This presentation discusses the importance of understanding pharmaceutical products and processes in order to prevent quality issues and recalls. It provides several examples of recent drug recalls that occurred due to a lack of control or understanding of the product and manufacturing process. These issues include super or sub potent formulations, particulate contamination, active pharmaceutical ingredient contamination, sterility failures, and dissolution or disintegration failures. The presentation emphasizes that companies must validate their manufacturing processes, maintain strict controls, monitor all aspects of production, and be prepared to modify their strategies as needed to ensure safe, effective drugs are consistently produced.
Take a Breath, Look Back, See Around, Predict Future & Have a Dream to make D...Obaid Ali / Roohi B. Obaid
More than 400 participants represented dozens of manufacturing companies with diversified educational background & experience attended throughout the day with active participation in discussion forum of Regulatory & Quality Sciences.
Take a Breath, Look Back, See Around, Predict Future & Have a Dream to make D...Obaid Ali / Roohi B. Obaid
More than 400 participants represented dozens of manufacturing companies with diversified educational background & experience attended throughout the day with active participation in discussion forum of Regulatory & Quality Sciences.
Presented to a small group of working professionals (Constructed from different documents of FDA, ISPE etc. available on public domain) - Personal point of view
More than 400 participants represented dozens of manufacturing companies with diversified educational background & experience attended throughout the day with active participation in discussion forum of Regulatory & Quality Sciences.
Lifezen Healthcare Pvt. Ltd. is a healthcare brand that aims to develop innovative healthcare offerings that provide the ultimate care of life and well-being. We specialize in over - the - counter (OTC) products in different therapeutic segments, and we aim to become a comprehensive OTC healthcare organization.
The Top 5 Trusted Nutri Ingredient Suppliers & Manufacturers of 2023.pdfinsightscare
In this edition of Insights Care, The Top 5 Trusted Nutri Ingredient Suppliers & Manufacturers of 2023, you will discover Nutri Ingredient Suppliers & Manufacturers
Dr. Paul Ruen - Hanson Lecture: Changes in Antimicrobial Use - PractitionerJohn Blue
Hanson Lecture: Changes in Antimicrobial Use - Practitioner - Dr. Paul Ruen, Fairmont Veterinary Clinic, LLP, from the 2016 Allen D. Leman Swine Conference, September 17-20, 2016, St. Paul, Minnesota, USA.
More presentations at http://www.swinecast.com/2016-leman-swine-conference-material
This was the presentation given at the Trottier Symposium in Montreal, Canada, September 27, 2015. The session was "A Question of Evidence" and discussed major scientific topics of public controversy.
NECC produced tainted drug that killed over 40 people and sickened over 700. This presentation explores the quality and microbiology failures that lead to this catastrophe.
Presented to a small group of working professionals (Constructed from different documents of FDA, ISPE etc. available on public domain) - Personal point of view
More than 400 participants represented dozens of manufacturing companies with diversified educational background & experience attended throughout the day with active participation in discussion forum of Regulatory & Quality Sciences.
Lifezen Healthcare Pvt. Ltd. is a healthcare brand that aims to develop innovative healthcare offerings that provide the ultimate care of life and well-being. We specialize in over - the - counter (OTC) products in different therapeutic segments, and we aim to become a comprehensive OTC healthcare organization.
The Top 5 Trusted Nutri Ingredient Suppliers & Manufacturers of 2023.pdfinsightscare
In this edition of Insights Care, The Top 5 Trusted Nutri Ingredient Suppliers & Manufacturers of 2023, you will discover Nutri Ingredient Suppliers & Manufacturers
Dr. Paul Ruen - Hanson Lecture: Changes in Antimicrobial Use - PractitionerJohn Blue
Hanson Lecture: Changes in Antimicrobial Use - Practitioner - Dr. Paul Ruen, Fairmont Veterinary Clinic, LLP, from the 2016 Allen D. Leman Swine Conference, September 17-20, 2016, St. Paul, Minnesota, USA.
More presentations at http://www.swinecast.com/2016-leman-swine-conference-material
This was the presentation given at the Trottier Symposium in Montreal, Canada, September 27, 2015. The session was "A Question of Evidence" and discussed major scientific topics of public controversy.
NECC produced tainted drug that killed over 40 people and sickened over 700. This presentation explores the quality and microbiology failures that lead to this catastrophe.
Similar to Understanding of Product & Process for Installation of Appropriate Controls (12 April 2017) (20)
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
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
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.
Oprah Winfrey: A Leader in Media, Philanthropy, and Empowerment | CIO Women M...CIOWomenMagazine
This person is none other than Oprah Winfrey, a highly influential figure whose impact extends beyond television. This article will delve into the remarkable life and lasting legacy of Oprah. Her story serves as a reminder of the importance of perseverance, compassion, and firm determination.
Oprah Winfrey: A Leader in Media, Philanthropy, and Empowerment | CIO Women M...
Understanding of Product & Process for Installation of Appropriate Controls (12 April 2017)
1. Understanding of Product & Process
For Installation of Appropriate Controls
Roohi B. Obaid, R. Ph.
Civil Services Officer
Member ISPE & PDA
12 April 2017
2. D
I
S
C
L
A
I
M
E
R
Not the view
of DRAP
Current
judgment
No
obligation
on DRAP
Regulatory
experience
This presentation discusses science and has nothing to do with
any commercial Product.
9. Does anybody want to see such news early morning?
Are you confident it will not happen with you?
10. Does anybody want to see such news early morning?
Are you confident it will not happen with you?
