Recalls of Therapeutic Goods
Course duration: Allow 3 to 5 hours to complete this course.
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Recalls of Therapeutic Goods
Requirements for recalls of therapeutic products
- At times, serious quality defects (deviations or non-conformances) are discovered after a medicinal product is released to the market.
- Some of these quality defect scenarios will necessitate a recall.
- There are numerous risks with defective products and/or with recall implementation (risks to patients/consumers, the company, its distributors and its employees).
- Recalls of therapeutic products must therefore be carefully managed, in accordance with internal recall procedures, PIC/S GMP guidelines, and national laws, in order to minimise risks to patients and consumers (or with veterinary medicines, to minimise risks to animals/pets).
GMP regulations for recalls of medicines & medical devices
Preparing your team to implement recalls of therapeutic goods is an important component of your Pharmaceutical Quality System (PQS) and personnel training program for GMP compliance.
- Even when a recall of your product type is unlikely, your team must be prepared to manage a recall situation or other product defect crisis.
- When a recall is called for:
- GMP employees must know who to contact (internally and externally), and when.
- Your recall procedures must be up-to-date and effective.
- Recall procedures must include in-hours and out-of-hours communication protocols and contact information.
- Public notification protocols & national laws must be followed in each distribution region/Regulatory Authority jurisdiction.
- Not all product types are handled the same way; recall classes have an impact on recall procedures (e.g. Class I, Class II, Class III recalls).
Pharmaceutical Quality System (PQS/QMS): understanding recall procedures
Completing this Certificate GMP training course in product recall processes/recall management will help your team learn what’s generally expected by Regulators in terms of:
- Deviations & quality defect investigations
- Risk assessments and risk mitigation strategies
- Safety alerts or field corrections versus product removals (recalls)
- Recall communications/public announcements
- Recall recordkeeping
- CAPA expectations
- Recall reviews
This online GMP training course will answer common FAQs about recalls of therapeutic goods (medicines and medical devices). The article on benefits/regulatory expectations for conducting periodic mock recalls of medicines and medical devices is also recommended reading.
Pharmaceutical Product Recall Guidelines
FAQs for recalling medicines, medical devices, veterinary medicines & other therapeutic goods, answered in this course include:
- What are the regulatory requirements for implementing recalls of therapeutic goods?
- What steps are involved in planning and implementing a recall?
- What types of quality defects (or suspected tampering) could lead to a recall scenario?
- Do recall procedures vary for different types of pharmaceutical products or implanted medical devices?
- Do you need to notify the Regulatory Authority before you take a recall action or do you notify customers first?
- Will your recall lead to supply chain shortages that the Regulatory Authority needs to consider?
- Does the Consumer Protection Agency need to be involved?
Learn about recalls of products in a GMP environment in this comprehensive online course.
This fully online Certificate GMP training course covers product recalls of various pharmaceutical product types and medical devices. In addition to the latest PIC/S guidance for Recalls and Rapid Alerts, this course includes recall guidance from several Competent Authorities, as well as product-specific recall guidance publications.
To order, simply scroll up and “add to cart”, complete your purchase, and then check your email system for an email with your log in details (search all mailboxes).
Recall guidance in this course includes PIC/S PE 009-16 as well as guidance from Regulatory Authorities such as:
- EU EMA
- US FDA
- Australian TGA (UPRTG)
- UK MHRA
Purchase this course online, and start your training today! Be sure to read the FAQs so you know what to expect.
This course explores PIC/S regulatory guidance and regional Regulatory Authority expectations for planning and implementing product recalls of therapeutic products. It should be part of your GMP compliance training program.
What’s included in the Recalls of Therapeutic Products training course?
This online Certificate training course includes the following information:
- Product-specific recall guidance
- Including requirements for recalling biological products and/or blood-based products or plasmas
- Recall guidance based on recall classification (recall class), type, and level
- US FDA guidance on recalls of therapeutic goods – 21 CFR, Chapter 7 (Enforcement policy)
- FDA Guidance for the industry – Product Recalls, Including Removals and Corrections
- Guidance for recalls or corrections of Medical Devices as in 21 CFR Part 806, 21 CFR Part 810
- 21 CFR Part 211 for Finished Pharmaceutical Products
- Examples of regulatory guidance for recall notifications and rapid alerts:
- PIC/S recall guidance
- Rapid Alert Systems guidance
- Crisis management in situations of tampering or counterfeit products
- Regional guidance from various Regulatory Authorities including the EMA, FDA, MHRA, and TGA
- Other helpful recall guidance publications discussed in this course include:
- The TGA’s URPTG (Uniform Recall Procedure for Therapeutic Goods)
- Example guidelines from Regulatory Authorities such as the FDA, TGA, MHRA, EU/EMA
This recalls course is suitable for a worldwide audience.
The course includes PIC/S guidance (global standards for managing product recalls). It also includes guidance specific to the US (FDA recall guidance), Australia (TGA recall guidance), and the other regulators listed previously.
