € 20 million
  • They could face cumbersome and time-consuming legal action
  • Companies that violate the provisions of the GDPR earn a very bad reputation in the market.

The aim of this webinar is to help participating companies understand the letter and spirit of these laws so that they stay compliant and do not land on the wrong side of the law. The expert will show the best ways and ideas for General Data Protection Regulation (GDPR) in the prescribed manner so that the participating organizations derive the many benefits of this law and avoid the negatives of non-implementation.

During this 90-minute session, Yntema will cover the following areas:

  • What is Privacy?
  • How to Protect Privacy
  • What is PII
  • What is in the GDPR (General Data Protection Regulation)
  • How to Comply.

This session will be of extremely high value to core personnel involved in the implementation of this legislation, such as Board of Directors, Supervisory Board, CxO’s, and Compliance Managers/Officers.

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About the speaker:

With more than 15 years of experience in ICT- and security-management, Derk Yntema brings demonstrated capacity to implement innovative security programs that drive awareness towards information security and strengthen organizations. He has proven knowledge of privacy legislation and in helping companies implement privacy compliance requirements.

http://www.eugdpr.org/

http://data.consilium.europa.eu/doc/document/ST-9565-2015-INIT/en/pdf

http://mlawgroup.de/news/publications/detail.php?we_objectID=227

6 Enticing Ways to Improve Your Software Verification Skills

Software verification and validation failure is the third most often cited violation for medical devices by the FDA.

Fremont, CA: Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a webinar on January 22 on the topic of Software Verification & Validation. This 90-minute session is aimed at imparting six enticing ways to improve your software verification skills.

The speaker, Lena Cordie, who brings over 20 years of quality and project management experience, will show how organizations can vet their software verification skills to ensure that they meet the set regulatory standards, which is a prerequisite for gaining approval for their products and to also gain consumer confidence.

Please visit https://www.compliance4all.com/control/w_product/~product_id=502319LIVE to enroll for this session.

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The primacy of software verification and validation in a medical device can never be understated. Software verification and validation is that crucial seal on the medical device that assures that the product performs its set functions satisfactorily while meeting the specifications set out for it.

The importance of having the software verified and validated can be understood from the fact that this is the essential requirement that certifies that the product performs satisfactorily. Failure to meet verification and validation standards results in a substandard product, the surest recipe for disaster which could be of any magnitude. Software verification and validation failure is the third most often cited violation for medical devices by the FDA.

But software in medical devices being of a complex nature, the result of a complex interplay of not only elements within the device, but also many connecting devices and the users. This being its nature, it has to be designed in such a fashion that all these are in perfect sync with each other. While this is the primary challenge of developing software for medical devices; ensuring that the product also simultaneously meets regulatory requirements, set out in Part 11, which are not lax by any stretch of imagination, is another.

The goal of this extremely valuable session is to help participants overcome the fears and anxieties concerning software verification and validation. The speaker, Lena Cordie, will help participants ease the pain of meeting regulatory standards for software verification and validation.

She will get down to explaining the FDA 11-element documentation model that is most preferred in various applications by the FDA. She will include ERP, in-device, as-device, process/equipment control and cGMP data/Part 11 applications in this discussion. Other areas into which she will delve include the use of FDA guidance’s, GAMP 4/5, 21 CFR 11, and other applicable industry software validation models, all of which are complemented with a learning of the ISO 14971/ICH Q9 Risk Management models and their real-world implementation.

The core of her teaching at this crucial webinar will be on offering understanding of six enticing ways to improve your software verification skills. These are:

  • Developing and creating buy-in for a project validation plan
  • Understanding what the FDA accepts as an appropriate documentation model
  • Beyond just in-product software V&V – understanding FDA’s expectation for your testing software, ERP software and more
  • When and how to use DQ, IQ, OQ, PQ or their equivalents
  • How GAMP 4/5 requirements fit into your V&V planning and execution
  • Detailing the FDA’s 11 key V&V documentation elements.

