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- Woe Is Me – Compliance Needs to Be Job 1 in India--Read Now!
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- Zika Virus Vaccine
Posts
Announcements
- 5 Important Factors to Measure in Your Lean Process Strategy
- Advances in Pediatric Personalized Medicine Are Highlighted at Unique International Conference
- Careers at Smart Pharmaceutical Consulting
- Could a Shot of Tequila Be What People Suffering from Bone Loss Need?
- Diabetes Trends Until 2025
- FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake
- FTC Releases Report on “Follow-on Biologic Drug Competition”
- Glaxo and Pfizer Will Provide Pneumonia Vaccines
- GMP Guidelines/Regulations in Stem Cell Research
- Guilty as Charged: The Premature Stop of Clinical Trials Exaggerates the Effects of Treatment
- How to Get Through a Successful Pre-Approval Inspection
- How to Perform a Mock Audit
- How Will Obama Care Affect the Pharmaceutical Industry?
- Innovative R&D Through Lean Manufacturing Principles
- Key Factors in Third Party Testing on Combination Products
- Life Science Leaders Discuss Strategies for Surviving the Financial Crisis at Yankee Public Relations Symposium
- Management Responsibilities and Automation Techniques in Regulated Pharma Environments as Per a Suggested Quality System Model
- New Data on the Inspection of Human Cell & Tissue Products by the FDA
- Pharma Sales Reps Facing a Hostile World
- Save The Date: Unexpected Leader Book Signing 21st May 2024
- Smart Pharmaceutical Consulting LLC Awarded a GSA contract on the MOBIS schedule
- The Battle Brewing Over Vaccinations
- The FDA Inspection Process; Tips and strategy
- The Future of Regenerative Medicine
- The Role of Interim Monitors in Divestitures
- The Secret to Tissue Regeneration… In The Body of a Worm?
- The Secret to Tissue Regeneration… In The Body of a Worm?
- Tips to Improve your Laboratory Performance
Articles
- 10 Tips for Effective Process Mapping
- 483 Audit Forms
- 5 Steps To Make Your Pharmaceutical Product A Success
- 5 Things To Avoid When Launching A Health Care Product
- A great link to CDERLearn
- A New Approach to Quality Systems Management
- AAI, CONSUMER GROUPS ENCOURAGE CONGRESS TO BAN PATENT SETTLEMENTS AND RESTORE COMPETITION IN MARKET FOR GENERIC DRUGS
- About Us for Consulting Business
- Adding Value
- Adult Stem Cells Show Potential for the Treatment of Cardiac Patients
- Advancements in Mobile Technology Resolve Problems for Pharmaceutical Industry
- Advances in Chikungunya Virus DNA Vaccine
- Advantages of Interim Pharmaceutical Consulting
- And the H1N1 Vaccine’s Surprises Keep Rolling
- Assuring Quality at CDMO’s during Covid-19 Using a Remote Strategy
- Avoiding the Pitfalls of Pharmaceutical Consulting
- BARDA and their Countermeasures Initiative
- Be Prepared When the FDA Knocks on Your Door
- Behind The Increasing Need for Pharmaceutical Consultants
- Benefits of Environmental Monitoring
- Best Practices of Smart Consultants
- Big Pharma Joins Twitter as a Marketing and Customer Service Tool
- Big Pharma Looking For M&A To Fill Their Drug Pipeline
- Biopharma 4.0; Bioprocessing and where is it going?
- Biosimilars at Full Speed
- Blockchain and Pharmaceutical Supply Chain Verification
- Blue Sky Approaches to Drug Development Opens the Door to Breakthrough Therapies
- Bottlenecking Theory
- Boy Receives New Trachea Thanks to Stem Cells
- Brainstorming Strategies for Teams
- Building a Successful Lean Strategy for your Medical Products Company
- Building an Optimal Quality System
- Building Value in a Biotech Company Through Partnerships
- Business Process Management, Digitization and Lean/Process Excellence: Some thoughts on the roles for future success
- CDER’s Small Business Assistance Bulletin
- Change Management Within Pharmaceutical Companies
- Change Management, Culture Change and Where / How to Start
- Change Management; A Vital Part of the Lean Mechanism within the Life Sciences Industry.
- Choosing a CMO to be your partner in your production supply chain
- Clinical Trial Management
- Companies, People, Strategies. How to Align all Three to Assure success?
- Comparative Effectiveness and Health Care Reform
- Comparing the House and Senate Healthcare Bills
- Compliance Tips For cGMP Inspections
- Congress Oversight Of Pharmaceutical Industry
- Considerations In The Manufacture Of Recombinant Drugs
- Consolidation Activity in the Generic Sector
- Cost and Benefit in the Pharmaceutical Industry
- Counteracting Expanding FDA Reporting Requirements Through Lean Manufacturing
- Counterfeiting: The FDA Seeks Guidance on New PCIDs
- Creation of a Winning Business Plan
- Critical factors in Filing NDC numbers with the FDA
- Data Integrity and the negative impact on Products Manufacturing
- Dealing With FDA Pre-Aprroval Inspections
- Delivering Success in an FDA Inspection Process – Part 1
- Delivering Success in an FDA Inspection Process – Part 2
- Delivering Success in an FDA Inspection Process – Part 3
- Delivering Success in an FDA Inspection Process – Part 4
- Developing Quality Pharmaceutical Systems
- Development validation Programs for Biopharmaceutical Companies
- Diabetes Trends Until 2025
- Dietary Supplements, cGMP Manufacturing & Regulatory Compliance
- Dishonest Marketing in Pharmaceuticals Demands a Big Price to Pay
- Disposable Components In Bioprocessing Production Lines
- Disposables and Single –Use Systems: A Way to Drive Biomanufacturing from a Lean Perspective
- Do Start up Life Science Companies need Quality Management Systems?
