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.

Supply Chain Integrity and Security

Supply Chain Integrity and Security

The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our attention to supply chain integrity and deal with both security and integrity concurrently.

An Oxford on-line dictionary definition of integrity is “the state of being whole and undivided”. Over the last 40 years, the Pharma supply chain has fragmented to the point where it is a million miles from that state. There are now multiple business models, such as virtual, biotech, specialty Pharma, innovator, generics, biosimilars, etc and a divergence of supporting actors, such a contract manufacturing organizations (CMOs), contract research organizations (CROs), central laboratories, third party logistics providers, pre-wholesalers, wholesalers, specialty pharmaceutical providers (SPPs) etc. As a result, our supply chains have dis-integrated to the point where visibility and accountability have become blurred at the edges – and it is this disintegration that has opened the doors to criminal activity and errors in quality outcomes.

The solution is not an easy one. It requires urgent action to mitigate activities of the ‘bad guys’, together with a longer term approach to ensure the ‘good guys’ get better at building and managing robust supply chains. This can only be achieved by collaboration between regulators, other enforcement agencies, technology providers and the industry itself. Where do we start?

We must initially focus on the end-to-end supply chain in its current state. Chains of custody and ownership must be clearly identified and remediation actions agreed by responsible parties to plug the gaps that currently exist. For example, Quality and technical agreements must become far more ‘process’ orientated so that they become working documents shared between business partners, rather than merely a static list of tick boxes. Change control has to work on upstream and downstream impacts that might affect supply chain integrity and procurement must forge supply agreements that impose obligations for supply chain visibility on prospective partners. This and much more needs to happen and will be discussed in the session.

Then we must turn attention to the building of supply chains for the future – the product development phase. This industry is unique in that the entire supply chain must be registered with competent authorities before approval to sell and post-launch changes have to be approved. This places a great responsibility on getting it right from the start. This is where the opportunity lay for sustainable improvements in the physical architecture of the supply chain and the underpinning management processes and information flows. A foundation for this has already been put in place by the regulators through FDA’s 21st Century Modernization initiative and ICH Q8 – 11 guidelines. The key to translating these initiatives into meaningful supply chain improvements, however, it in understanding the patient value proposition and the organizational/cultural elements that must firstly be in place, and these are explored in some depth.

Why should you attend: The Pharmaceutical supply chain has never been in such turmoil and under such attack from governments and regulators globally. The evidence is stark and mounting. Supply chain shortages in the US have moved even the President to demand urgent remediation; high level congressional committees have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Cargo theft, diversion and counterfeiting have become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly most worrying of all, are the cases where materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death.

Areas Covered in the Session:

  • How to organize for supply chain integrity throughout the product life cycle
  • Current approaches to clamping down on criminal activity in the supply chain
  • Issues causing greatest concern to regulators and how to address them
  • Role of ICH Q8 – 11 in building robust supply chains
  • How the disciplines of procurement and supply chain management (SCM) can be leveraged
  • Role of technology as an enabler

Who Will Benefit:

  • Research chemistry and biochemistry
  • Chemical and biochemical engineering
  • Chemistry, manufacturing, and controls
  • Preclinical Development
  • Clinical Development
  • Regulatory Affairs
  • Quality Assurance

Speaker Profile

Hedley Rees is a practicing consultant, coach and trainer, helping healthcare companies build, manage and continuously improve their clinical trial and commercial supply chains and risk profiles. He has his own company, Biotech PharmaFlow Ltd, based in the UK and handles assignments across the spectrum from top ten Pharma’s through to highly virtual early stage start ups. Prior to this, Hedley held senior supply chain positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. His skill set covers the range of supply chain management processes from strategic procurement, production and inventory control, distribution logistics, information systems and improvement. His specific interest is in driving industry improvements through the regulatory modernization frameworks of FDAs 21st Century Modernization and ICH Q8 – Q10.

Hedley holds an Executive MBA from Cranfield University School of Management and is a corporate member of the Chartered Institute of Purchasing and Supply (MCIPS). He is a member of the UK BioIndustry Association’s (BIA) Manufacturing Advisory Committee and also regularly speaks at international conferences, being co-chair of the 2011 FDA/Xavier University sponsored Global Outsourcing Conference in Cincinnati, October 2 -5. He has published in US and EU pharmaceutical journals and is author of “Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics” published by J. Wiley & Sons, Hoboken, New Jersey.

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200+ followers. WOWWWWWW…

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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!

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Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD.

The Design History File

The history of the Design History File is an interesting one. It evolved out of the FDA’s realization, over time and experience; that the major part of a device’s problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.

cgmpForCombinationProducts

Outstanding characteristics of the Design History File

cgmpForCombinationProducts

What should the Design History File contain?

The DHF should contain the following:

cgmpForCombinationProducts

Now, the Technical File and Design Dossier

In short and simple terms, one can understand the Technical File and the Design Dossier as the EU’s version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.

What should the TF and DD contain?

These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company’s “Declaration of Conformity” for that product:

  • General Information/Product Description/EC Authorized Representative
  • Classification Determination
  • Essential Requirements
  • Risk Analysis
  • Labeling
  • Product Specifications
  • Design Control
  • Clinical Evaluation
  • System Test Reports
  • Functional Bench Testing
  • Lab Testing
  • Sterilization validation (or AAMI TIR 28 Analysis)
  • Packaging Qualifications
  • Manufacturing
  • Sterilization
  • Conclusion
  • Declaration of Conformity
  • Appendix

Differences between the Technical File and Design Dossier

At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices

While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.

