This document provides an overview of recall procedures and classifications. It discusses when recalls are initiated, the different types of recalls (voluntary vs. non-voluntary), and factors considered in recall classification such as risk to patient health and extent of quality defects. Recall classification systems from the UK Medicines and Healthcare Products Regulatory Agency and US FDA are presented, categorizing recalls from Class I (most serious) to Class III based on health hazard. Scenarios exploring medication mix-ups are analyzed to demonstrate how recalls would be classified.
Ich q3d for elemental impurities risk evaluationAzierta
Directive ICH Q3D aims to limit the presence of potentially toxicelemental impurities (also known as heavy metals) in pharmaceutical products intended for human use.
This directive is linked to changes in the pharmacopoeias (Ph.Eur. & USP) with the introduction of new, safer, more selective and precise analytical methods with greater reproducibility and better recovery.
Likewise the directive establishes the toxicity limits of potentially present elements.
Directive ICH Q3D sets out a list of 24 elements divided into four categories (classes 1, 2A, 2B and 3), in relation to their toxicity and their probability of occurrence and the maximum permitted daily exposure (PDE: Permitted Daily Exposure) for each impurity according to the administration route (µg / day).
Ich q3d for elemental impurities risk evaluationAzierta
Directive ICH Q3D aims to limit the presence of potentially toxicelemental impurities (also known as heavy metals) in pharmaceutical products intended for human use.
This directive is linked to changes in the pharmacopoeias (Ph.Eur. & USP) with the introduction of new, safer, more selective and precise analytical methods with greater reproducibility and better recovery.
Likewise the directive establishes the toxicity limits of potentially present elements.
Directive ICH Q3D sets out a list of 24 elements divided into four categories (classes 1, 2A, 2B and 3), in relation to their toxicity and their probability of occurrence and the maximum permitted daily exposure (PDE: Permitted Daily Exposure) for each impurity according to the administration route (µg / day).
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
This webinar will discuss appropriate quality attributes for different raw material uses, present strategies to support identification, selection and risk assessment of raw materials, and highlight the importance of regulatory documentation.
Recent and continuing regulatory improvements require drug manufacturers to assess and mitigate risk throughout their entire processes. This includes raw materials used at every stage of manufacturing and clinical phases. Current regulatory guidelines and industry standards clearly define quality requirements for raw materials that are incorporated into, or used close to, final drug product, for example active ingredients and excipients. However, no such clear standards are defined for chemicals used earlier in the process, such as in upstream bioprocessing, early chemical synthesis stages, or clean-in-place. The absence of such standards presents a challenge to efficiently and effectively source raw materials with appropriate supply chain transparency and control, accompanied by the necessary supporting documentation.
In this webinar, you will learn:
• Strategies to support identification, selection, and risk assessment of raw materials throughout the manufacturing process
• Appropriate quality attributes for different raw material uses
• The importance of quality and regulatory documentation provided by the supplier
Risk-based Approach to evaluate Nitrosamines and Elemental Impurities from Si...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3usdjx7
Nitrosamines and elemental impurities are now a concern for regulatory agencies. A key issue related to plastic single-use systems (SUS) is potential leachables from contact materials. For SUS it’s essential to evaluate leachables as well as nitrosamines and elemental impurities risks.
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
• Understand of the potential of nitrosamine contamination
• Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
• See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Presented by: Janmeet Anant
Senior Regulatory Consultant
Presented to a small group of working professionals (Constructed from different documents of FDA, ISPE etc. available on public domain) - Personal point of view
Understanding Pharmacology for Health Professionals 4th Edition Turley Test BankEmilyVaughanss
Full download : https://alibabadownload.com/product/understanding-pharmacology-for-health-professionals-4th-edition-turley-test-bank/ Understanding Pharmacology for Health Professionals 4th Edition Turley Test Bank , Understanding Pharmacology for Health Professionals,Turley,4th Edition,Test Bank
Number 13 of this series of 15 relates to nursing students learning how, when, what, dose, etc. to give medications. Patients trust you as you are the Patient's Advocate. This can seem overwhelming at first, but you will get to the point it is second nature. Most importantly, ASK if you are unsure of the dose, medication, contraindicators, allergies, etc. DO NOT allow yourself to be intimated by anyone. This is your patient and you must provide the absolute best nursing care.
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
This webinar will discuss appropriate quality attributes for different raw material uses, present strategies to support identification, selection and risk assessment of raw materials, and highlight the importance of regulatory documentation.
Recent and continuing regulatory improvements require drug manufacturers to assess and mitigate risk throughout their entire processes. This includes raw materials used at every stage of manufacturing and clinical phases. Current regulatory guidelines and industry standards clearly define quality requirements for raw materials that are incorporated into, or used close to, final drug product, for example active ingredients and excipients. However, no such clear standards are defined for chemicals used earlier in the process, such as in upstream bioprocessing, early chemical synthesis stages, or clean-in-place. The absence of such standards presents a challenge to efficiently and effectively source raw materials with appropriate supply chain transparency and control, accompanied by the necessary supporting documentation.