This webinar is of invaluable benefit to professionals in medical device industries who have to deal with some or another aspect of software verification and validation. These include Software Developers and Managers, Internal Auditors, Quality Assurance and Management Personnel, Software Quality Personnel, Software Test Personnel, Regulatory Affairs Management Personnel, IT Managers and System Administrators, and Software Validation Engineers.

Lena will cover the following areas at this webinar:

  • FDA Quality System Requirements for software
  • FDA guidelines on software verification and validation
  • Smart software verification methods
  • How to design smart validation tests
  • How to conduct black box testing and white box testing to perform thorough validation.

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About the speaker:

Lena Cordie, who works as a consultant at Qualitas Professional Services, LLC, is a senior quality and project management specialist who has more than two decades in the medical device industry. During these years, she has gained expertise of overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.

She has been helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.

Read more at http://bit.ly/2soNVsY

GMP Expectations for Products Used in Early Phase IND Studies

GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

  • Discussion of the elements found in the guidance document for Phase 1 material
  • What to do at really early stages
  • What about special IND studies?
  • What about preclinical studies?
  • Varying GMP activities that depend upon the nature of the IND product
  • What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
  • What to do about QC activities such as instrument qualification, method validation, and process validation

These guidelines remove some of the problems https://goo.gl/9qYuLa

Investigators to Review CAPA and What you Should do to Prepare

How your company can use that same document to increase the likelihood of a positive outcome during the inspection.

Fremont, CA: Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a webinar on January 11, 2019. The topic of the webinar is “How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare”, and the speaker is Jeff Kasoff

To enroll for this webinar, please visit https://www.compliance4all.com/control/w_product/~product_id=502272LIVE?LI-SEO

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Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company’s CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.

  • Documents Used by FDA Inspectors
  • Investigations Operations Manual (IOM)
    • CAPA Implications
    • Recommended Methods of Compliance for each Requirement
  • CPG Manual 7382.845
    • CAPA Implications
    • Recommended Methods of Compliance for each Requirement
  • QSIT Manual
    • Description of each CAPA Inspectional Objective
    • Recommended Methods of Compliance

Positive outcome during the inspection http://bit.ly/2CUFWK8

Want to Have a More Appealing FDA CFR 21 Part 11? Read This!

The most important ones among these are Computer System Validation, data security, and data backup.

Title 21 CFR Part 11 is one of the sections of the FDA that inspires both awe and respect. Commonly known as 21 CFR Part 11, this section deals with and establishes the criteria for the FDA’s requirements relating to electronic records and electronic signatures (ER/ES). All the requirements which the FDA expects for electronic records and electronic signatures to be considered trustworthy, reliable and equivalent to paper records are set out in this section.

For the FDA to consider electronic records, electronic signatures and handwritten signatures to be on par with handwritten ones and proven for their safety, trustworthiness and authenticity; companies in the designated industries governed by FDA regulations have to meet conditions set out in 21 CFR Part 11. It is only when these conditions are met that the FDA considers these records to have the same effect or worthiness of an actual paper record.

As paper made way for electronic versions with the advent of technology; FDA 21 CFR Part 11 regulations evolved with the intention of helping to overcome some of the obvious drawbacks of paper records:

  • Their potential to be manipulated or forged
  • Their destructibility
  • Lack of authenticity.

FDA 21 CFR Part 11 regulations came into being to give electronic signatures the same effect as those of paper ones. These regulations seek to make the electronic signatures as authentic as the paper records they replace through a set of well-defined scientific means. FDA 21 CFR Part 11 is designed to give regulatory authorities the confidence and scientific validation for this authenticity.

The core areas of 21 CFR Part 11 implementation

21 CFR Part 11 regulations compliance covers three core areas:

Standard Operating Procedures

There are nearly 12 Standard Operating Procedures prescribed in the 21 CFR Part 11 regulations for addressing the company’s IT infrastructure. The most important ones among these are Computer System Validation, data security, and data backup.

System features

21 CFR Part 11 regulations require close to 50 industry-related features that organizations need to implement into their computer systems to be compliant with the regulations.

Computer System Validation

The core of 21 CFR Part 11 regulations is Computer System Validation. The purpose of implementing CSV is to ensure that the FDA has documented evidence that each computer system in the organization carries out exactly what it is expected to and helps users detect and identify errors.

