ICH Q7 & Q11

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Obaid Ali / Roohi B. Obaid

Presented at length on 23 April and 21 May 2017 at ICCBS, HEJ and Getz Pharma Auditorium, Karachi in a Discussion Forum of about 800 practicing university qualified professionals of various pharmaceutical manufacturing industries

Discussion Forum on ICH Q7 & Q11
Interactive Opening Discussion
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
23 April 2017 (Program A)
21 May 2017 (Program B)

Interactive Opening Discussion
Q7 Q11

Ingredients Process Product

Can a drug product manufactured from a
non-compliant API ensure safety???

SM IM API Excipients
Capsule
shell
Is GMP required? Yes / No

ICH Q7 & Q11

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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

W.H.Bender Quote 66 - ServPoints Sequence of Service™ should be Identified fo...

W.H.Bender Quote 66 - ServPoints Sequence of Service™ should be Identified fo...

W.H.Bender Quote 66 - ServPoints Sequence of Service™ should be Identified fo...

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Comparing Stability and Sustainability in Agile Systems

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20240608 QFM019 Engineering Leadership Reading List May 2024

20240608 QFM019 Engineering Leadership Reading List May 2024

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原版制作(澳洲WSU毕业证书)西悉尼大学毕业证文凭证书一模一样

原版制作(澳洲WSU毕业证书)西悉尼大学毕业证文凭证书一模一样

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