In this webinar, you will learn:
• Strategies to support identification, selection, and risk assessment of raw materials throughout the manufacturing process
• Appropriate quality attributes for different raw material uses
• The importance of quality and regulatory documentation provided by the supplier
Risk-based Approach to evaluate Nitrosamines and Elemental Impurities from Si...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3usdjx7
Nitrosamines and elemental impurities are now a concern for regulatory agencies. A key issue related to plastic single-use systems (SUS) is potential leachables from contact materials. For SUS it’s essential to evaluate leachables as well as nitrosamines and elemental impurities risks.
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
• Understand of the potential of nitrosamine contamination
• Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
• See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Presented by: Janmeet Anant
Senior Regulatory Consultant
Presented to a small group of working professionals (Constructed from different documents of FDA, ISPE etc. available on public domain) - Personal point of view
Understanding Pharmacology for Health Professionals 4th Edition Turley Test BankEmilyVaughanss
Full download : https://alibabadownload.com/product/understanding-pharmacology-for-health-professionals-4th-edition-turley-test-bank/ Understanding Pharmacology for Health Professionals 4th Edition Turley Test Bank , Understanding Pharmacology for Health Professionals,Turley,4th Edition,Test Bank
Number 13 of this series of 15 relates to nursing students learning how, when, what, dose, etc. to give medications. Patients trust you as you are the Patient's Advocate. This can seem overwhelming at first, but you will get to the point it is second nature. Most importantly, ASK if you are unsure of the dose, medication, contraindicators, allergies, etc. DO NOT allow yourself to be intimated by anyone. This is your patient and you must provide the absolute best nursing care.
Test bank calculating drug dosages a patient safe approach to nursing and mat...robinsonayot
Test bank calculating drug dosages a patient safe approach to nursing and math 2nd edition by castillo werner mccullough (1).pdf
Test bank calculating drug dosages a patient safe approach to nursing and math 2nd edition by castillo werner mccullough (1).pdf
An article on contamination of Diethylene Glycol in Pharmaceuticals. Thanks to Dr. Ajaz S. Hussain for all teaching, sharing knowledge and supporting in professional development.
Senior Project and Engineering Leader Jim Smith.pdfJim Smith
I am a Project and Engineering Leader with extensive experience as a Business Operations Leader, Technical Project Manager, Engineering Manager and Operations Experience for Domestic and International companies such as Electrolux, Carrier, and Deutz. I have developed new products using Stage Gate development/MS Project/JIRA, for the pro-duction of Medical Equipment, Large Commercial Refrigeration Systems, Appliances, HVAC, and Diesel engines.
My experience includes:
Managed customized engineered refrigeration system projects with high voltage power panels from quote to ship, coordinating actions between electrical engineering, mechanical design and application engineering, purchasing, production, test, quality assurance and field installation. Managed projects $25k to $1M per project; 4-8 per month. (Hussmann refrigeration)
Successfully developed the $15-20M yearly corporate capital strategy for manufacturing, with the Executive Team and key stakeholders. Created project scope and specifications, business case, ROI, managed project plans with key personnel for nine consumer product manufacturing and distribution sites; to support the company’s strategic sales plan.
Over 15 years of experience managing and developing cost improvement projects with key Stakeholders, site Manufacturing Engineers, Mechanical Engineers, Maintenance, and facility support personnel to optimize pro-duction operations, safety, EHS, and new product development. (BioLab, Deutz, Caire)
Experience working as a Technical Manager developing new products with chemical engineers and packaging engineers to enhance and reduce the cost of retail products. I have led the activities of multiple engineering groups with diverse backgrounds.
Great experience managing the product development of products which utilize complex electrical controls, high voltage power panels, product testing, and commissioning.
Created project scope, business case, ROI for multiple capital projects to support electrotechnical assembly and CPG goods. Identified project cost, risk, success criteria, and performed equipment qualifications. (Carrier, Electrolux, Biolab, Price, Hussmann)
Created detailed projects plans using MS Project, Gant charts in excel, and updated new product development in Jira for stakeholders and project team members including critical path.
Great knowledge of ISO9001, NFPA, OSHA regulations.
User level knowledge of MRP/SAP, MS Project, Powerpoint, Visio, Mastercontrol, JIRA, Power BI and Tableau.
I appreciate your consideration, and look forward to discussing this role with you, and how I can lead your company’s growth and profitability. I can be contacted via LinkedIn via phone or E Mail.
Jim Smith
678-993-7195
jimsmith30024@gmail.com
Specific ServPoints should be tailored for restaurants in all food service segments. Your ServPoints should be the centerpiece of brand delivery training (guest service) and align with your brand position and marketing initiatives, especially in high-labor-cost conditions.