How to make your 21 CFR Part 11 effective

Since implementation of 21 CFR Part 11 is mandatory in the industries for which it is stipulated; it is necessary to those who work in these industries to get a proper and thorough idea of how to properly implement the provisions of this regulation.

Adapt a risk-based approach. This is the foundation to 21 CFR Part 11 implementation 

The basis to effective implementation of 21 CFR Part 11 is to take a risk-based approach to implementation. A risk-based approach should take all the possibilities of risk into the area of electronic signatures and work on ways of countering them. Understanding the risks is the foundation to implementing 21 CFR Part 11 effectively, as it helps to identify areas from which risk could arise to the electronic signatures.

The risk-based approach is not only a very solid means to ensuring the effectiveness of 21 CFR Part 11 regulations; it also prevents the organization from being cited by the FDA, since this is the method the FDA itself suggests and welcomes. It is also extremely useful in making the organization’s computer systems more effective and inexpensive over time.

Train your staff

The key to effective and proper 21 CFR Part 11 implementation is for the organization to let its employees know the importance of this regulation. It is only when employees, as stakeholders in the organization’s growth, are enlightened about the importance of critical regulations such as 21 CFR Part 11 that they understand why they need to implement, what benefit they get out of implementing it, and what they stand to accrue in terms of penalties for lack of implementation that they take a keen interest in its implementation.

Again, training too, is a core FDA requirement. The FDA has laid out clear-cut guidelines of how to train employees for 21 CFR Part 11 implementation and the ways of documenting the training. Organizations that comply with these requirements are less likely to invite FDA actions.

Webinar from Compliance4All on January 9, 2019 on Supervising a Human Error Free Environment

The tools that the speaker will offer at this course can be used for implementation immediately.

Fremont, CA: Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a webinar on January 9, 2019. The topic of the webinar is “Supervising a Human Error Free Environment: You can do a Lot More than you Think”, and the speaker is Ginette Collazo, an Industrial-Organizational Psychologist.

To enroll for this webinar, please visit https://www.compliance4all.com/control/w_product/~product_id=502284LIVE

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In many industries, despite the many advances that have shaped safety standards, human error is still a factor to be reckoned with seriously. Human error, despite taking what one thinks are the best precautions, can lead to loss of quality, processes and production, not to mention the financial one.

What is needed is a comprehensive approach to elimination of human error. While it is acknowledged that human error can never be eliminated, one can take care from many angles and perspectives to minimize it. This should start at the design stage. Good Manufacturing Practices (GMP) regulations need to be implemented in complete faith. The approach should be to identify the root of the human error first and then take the necessary steps to address them.

These should be done in complete sync and harmony with the concerned staff members in charge of safety and in accordance with the principles of GMP. The specific methodologies needed for implementing these will be the essence of the learning this 90-minute webinar will impart.

The speaker will explain strategies with which the unit can use a specific methodology with which to sync and approach issues in GMP related environments that uses a method for correcting, preventing and avoiding recurrence of these issues. She will also describe the practical approaches that can be adhered to while supervising on the floor.

She will also drive home the importance of supervision in reducing and preventing human error and show ways by which to implement metrics that can help track and measure human error rates. The five elements of ensuring a human error-free environment will be discussed at this webinar. The tools that the speaker will offer at this course can be used for implementation immediately.

This webinar will serve the following learning objectives:

  • Understand human error: factors and causes
  • Understand the importance of supervision in creating a high reliable group for both regulatory and business compliance
  • Discuss issues related to supervision and how to avoid traps that will allow errors to occur
  • Identify Root Causes and CAPA associated to supervision.
  • Learn how to measure human error rates at your department and keep track of metrics
  • Identify what I can do to support human reliability at the site.

This course will be beneficial to Supervisors, Managers and Directors, Operations, Manufacturing, Plant Engineering, QA/QC Staff, Process Excellence/Improvement Professionals, Industrial/Process Engineers, Compliance Officers, Regulatory/Legislative Affairs Professionals, and General/Corporate Counsel.

About the speaker:

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.