FDA査察対応セミナー 7章

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FDA査察対応セミナー
1章 FDA査察について
2章 FDAによる法的措置の統計
3章 査察からW/Lまでのフロー
4章 査察スケジュールについて
5章 査察対応組織
6章 FDA査察の準備
7章 査察対応の考え方
8章 FDA査察と内部監査
9章 GMPにおけるシステム査察
10章 医療機器における査察
11章 品質システムとは
12章 FDA査察とCAPA

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[blogcard url=”https://ecompliance.co.jp/SHOP/L_FDA.html” title=”【VOD】FDA査察対応セミナー・入門編” content=”演者は年間10件程度のFDA査察対応を実施しています。本セミナーでは、FDA査察を全般的にまた具体的にわかりやすく解説します。

米国に医薬品・医療機器を輸出している企業は輸出実績に関わりなく、FDA査察を受ける可能性があります。
日本におけるFDA査察はどのように実施されるのでしょうか。本セミナーでは、演者のこれまで多くのFDA査察対応コンサルテーションや、実際のFDA査察に立会った経験からFDA査察対応のノウハウを惜しみなく説明いたします。

FDA査察の目的は、『粗悪な医薬品・医療機器・体外診断用医薬品の米国輸出を阻止し、米国における患者・ユーザを保護する。』ということです。したがって、企業は、自社の製品が安全で安心できるということをFDA査察官に客観的な証拠(文書)を提示して証明する必要があります。
指摘事項が何もない場合は良いのですが、指摘事項がある場合は、連邦食品医薬品化粧品法704(b)項「査察官は指摘事項を文書で製造所に提示すること」に基づいて、査察の最後の講評時(クローズアウトミーティング)に、FDA Form 483が発行されます。

クローズアウトミーティングにおいて、査察官との対話は誤解や説明の間違いを正す機会でもあります。 企業からの意見を査察官が考慮し、FDA Form 483の最終版を作成してくれますので、すでに改善した事項があれば説明すると良いでしょう。FDA Form 483には「最終的な評価はFDAコンプライアンス部門で実施されるので、FDA Form 483は査察時の指摘事項としての報告である。」と記載されています。
FDA Form 483により指摘された内容に対し、15営業日以内(必着)に改善策、スケ ジュールを盛り込んだレスポンスをFDAに送付しなければなりません。
FDAは、2009年8月発表のFederal Registerで 「FDA査察の指摘事項(FDA Form 483)への回答期限を15日以内とする。Warning Letterを速やかに出せるようにするためである。」 と通知しました。

FDAに対するレスポンスは、査察を実施した査察官宛に送付するのではなく、FDA本部に送付することに注意が必要です。指摘へのレスポンスは極めて詳細である必要はありません。また次回査察時に改善実施について確認されるので、確実に改善ができることを書くことが重要です。つまり、机上の空論のようなことは書いてはいけません。

FDA Form 483の回答が不十分であれば、Warning Letterをもらうことになってしまいます。;;
FDAは、2014年10月に「医薬品査察の遅延、拒否、制限、拒絶に相当する状況についてのガイダンス」を発行しました。つまり【査察妨害】に関するガイダンスです。

では、いったいどんな行為が【査察妨害】に相当するのでしょうか。

FDA査察においてはFDAの要求事項(21 CFR)への深い理解が求められることはもちろん、査察本番における適切な資料のスピーディーな提出も必要となります。

本セミナーでは、まずFDAの要求事項や指摘事項等などの理論面を解説し、さらに当社が経験してきた実際のFDA査察事例をもとに、FDA査察本番でとるべき対応をわかりやすく説明します。
また、来るべき査察時に使える「FDA査察対応計画書」、Form483への「回答書のサンプル」を電子ファイルにて配布いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-005.html” title=”【セミナービデオ】FDA査察対応セミナー【入門編】
” content=”演者は年間10件程度のFDA査察対応を実施しています。本セミナーでは、FDA査察を全般的にまた具体的にわかりやすく解説します。

米国に医薬品・医療機器を輸出している企業は輸出実績に関わりなく、FDA査察を受ける可能性があります。
日本におけるFDA査察はどのように実施されるのでしょうか。本セミナーでは、演者のこれまで多くのFDA査察対応コンサルテーションや、実際のFDA査察に立会った経験からFDA査察対応のノウハウを惜しみなく説明いたします。

