Culture of Quality - Part I (Updated & Reproduced) 03 Aug-2019

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Obaid Ali / Roohi B. Obaid

A training session conducted for pharmaceutical professionals of a particular organization

Leadership & Management

Creating a Sustainable Culture of Quality
Roohi B. Obaid
03 Aug 2019 (Part – I)

History & Prior Knowledge
Case Studies & Discussion on
Phenomena
Future & Emerging Map

Tutorial
Critical Thinking & connecting
the dots
Group Discussion

Use Reason
If you weigh and add correct
quantity of material
Do you think testing for
assay is required?

Use Reason
If you weigh and add correct
quantity of material
Do you think testing for
assay is required?
1
Tablet

Use Reason
If you weigh and add correct
quantity of material
Do you think testing for
assay is required?
2
IV Sol

Testing is an indicator of
quality insight

Group Discussion
Testing is sufficient
Testing is not sufficient
For
Quality

The drug which is tested, is not
given to patient
&
the drug which is given to patient
is not tested

Mistakes are not shared with bosses
Is it a Quality Culture?

Set the Tone of Quality Mode beyond the Compliance

Regulations
EnforcementCompliance
Guarantee
?

Aripiprazole
(1 mg/ml oral solution)
Potential small particles of API
may alter the efficacy
30 July 2019
MHRA
Oxycodone
(5 mg oral tablet)
Mix up of a strip of morphine
tablet 30 mg was reported
30 July 2019
TGA
Drospirenone
3 mg & Ethinyl
Estradiol 0.02 mg
OOS in dissolution
results at 3 mo
stability point
23 July 2019
FDA

Safe, efficacious & have correct identity
Assume …
…. Drugs are

Deliver the same performance as claimed
Assume …
…. Drugs will

Perform consistently over shelf life
Assume …
…. Drugs will

Made in a manner that ensure quality
Assume …
…. Drugs are

be available when needed
Assume …
…. Drugs will

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Creating a Sustainable Culture of Quality - Fundamental Module

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Your responses should be in a well-developed paragraph (300-350 words) to each peer. Integrating an evidence-based resource that is different than the one you used for the initial post. Respectfully agree and disagree with your peersâ€™ responses and explain your reasoning by Including your rationales in your explanation. The described expectations meet the passing level of 80%. Students are directed to review the Discussion Grading Rubric for criteria, which exceed expectations. APA format references , atleast 2 each. Response 1 What lifestyle modifications do you recommend for CF? It is crucial to educate and reassure CF. Perhaps if he understood how his choices affect the discomfort he is having, he would be more likely to adhere to the suggested treatment plan. Gastroesophageal reflux disease (GERD) can be prevented and cured by making straightforward lifestyle and dietary modifications (Cao et. al, 2019). First of all, I would recommend CF consider eliminating his nightly intake of wine as alcohol decreases lower esophageal sphincter (LES) tone; thus allowing for the contents of the stomach to flow back into the esophagus (Woo & Robinson, 2017). Additionally, eating smaller meals, and avoiding caffeine, chocolate, peppermint, and fatty foods can help prevent the acid reflux (Smith, 2018). Furthermore, I would inform CF that his choice to stop smoking was advantageous to his overall health. In relation to GERD, smoking inhibits the production of saliva causing a reduction of saliva in the mouth/throat; saliva helps to counteract the acidity of gastric secretions, thus avoiding smoking is best (Smith, 2018). Describe a rational drug choice for this patient. Be specific regarding what factors you would consider. Include pharmacokinetic and dynamic considerations for the pharmacological choices made. Also consider interactions and side effects. The entire class of proton pump inhibitors (PPI) are approved for treatment of GERD since they decrease gastric acid by over 90% (Woo & Robinson, 2017). Omeprazole (Prilosec) 20mg capsule by mouth once daily for a trial period of 4 weeks would be my rational drug choice for CF. Due to his age, negative physical exam, and the fact that he does not take daily medications, omeprazole would not interact with any current medications or put him at a concerning risk for osteoporosis. The benefits of omeprazole include rapid absorption of less than one hour and peak effect within 2 hours (Lexicomp, 2017). I would inform CF about common side effects such as dizziness, headaches, skin rash, constipation, diarrhea, flatulence, and nausea/vomiting (Lexicomp, 2017). What counseling points about this medication do you give CF? First of all, I would tell CF I wish to see him back in four weeks to discuss his potential experience with side effects, symptom relief including his being awakened at night with symptoms. Should he report his symptoms are controlled during the day and reappear before bed, .