408-784-7371
Foodservice Consulting + Design
Artificial intelligence (AI) offers new opportunities to radically reinvent the way we do business. This study explores how CEOs and top decision makers around the world are responding to the transformative potential of AI.
The case study discusses the potential of drone delivery and the challenges that need to be addressed before it becomes widespread.
Key takeaways:
Drone delivery is in its early stages: Amazon's trial in the UK demonstrates the potential for faster deliveries, but it's still limited by regulations and technology.
Regulations are a major hurdle: Safety concerns around drone collisions with airplanes and people have led to restrictions on flight height and location.
Other challenges exist: Who will use drone delivery the most? Is it cost-effective compared to traditional delivery trucks?
Discussion questions:
Managerial challenges: Integrating drones requires planning for new infrastructure, training staff, and navigating regulations. There are also marketing and recruitment considerations specific to this technology.
External forces vary by country: Regulations, consumer acceptance, and infrastructure all differ between countries.
Demographics matter: Younger generations might be more receptive to drone delivery, while older populations might have concerns.
Stakeholders for Amazon: Customers, regulators, aviation authorities, and competitors are all stakeholders. Regulators likely hold the greatest influence as they determine the feasibility of drone delivery.
The Team Member and Guest Experience - Lead and Take Care of your restaurant team. They are the people closest to and delivering Hospitality to your paying Guests!
Make the call, and we can assist you.
408-784-7371
Foodservice Consulting + Design
3. It reflects the views and understanding of presenter
& may not be construed to represent the views or
policies of organization or association to which
speaker has ties
Documents of US-FDA & Review Scientific
Articles are used to construct presentation
Disclaimer
Reference
6. An effective method of removing
defective product …
It is not limited to drugs but their
promotional literature too
Recall
7. If a drug is not of correct quality as authorized in
registration documents
It will be reported …
Severity of consequences will be assessed…
Recall will be initiated
Recall
18. Is classification of recall
necessary?
Yes
Response time
&
Methodology
will be different for
different classes
19. An effective method of removing
defective product …
It is not limited to drugs but their
promotional literature too
Recall
20. If a drug is not of correct quality as authorized in
registration documents
It will be reported …
Severity of consequences will be assessed…
Recall will be initiated
Recall
21. If extensive unexpected ADRs emerge &
establish …
It will be reported …
Severity of consequences will be assessed…
Withdrawal or label change will be initiated
Withdrawal
22. Any new information that
emerge & may influence the
judgment of benefit risk
concluded on previously
submitted applications
Reporting Obligations
23. The risk to patient health
The extent of the quality defects in terms
of batches & market distribution
Impact on market
Root cause of defect
Immediate or long term CAPA
Assessment of Defect
24. Product pose a
serious life
threatening risk
Class 1
Immediate
Medicines & Healthcare product Regulatory Agency
25. Product pose a
serious life
threatening risk
Defect could harm
the patient but not
life threatening
Class 1 Class 2
Immediate 48 hours
Medicines & Healthcare product Regulatory Agency
26. Product pose a
serious life
threatening risk
Defect could harm
the patient but not
life threatening
Defect is unlikely
to produce harm
Class 1 Class 3Class 2
Immediate 48 hours 5 days
Medicines & Healthcare product Regulatory Agency
27. Product pose a
serious life
threatening risk
Defect could harm
the patient but not
life threatening
Defect is unlikely
to produce harm
No threat to patient
safety
Class 1 Class 4Class 3Class 2
Immediate 48 hours 5 days
Alert
advice
Medicines & Healthcare product Regulatory Agency
28. Reasonable probability to see the
serious adverse health consequences
or death
Class I Response Time
US Food and Drug Administration
29. Reasonable probability to see the
serious adverse health consequences
or death
Class I Response Time
Temporary or medically reversible
adverse health consequences
or remote probability of
serious adverse health
Class II Response Time
US Food and Drug Administration
30. Reasonable probability to see the
serious adverse health consequences
or death
Class I Response Time
Temporary or medically reversible
adverse health consequences
or remote probability of
serious adverse health
Class II Response Time
Not likely to cause adverse
health consequencesClass III Response Time
US Food and Drug Administration
34. Label mix up on a life saving drug?
A drug that is under strength & not subject
for use to treat life threatening condition
A drug that has mistake in label in terms of
English or demographic data
A
B
C
35. A drug that is under strength & not subject
for use to treat life threatening conditionA I or II or III
36. A drug that is under strength & not subject
for use to treat life threatening conditionA I or II or III
37. Label mix up on a life saving drug?B I or II or III
38. Label mix up on a life saving drug?B I or II or III
39. A drug that has mistake in label in terms of
English or demographic dataC I or II or III
40. A drug that has mistake in label in terms of
English or demographic dataC I or II or III
41. Label mix up on a life saving drug?
A drug that is under strength & not subject
for use to treat life threatening condition
A drug that has mistake in label in terms of
English or demographic data
A
B
C
I or II or III
I or II or III
I or II or III