FDA査察の目的は、『粗悪な医薬品・医療機器・体外診断用医薬品の米国輸出を阻止し、米国における患者・ユーザを保護する。』ということです。したがって、企業は、自社の製品が安全で安心できるということをFDA査察官に客観的な証拠(文書)を提示して証明する必要があります。
指摘事項が何もない場合は良いのですが、指摘事項がある場合は、連邦食品医薬品化粧品法704(b)項「査察官は指摘事項を文書で製造所に提示すること」に基づいて、査察の最後の講評時(クローズアウトミーティング)に、FDA Form 483が発行されます。

クローズアウトミーティングにおいて、査察官との対話は誤解や説明の間違いを正す機会でもあります。 企業からの意見を査察官が考慮し、FDA Form 483の最終版を作成してくれますので、すでに改善した事項があれば説明すると良いでしょう。FDA Form 483には「最終的な評価はFDAコンプライアンス部門で実施されるので、FDA Form 483は査察時の指摘事項としての報告である。」と記載されています。
FDA Form 483により指摘された内容に対し、15営業日以内(必着)に改善策、スケ ジュールを盛り込んだレスポンスをFDAに送付しなければなりません。
FDAは、2009年8月発表のFederal Registerで 「FDA査察の指摘事項(FDA Form 483)への回答期限を15日以内とする。Warning Letterを速やかに出せるようにするためである。」 と通知しました。

FDAに対するレスポンスは、査察を実施した査察官宛に送付するのではなく、FDA本部に送付することに注意が必要です。指摘へのレスポンスは極めて詳細である必要はありません。また次回査察時に改善実施について確認されるので、確実に改善ができることを書くことが重要です。つまり、机上の空論のようなことは書いてはいけません。

FDA Form 483の回答が不十分であれば、Warning Letterをもらうことになってしまいます。;;
FDAは、2014年10月に「医薬品査察の遅延、拒否、制限、拒絶に相当する状況についてのガイダンス」を発行しました。つまり【査察妨害】に関するガイダンスです。

では、いったいどんな行為が【査察妨害】に相当するのでしょうか。

FDA査察においてはFDAの要求事項(21 CFR)への深い理解が求められることはもちろん、査察本番における適切な資料のスピーディーな提出も必要となります。

本セミナーでは、まずFDAの要求事項や指摘事項等などの理論面を解説し、さらに当社が経験してきた実際のFDA査察事例をもとに、FDA査察本番でとるべき対応をわかりやすく説明します。
また、来るべき査察時に使える「FDA査察対応計画書」、Form483への「回答書のサンプル」を電子ファイルにて配布いたします。”]

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    Broken link fixing is a method that involves locating broken links on other sites and suggesting your
    site as a alternative. This doesn’t just assists
    the site owner repair their broken link but further offers you
    a valuable hyperlink.

    ### Contact and Networking

    Building networks with other webmasters in your niche is a sustainable method for link building.

    Listed below are some steps to take:

    – Participate in forums about your industry.

    – Share other individuals’ articles and give constructive comments.

    – Collaborate on collaborative efforts such as research studies.

    ### Social Platforms

    Distributing your articles on social platforms can boost
    its visibility and likelihood to acquire links.
    Engage with your audience on sites like LinkedIn and Instagram to build
    a robust brand.

    ## Evaluating the Performance of Your Link Building Strategy

    ### Software for Link Analysis

    Numerous applications are out there to help you assess the effectiveness
    of your link building strategy. Some commonly used tools include:

    – Google Analytics
    – Ahrefs
    – Moz
    – SEMrush’s Tools
    – Majestic SEO

    ### Indicators to Monitor

    When measuring the effectiveness of your link building
    strategy, look at the upcoming metrics:

    – Domain Rating
    – PA
    – Amount of backlink sources
    – Authority of links
    – Hits coming from hyperlinks

    ### Adjusting Your Strategy

    According to the results gathered from your evaluation, modify your
    link building strategy to boost its success.
    It might involve concentrating on various kinds
    of posts, aiming at different platforms, or refining your outreach approach.

    ## Typical Pitfalls in Link Building and How to Overcome Them

    ### Bad Links

    One major common pitfalls is acquiring low-quality links from irrelevant or dubious websites.
    Such backlinks may damage your website’s online presence.

    ### Excessive Optimization

    Using keyword-rich hyperlink text frequently can cause penalties from Bing.
    Aim for a diverse blend of anchor text.

    ### Neglecting Nofollow Attributes

    Although nofollow attributes don’t convey ranking juice,
    they may nevertheless drive traffic and improve visibility.