Don’t assume but
keep respecting
science
11. Does anybody want to see such news early morning?
Are you confident it will not happen with you?
Don’t assume but
keep respecting
science
Understand your
product &
process
12. Does anybody want to see such news early morning?
Are you confident it will not happen with you?
Don’t assume but
keep respecting
science
Understand your
product &
process
Before it
happens
26. 1
Super or sub potent formulations
Digoxin (double
thickness)
Actavis 2008
27. 1
Super or sub potent formulations
Digoxin (double
thickness)
Actavis 2008
Poor Manufacturing Control
28. 1
Super or sub potent formulations
Morphine (double size)
KV Pharmaceuticals 2008
Company closed because
they knew the problem &
failed to inform FDA
Fine of 27.6 million USD
29. 1
Super or sub potent formulations
Morphine (double size)
KV Pharmaceuticals 2008
Company closed because
they knew the problem &
failed to inform FDA
Fine of 27.6 million USD
Poor Manufacturing Control
30. 2
Particulate Contamination
Takeda, Millenium &
Janssen anti-cancer product
Particulates were seen after
reconstitution
Europe, America & Asia
Polyester like material
originated from filtration
system
31. 2
Particulate Contamination
Takeda, Millenium &
Janssen anti-cancer product
Particulates were seen after
reconstitution
Europe, America & Asia
Polyester like material
originated from filtration
system
Wrong sort of container used
to store highly acidic or
basic solution
32. 2
Particulate Contamination
Takeda, Millenium &
Janssen anti-cancer product
Particulates were seen after
reconstitution
Europe, America & Asia
Polyester like material
originated from filtration
system
Glass, silicon & stainless steel …. …in the
glass used to manufacture vials and other
containers.
wear and tear of machinery, abrasion of
stoppers and plungers …in the glass used to
manufacture vials and other containers.
33. 2
Particulate Contamination
Takeda, Millenium &
Janssen anti-cancer product
Particulates were seen after
reconstitution
Europe, America & Asia
Polyester like material
originated from filtration
system
Inadequate understanding of
the product and process
34. 3
API’s Contamination
Bulk heparin in China
Over sulfated Chondroitin
Sulfate
80 deaths in USA alone
Found deliberated &
economically motivated
35. 3
API’s Contamination
Bulk heparin in China
Over sulfated Chondroitin
Sulfate
80 deaths in USA alone
Found deliberated &
economically motivated
Weak supply chain
Unknown contaminant later
named OSCS
37. 3
API’s Contamination
GSK Worthing UK facility
July 2015
Bactobran cream
containing Mupirocin
recalled
API Mupirocin
contaminated with penicillin &
foreign substances during Mfg
process
38. 3
API’s Contamination
GSK Worthing UK facility
July 2015
Bactobran cream
containing Mupirocin
recalled
Inadequate Controls to
Prevent contamination
40. 3
API’s Contamination
Attix Pharmaceuticals
Canada (April 2015)
A Repackager recalled
hundreds of bulk API
cross-contaminated by
penicillin
Failed to use separate
facilities or equipments
Inappropriate practice during operations
Personnel & material movement, use of
non-dedicated facilities
41. 3
API’s Contamination
Attix Pharmaceuticals
Canada (April 2015)
A Repackager recalled
hundreds of bulk API
cross-contaminated by
penicillin
Failed to use separate
facilities or equipments
Cleaning is not
a substitute for
segregation
42. 3
API’s Contamination
Attix Pharmaceuticals
Canada (April 2015)
A Repackager recalled
hundreds of bulk API
cross-contaminated by
penicillin
Failed to use separate
facilities or equipments
Cleaning is not
a substitute for
segregation
No safe level of
penicillin
contamination has
been determined to
be a tolerable risk
45. 3
Contamination
Misoprostol Pharmacia
Peak gave signal but
ignored (13 lots)
Later contaminant
identified to be toluene
Loose ink in blister packaging line
Diethylphthalate (DEP) … from
desiccant cartridge
46. 3
Contamination
Misoprostol Pharmacia
Peak gave signal but
ignored (13 lots)
Later contaminant
identified to be toluene
Loose ink in blister packaging line
Diethylphthalate (DEP) … from
desiccant cartridge
Cause could not be assigned
whether a residue from API or
improper packaging ….
47. 4
Sterility Failure
Various drugs for potential
sterility failure found
contaminated with
pathogenic organisms
High threat for HIV, Cystic
Fibrosis or TB
48. 4
Sterility Failure
Various drugs for potential
sterility failure found
contaminated with
pathogenic organisms
High threat for HIV, Cystic
Fibrosis or TB
Poor manufacturing & environmental
control
49. 5
Contamination with TBA
Bad odour in product
J&J 2009
Pfizer 2010
TBP, a wood preservative
for pallets converted to
TBA giving bad odour
50. 5
Contamination with TBA
Bad odour in product
J&J 2009
Pfizer 2010
TBP, a wood preservative
for pallets converted to
TBA giving bad odour
Poor control and desensitized alarms,
throwing away of wake up calls, ended
up with largest recall
61. 1999 to 2005
Enormous growth & expansion
17 - 55% per share
2005 - Major recall due to falsification of data
Flouting, altering or manipulation & reporting
62. 1999 to 2005
Enormous growth & expansion
17 - 55% per share
2005 - Major recall due to falsification of data
Flouting, altering or manipulation & reporting
2007 - Charged
All drugs withdrawn, company shut down
63.
64. Lets hear and watch the way Leaders
come forward to protect trust
These are the norms of moral business