This certificate GMP training course for Recalls of Therapeutic Products is ideally suited for:
- Business Owners and Operations Managers
- Pharmaceutical industry personnel
- Medical device manufacturing personnel
- Medical device quality assurance teams and device maintenance or testing managers
- Auditors and GMP Compliance Inspectors
- Quality Team Leaders and Quality Management Associates
- The Authorised Person (also known as ‘Responsible Person’ or ‘Qualified Person’ responsible for batch certification and release)
- Pharmacovigilance teams or contractors
- Logistics Managers including Pharmaceutical Distribution Contractors
- Other personnel working in a GMP/cGMP environment
- Product managers
- Laboratory testing personnel
- Operations Managers/Department Managers
- Customer service/sales representatives
- Administrative officers and contact personnel
- Distribution/logistics personnel
Earn your GMP training certificate in “Recalls of Therapeutic Goods” to add to other GMP education topics including deviations management, complaints management, and CAPA!
This newly-released Recalls of Therapeutic Products training course is ideal to complete along with the Complaints Management course, the Deviations and Non-Conformances management course, and the CAPA systems training course.
Learn what’s required for therapeutic goods product recall procedures!
GMP compliance training course on product recalls – available online!
Topics covered in this online GMP compliance course on Recalls of Therapeutic Products include:
- How do product recall procedures fit into a Pharmaceutical Quality System (PQS) or other Quality Management System (QMS)?
- Which scenarios can lead to recalls of therapeutic products such as pharmaceuticals, diagnostic kits, or medical devices?
- Are most therapeutic product recalls voluntary (initiated by the manufacturer)?
- Or are they mandated by the Regulatory Authority, such as the TGA or FDA?
- What’s required when planning for a recall for a medicine or medical device?
- What do regulators expect in terms of ‘mock recalls’ (simulated recalls)?
- Who do you notify, and when, if you detect a product defect that poses a serious risk to public health and safety (or animal health and safety?) When is a media release required?
- And are there different recall requirements for specific types of products such as vaccines, blood products, medical devices, heart devices (pacemakers), and other therapeutic goods?
- What do you need to submit to the Competent Authority/Regulatory Authority when preparing a product recall action plan?
- Do consumer protection agencies need to be involved?
- Which product quality issues may necessitate a recall? (e.g. defects, complaints, out-of-specification results, etc.)
GMP industry training experts
The course provides learners with PIC/S cGMP guidance including internationally accepted standards and regulatory guidance for managing recalls due to product defects or other serious quality issues.
- This is one of our many GMP education topics eLearning courses available 24/7.
- It is a follow-up course to the cGMP deviations management course; the Complaints Management course, and the CAPA course for GMP personnel and Managers.
- Click here for a list of face-to-face courses delivered via Zoom, including CAPA (onsite training of large groups of personnel may also be available, where feasible).
Alternatively, you can purchase a single course (such as this Product Recalls Course), or just a few of the courses you need for ‘just in time’ learning.
- Note: one learner, one cGMP course completion Certificate per course purchase.
- The learner will have 12 months’ access to the course and a downloadable online CAPA training certificate of completion.
Do you need to train your personnel to follow SOPs for CAPA?
- If you need to train large numbers of employees on CAPA, complaints management, and/or Deviations and Non-Conformances Management in a GMP environment, contact us for a quote.
- You can alternatively order discounted GMP education topics/GMP training bundles.
- If you’re purchasing this course for yourself and your future career in the pharmaceutical industry, consider the customisable 4-bundle course packages.
Note: All course prices are in US dollars.
Bundled training options let you ‘mix and match’ standard courses and/or assign courses to different employees when required (enabling ‘just in time’ GMP training). All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.
About this Pharmaceutical Industry training course
- Completion of any of our online GMP courses will enable you to print your GMP topic Course Certificate — and earn a Credly badge for your social media channels.
- You can also attach your Certificate of Completion to your CV when applying for jobs in the pharmaceutical sector.
How to complete this course.
- Add the course to your basket and complete your purchase.
- Remember, the course fees are listed in US Dollars.
- Check your emails (all folders) for log-in instructions approximately 5 to 10 minutes after your order is finalised.
- Be sure to search for/add the following domains to your safe sender’s list: “@onlinegmptraining.com” and @pharmout.net”.
One user/per licence purchase (12 months’ access)
- This cGMP regulations compliance training course is available online, one user per licence.
- Course completion provides learners with a foundational understanding of planning and implementing a product recall including recordkeeping, and Manufacturer and Sponsor responsibilities in GMP environments.
GMP Training Course Benefits:
- The training course will assist personnel to understand Regulatory expectations for therapeutic product recalls, including documentation requirements, investigations, root cause analysis, CAPA, and customer and supplier notification requirements.
- This course will assist personnel who may be involved with product recalls to understand regulatory expectations; and can help you establish a more GMP compliant culture in your organisation.
Allow 3 to 5 hours to complete this Recalls of Therapeutic Products eLearning training course including the online Final Assessment.
Other recommended courses include:
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Are your SOPs for deviation management out of date?
- Click here for Deviation Management examples and templates.
- Technical writers for SOPs are also available as PQS/QMS consultants/writers.