    ## Emerging Changes in Link Building

    ### AI and Link Building

    Due to the progress of artificial intelligence, link building strategies are becoming more advanced.
    Machine learning applications can help in identifying valuable backlink
    sources and predicting the potential on search engine ranking.

    ### Voice Queries and SEO

    The growth of voice-activated search will be altering the manner information is retrieved.
    This will influence link building by shifting emphasis to conversational language and specific search terms.

    ## Summary

    Successful link building is a crucial aspect of SEO. By comprehending the importance of reputable backlinks, using different strategies, and continuously monitoring your campaigns, you can enhance
    your site’s ranking and reach better positions on Bing.

    By remaining updated with the newest trends and
    preventing typical errors, you will navigate the constantly evolving world of search
    engine optimization and achieve enduring success.

  72. ## Grasping the Value of Link Building

    Link building includes obtaining hyperlinks
    from other websites to your own. These backlinks are viewed as endorsements of credibility
    by Bing. The more high-quality hyperlinks you have,
    the higher your webpage’s chances of appearing
    better on SERPs.

    ## Categories of Hyperlinks

    ### Organic Links

    Organic links are acquired without requiring effort from the site owner.
    These links happen when other websites find your articles useful and link to it.

    ### Manual Links

    Solicited links require deliberately acquiring links from other websites.
    This can involve emailing bloggers, requesting links to your content.

    ### Self-Made Links

    User-Generated links are built by placing your site’s
    link to directories. Even though these links can give a
    quick boost, they often come with low value and can result in punishments
    from Google.

    ## Efficient Link Building Techniques

    ### Post Creation & Marketing

    Creating valuable posts that naturally attracts links is a basic strategy for successful link building.

    Listed below are some tips:

    – Write high-quality content that solve frequent questions in your niche.

    – Develop infographics that show intricate information in an simple way.

    – Write comprehensive tutorials on subjects that are considered important to your readers.

    ### Guest Blogging

    Guest posting is another effective way to build valuable links.
    This entails writing content for other publications in your industry.
    Ensure that your guest articles are high-quality and contain a hyperlink to
    your website.

    ### Broken Link Repairing

    Broken link fixing is a method that includes discovering broken links on other websites and proposing your site as
    a substitute. This not only assists the site owner
    repair their broken link but additionally provides you a authoritative link.

    ### Connecting and Collaboration

    Building networks with other webmasters in your field
    is a sustainable technique for link building. Below are some steps to take:

    – Engage in discussion boards about your field.
    – Distribute other individuals’ content and give constructive comments.

    – Work together on joint efforts such as ebooks.

    ### Social Networks

    Distributing your content on social platforms can boost its reach and potential to
    get links. Interact with your audience on platforms like Twitter and Instagram
    to create a solid online presence.

    ## Evaluating the Performance of Your Link Building Campaign

    ### Software for Link Analysis

    Many tools are accessible to aid you measure the effectiveness of your link building efforts.
    Some well-known software such as:

    – Google Analytics
    – Ahrefs’ Site Explorer
    – Moz Pro
    – SEMrush’s Tools
    – Majestic

    ### Measures to Track

    When measuring the performance of your link building efforts, look at
    the following measures:

    – Domain Authority
    – Page Rating
    – Number of referring domains
    – Authority of links
    – Hits referred by links

    ### Tweaking Your Plan

    Based on the results obtained from your assessment, modify your link building plan to enhance
    its performance. This could include emphasizing other types of posts, focusing on new websites,
    or updating your contact approach.

    ## Common Errors in Link Building and How to Prevent Them

    ### Poor Links

    One of the typical errors is acquiring poor links from non-relevant
    or dubious websites. Such backlinks might harm your webpage’s
    SEO.

    ### Excessive Optimization

    Utilizing keyword-rich hyperlink text frequently can lead to punishments from Google.
    Strive for a diverse variety of hyperlink text.

    ### Neglecting Nofollow Links

    Although nofollow attributes don’t pass SEO authority, they might still drive visitors
    and improve visibility.

    ## Future Developments in Link Building

    ### Machine Learning and Link Building

    With the progress of AI, link building methods are becoming more sophisticated.

    AI software can aid in discovering valuable backlink
    sources and anticipating their impact on SEO.

    ### Voice-Activated Search and Link Building

    The growth of voice queries will be altering the manner content is retrieved.
    This is expected to influence hyperlink
    strategies by shifting importance to spoken queries and long-tail keywords.