 

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FDA Requirements for ensuring Premarketing Clinical Trial Safety

FDA Requirements for ensuring Premarketing Clinical Trial Safety 2

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks and benefits that go into the clinical trial, and errors need to be identified and corrected at this stage. Wrong data could lead to disastrous consequences for the study, the subjects that are part of it, the organization and eventually, patients.

Basic nature of FDA requirements for premarketing clinical trial safety

FDA Requirements for ensuring Premarketing Clinical Trial Safety 1

The FDA has a set of requirements for premarketing clinical trial safety, but these are mostly informal and loose. They are more of an advisory nature than being stringent regulatory requirements that are legally enforceable. Most FDA guidance is on a case-by-case nature.

FDA Requirements for ensuring Premarketing Clinical Trial Safety 4

Basically, the FDA’s guidance is based on its working with large to very large clinical trials. It has thus far not seriously considered working with small groups for assessing premarketing clinical trial safety. At its barest, the FDA seeks to:

  • Advise sponsors or organizations undertaking the clinical trial about ways by which their data collection can be simplified so as to ensure that it is neither too huge nor too small, and should lead to giving insights about the drug’s safety. Essentially, the FDA guideline on premarketing clinical trial safety seeks to prevent sponsors from collecting data that is not relevant.
  • Get sponsors to consult the FDA’s review division for its premarketing clinical trial safety.
The FDA has different requirements for different kinds of studies that relate to clinical trials. For example:

premarketingClinicalTrialSafety

The FDA’s requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products

The FDA's requirements for non-IND Foreign Clinical Studies 2

that are permitted under this system of foreign clinical studies include:

  • A human drug
  • A biological drug
  • A medical device

The guidelines for foreign clinical studies requirements

The guidelines under which the FDA accepts medical products for approval when they are the result of foreign clinical studies are spelt out in various sections of 21 CFR.

Any foreign clinical study has to be meet requirements of 21 CFR Part 312or 21 CFR Part 812, which relate to studies conducted under an Investigational New Drug Application (NDA) or Investigational Device Exemption (IDE) respectively, just the same way in which American companies too have to

In case a foreign clinical study is not conducted under an IND; the FDA will still accept it, so long as it fulfills the ethical principles set out in the Declaration of Helsinki, or is in accordance with the laws of the respective country from which the study originates, based on whichever of these two offers stronger protection of the subjects of the study.

Highlights of the Helsinki Declaration

The FDA's requirements for non-IND Foreign Clinical Studies 1

The World Medical Association adapted the Helsinki Declaration from the time it was passed in 1964. In 1975, given the popularity of the Declaration in guaranteeing humane protection of human subjects in a clinical study; the FDA adapted the principles of the Helsinki Declaration as the basis for accepting non-IND compliant drugs. This Declaration has been revised a few times, although the FDA is yet to include the latest of these, that of October 2000, into its regulations.

Points of significance

Export, Import and Trade Compliance Principle – an understanding

Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an understanding of the government’s outlook and stance in these matters.

There are two aspects of the export, import and trade compliance principle:

export-import-and-trade-compliance-principle
General export, import and trade compliance principles

 

As can be understood from the description of the concept of export, import and trade compliance principle; export, import and trade compliance principles laid out by the government and requiring compliance with their guidelines are fixed. Organizations cannot manipulate or tamper them. Doing so, naturally, invites penalties.

However, the export, import and trade compliance principles set out by individual companies are conditioned by their own ethics and culture. These are a reflection of how organizations carry out their export, import and trade compliance principle, something that they themselves have laid out.

export-import-and-trade-compliance-principleAdapting the right export, import and trade compliance principle and implementing it is a reflection of how well the organization understands the business and the market and how well it is able to maintain its integrity among its circles. Needless to say, an organization that says one thing and does another is seen in a negative light by its peers.

 

Organizations specialize in helping to implement export, import and trade compliance principle

 

Just as there are many organizations which are in the business of ensuring many complex fields such as governance, risk and compliance (GRC) and technology compliance; several organizations specialize in helping organizations implement both the export, import and trade compliance principle as laid out by the government, and their own export, import and trade compliance principles.

export-import-and-trade-compliance-principleWhether an organization gets its export, import and trade compliance principle implemented through an outside, third party or does it on its own; there is no escaping the fact that export, import and trade compliance principle is something that is mandatory to state and implement accordingly.

Overlaps and alignments of organizational, governmental and trade bloc requirements

export-import-and-trade-compliance-principleEven when organizations draw up their own export, import and trade compliance principle; they are bound to include the latest and relevant regulations, policies and procedures as laid out by the government. Many internal export, import and trade compliance principles and external (those prescribed and required by the government) overlap on many occasions with those of trade blocs such as the North American Free Trade Agreement (NAFTA), European Union Preferential Trade Agreement, Association of Southeast Asian Nations (ASEAN), Mercosur, etc. Export, import and trade compliance principles from these different sources should align with each other.

Reasons for export, import and trade compliance principle implementation

 

The export, import and trade compliance principles laid out by respective governments are in place because of many important reasons.

 

export-import-and-trade-compliance-principle