Your responses should be in a well-developed paragraph (300-350 .docx

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Tutorial - 1: Creating & Sustaining a Culture of Quality

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1. Which choices below best reflect the problem statement for the instructor-assigned article? Not only does labor pain have negative effects on pregnant women and fetuses, women’s psychological and emotional states have a great effect on levels of perceived pain. There is a limited number of studies regarding labor dance. This study was conducted to determine the effects of labor dance on perceived labor pain, birth satisfaction, and neonatal outcomes. A labor dance that a pregnant woman performs with her partner reduces perceived pain and increases the woman’s satisfaction with birth. 2. Which of the choices below best reflects the purpose statement for the instructor assigned article? Not only does labor pain have negative effects on pregnant women and fetuses, women’s psychological and emotional states have a great effect on levels of perceived pain. There is a limited number of studies regarding labor dance. This study was conducted to determine the effects of labor dance on perceived labor pain, birth satisfaction, and neonatal outcomes. A labor dance that a pregnant woman performs with her partner reduces perceived pain and increases the woman’s satisfaction with birth. 3. According to Grove & Gray (2019), which of the following statements is important when considering the significance and relevance of a study's problem and purpose? Does it predict the non-significant findings anticipated in the study? Does it specifically influence nursing education in university settings? Does it identify the future research to be generated by the study? Does it promote theory testing or development? Does it identify extraneous variables? 4. When considering the feasibility of a study's problem and purpose, Grove & Gray (2019) suggest that several areas should be evaluated, including: researcher expertise, money commitment, ethical considerations, and availability of subjects, facilities, and equipment. Which of the following statements accurately assesses the feasibility of this article? (Select all that apply.) Funding sources for the study were clearly identified in the article. The author's credentials to design and conduct research are described. Evidence of protection of the subjects' rights was mentioned in this article. 100% of the eligible subjects contacted participated in the study. 5. According to Grove & Gray (2019), which one of the following is NOT a major purpose of the review of literature (ROL): Describing the current knowledge of the practice problem Identifying gaps in the knowledge base of the practice problem Explaining how the current study contributes to the knowledge being built To explain the reasons behind the selection of the statistics used in the study. 6. Select two MAJOR topics covered in the review of literature (ROL) from the list below: This experimental and prospective study aims to evaluate the effects of labor dance. Labor pain has major effects on both mother and fetus. Patients were excluded if they under ...

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ABSTRACT Overactive bladder (OAB) is a prevalent condition which has an adverse effect on quality of life. The presence of urgency incontinence confers significant morbidity above and beyond that of OAB sufferers who are continent. The primary treatment for OAB and urgency incontinence is a combination of behavioral measures and antimuscarinic drug therapy. The ideal antimuscarinic agent should effectively relieve the symptoms of OAB, with the minimum of side effects; it should be available as a once-daily sustained release formulation and in dosage strength that allows easy dose titration for the majority of sufferers. Solifenacin succinate was launched in 2005 and has been shown in both short and long term clinical trials to fulfill these requirements. Solifenacin is a competitive M3 receptor antagonist with a long half-life (45-68 hours). It is available in two dosage strengths namely a 5 or 10 mg once-daily tablet. The efficacy and tolerability of solifenacin for the treatment of all symptoms of OAB has been evaluated in a number of large, placebo controlled, randomized trials. Long-term safety, efficacy, tolerability and persistence with treatment have been established in an open label 40 week continuation study. KEYWORDS Solifenacin, Urinary incontinence, Overactive bladder and Wet granulation method.

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Culture of Quality - Part I (Updated & Reproduced) 03 Aug-2019

1. Creating a Sustainable Culture of Quality Roohi B. Obaid 03 Aug 2019 (Part – I)

3. (10 Min) Pre - Assessment

4. History & Prior Knowledge Case Studies & Discussion on Phenomena Future & Emerging Map

5. Tutorial Critical Thinking & connecting the dots Group Discussion

6. Use Reason If you weigh and add correct quantity of material Do you think testing for assay is required?

7. Use Reason If you weigh and add correct quantity of material Do you think testing for assay is required? 1 Tablet

9. Use Reason If you weigh and add correct quantity of material Do you think testing for assay is required? 2 IV Sol

10. Dextrose solution

11. Testing is an indicator of quality insight

12. Group Discussion Testing is sufficient Testing is not sufficient For Quality

13. The drug which is tested, is not given to patient & the drug which is given to patient is not tested

14. Mistakes are not shared with bosses Is it a Quality Culture?

15. Set the Tone of Quality Mode beyond the Compliance

16. Regulations EnforcementCompliance Guarantee ?

17. Recalls

18. Aripiprazole (1 mg/ml oral solution) Potential small particles of API may alter the efficacy 30 July 2019 MHRA Oxycodone (5 mg oral tablet) Mix up of a strip of morphine tablet 30 mg was reported 30 July 2019 TGA Drospirenone 3 mg & Ethinyl Estradiol 0.02 mg OOS in dissolution results at 3 mo stability point 23 July 2019 FDA

19.

20.

21. Safe, efficacious & have correct identity Assume … …. Drugs are

22. Deliver the same performance as claimed Assume … …. Drugs will

23. Perform consistently over shelf life Assume … …. Drugs will

24. Made in a manner that ensure quality Assume … …. Drugs are

25. be available when needed Assume … …. Drugs will

26. Thanks

Culture of Quality - Part I (Updated & Reproduced) 03 Aug-2019

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