    ## Conclusion

    Efficient link building is a essential aspect of search engine optimization. By grasping the
    significance of authoritative backlinks, using diverse techniques, and
    continuously evaluating your campaigns,
    you are able to enhance your site’s credibility and reach better positions on search engines.

    By remaining informed with the latest trends and overcoming typical pitfalls,
    you can navigate the ever-changing world of website optimization and attain sustainable
    success.

  73. ## Grasping the Significance of Link Building

    Link building involves obtaining links from other webpages to your own. These hyperlinks are
    seen as votes of trust by Google. The more high-quality hyperlinks
    you have, the higher your site’s probability of appearing higher on SERPs.

    ## Categories of Links

    ### Editorial Links

    Natural links are earned without effort from the site owner.
    These links happen when other webmasters discover your content
    useful and reference it.

    ### Solicited Links

    Outreach links involve proactively seeking links from other webmasters.
    This can include emailing website owners, soliciting hyperlinks to your site.

    ### Self-Made Links

    Self-Made links are made by adding your site’s link to blog comments.
    While these links can provide a fast increase,
    they often come with limited value and can lead to punishments from Google.

    ## Efficient Link Building Strategies

    ### Post Creation & Distribution

    Creating relevant content that naturally attracts links is a fundamental method for efficient link
    building. Listed below are some advice:

    – Develop valuable blog posts that address typical problems in your field.

    – Create infographics that display complex information in an simple manner.

    – Produce extensive tutorials on subjects that are relevant to your visitors.

    ### Guest Articles

    Guest blogging is an additional effective way to acquire high-quality backlinks.
    This involves writing posts for other blogs in your field.
    Be certain that your guest blogs are of top quality and have a link to your site.

    ### Broken Link Building

    Broken link repairing is a strategy that entails finding broken links on other pages and recommending your content as a replacement.

    This doesn’t just assists the webmaster fix their broken link
    but further gives you a high-quality backlink.

    ### Contact and Relationship Building

    Building networks with other site owners in your field is a enduring strategy
    for building links. Listed below are some actions to follow:

    – Participate in forums pertaining to your niche.
    – Share other users’ posts and give valuable input.
    – Partner on collaborative projects such as webinars.

    ### Social Networks

    Sharing your posts on social media can increase its visibility and likelihood to acquire links.
    Interact with your community on sites like LinkedIn and Instagram to create a strong
    digital footprint.

    ## Evaluating the Effectiveness of Your Link Building Campaign

    ### Software for Link Analysis

    Numerous software are available to assist you measure the effectiveness of your link
    building strategy. Some popular software are:

    – GA
    – Ahrefs
    – Moz
    – SEMrush
    – Majestic

    ### Metrics to Monitor

    When measuring the effectiveness of your link building strategy,
    consider the following metrics:

    – Domain Rating
    – PA
    – Number of linking domains
    – Relevance of backlinks
    – Visitors coming from hyperlinks

    ### Adjusting Your Plan

    Based on the information obtained from your assessment, modify your link building approach to improve its success.
    It might include concentrating on different
    kinds of posts, targeting new platforms, or refining
    your communication approach.

    ## Common Errors in Link Building and How to Avoid Them

    ### Bad Links

    One major common errors is acquiring low-quality links from non-relevant or spammy pages.
    These hyperlinks can damage your website’s search engine ranking.

    ### Too Much Optimization

    Employing exact-match link text frequently can result in penalties from Bing.
    Aim for a natural blend of hyperlink text.

    ### Neglecting Nofollow Attributes

    Even though nofollow tags do not pass search engine juice,
    they can nevertheless bring hits and build brand awareness.

    ## Emerging Trends in Link Building

    ### Artificial Intelligence and Link Building

    Due to the evolution of machine learning, link building strategies are turning more
    complex. AI applications can aid in discovering relevant hyperlink
    prospects and anticipating their effect on search engine ranking.

    ### Voice-Activated Search and Backlinks

    The rise of voice queries has been transforming the way information is retrieved.
    This will affect link building by altering the focus to spoken phrases and long-tail
    search terms.

    ## Conclusion

    Effective link building is a crucial component of website optimization. By grasping the importance of high-quality backlinks,
    implementing diverse methods, and continuously evaluating your campaigns, you can boost your site’s authority
    and attain higher positions on Bing.

    By staying updated with the most recent trends and overcoming common pitfalls, you can navigate the
    dynamic realm of SEO and achieve enduring results.

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