- Don’t keep failing, implement a LEAN Laboratory approach!
- DTC Genetic Tests…The Good, the Bad and the Future
- Effective Supplier Auditing for Quality Management
- Eliminating Pharmaceutical Manufacturing Chaos through Implementation of an Effective 5S Program
- Embracing Technology Transfer
- Emerging Markets In the Pharmaceutical Industry
- Emerging Trends in the Pharmaceutical Industry
- Employing Lean together with the “Internet of Things” produce the “Brilliant Factory.”
- Ensuring QC for Laboratory Operations
- Experimental Obesity Drug Could Treat Diabetes
- Failing an FDA Inspection
- Fall Networking Event, a Success!
- FDA Readiness. Strategies and Tips for Success
- FDA Regulations
- FDA Resolves Compliance Issues with Drug/Device Combination Products
- FDA’s Response to a Developing Pandemic
- Federal Funding For Biomedical Research
- Fishbone Analysis
- Flow Charting
- Four Steps to Successful Team Building
- FTC Commissioner Rosch Will Speak at ACI’s Pharmaceutical Antitrust Forum
- Future of BioPharma
- Generating efficiency through efficient Laboratory Integration
- Genetic Testing For The Masses
- Glaxo and Pfizer Will Provide Pneumonia Vaccines
- GMP Guidelines/Regulations in Stem Cell Research
- Great Ways to Reduce Stress at Your Job
- Growing Cooperation between Big Pharma and Patients
- Guilty as Charged: The Premature Stop of Clinical Trials Exaggerates the Effects of Treatment
- Having The Edge In The Production of High Quality Pharmaceuticals
- Hiring a Pharmaceutical Consultant: 7 Steps to Success
- How a Pharmaceutical Consultant Can Improve Business Health
- How Bioscience Companies are Using Social Media to Reach Key Audiences
- How Do Pharmaceutical Companies Develop Value in These Current Times?
- How Life Science Companies can Survive the Economic Downturn
- How to Be a Pharmaceutical Sales Consultant
- How to be Successful with your Supplier Audits in a COVID-19 world
- How to Create Real Competitiveness through Effective Integration with QA/QC
- How to Develop New Employee Orientation Programs for GXP Compliance
- How to Do a SWOT Analysis as Part of a Business Plan or Business Process Strategy
- How To Get Ready For a Merger Or Acquisition
- How To Implement Lean In The Lab
- How to Leverage Lean Principles to Improve Quality Compliance
- How to Prepare for the New Structure for Approval of Follow-on Biologics
- How to Prepare Your Company for an FDA Inspection
- How to Prepare Your Company for FDA Audits
- How to start with a program to improve your QC laboratory performance
- How to successfully navigate the FDA site inspection process
- How Will Obama Care Affect the Pharmaceutical Industry?
- Human Error Reduction
- Ideas to Generate Lean Compliant Standard Operating Procedures
- Implementation of an Integrated Lean Laboratory Strategy
- Important Information about Lab Ergonomics
- Importation Law and Mandatory FDA Inspections
- Incorporation of Lean Techniques to drive efficiency in processing deviations
- India, Strong Pharma Destination
- Influenza of the Future
- Inspection Readiness and Follow Through in a Covid-19 era
- International Pharmaceutical Companies Make Global Impact on H1N1 Vaccine
- International Pharmaceutical Conference & Expo
- Is a Standardized Approach to Improving CAPA Performance Required?
- Is the Pharmaceutical Industry Going Green?
- Issues Connected with Device Combination Product Convenience Kits
- Issues for Device Combination Products
- Kaizen Events
- Key Elements of a Business Plan for a Pharmaceutical Business
- Key Factors in Third Party Testing on Combination Products
- Key Note Talk IPharma 2018
- Key Points to consider in performing a Suppler cGMP Audit. The Perils of not paying attention!
- Key Points to consider in performing a Suppler cGMP Audit. The Perils of not paying attention!
- Key Points to look at in performing a Supplier cGMP Audit. The Perils of not paying attention.
- Leachables and Extractables in Biopharmaceutical Processing
- Lean Alone Is Not Enough
- Lean Analysis and Optimization for Pharmaceutical and Biopharmaceutical Manufacturing
- Lean Approaches in Bioprocessing to Help Minimize Variability in Production Yields
- Lean Biomanufacturing: Keeping Your Eye on the Quality Goal
- Lean efficient production of modern therapeutic agents
- Lean Enterprising; A term coming of age in the Implementation of Lean in the Life Science Industry
- Lean Laboratory Saves Time and Money for Pharmaceutical Industry
- Lean Manufacturing and PAT – The Next Level For Pharma
- Lean Manufacturing and Waste Elimination
- Lean Manufacturing for the Competitive Edge
- Lean Manufacturing Implementation: Successfully Overcoming Obstacles
- Lean Manufacturing Solves Drug Recalls and Bad Press
- Lean Manufacturing: What it means to the Pharmaceutical Industry
- Lean Operational Compliance in the New Pharmaceutical Industry Environment
- Lean Philosophy and the Life Science Industry
- Lean Product Change–Over in an FDA Regulated Environment
- Lean Six Sigma and Process Excellence to the Rescue
- Leveraging Lean, The Internet of Things and Enhanced Business Processes to Improve Pharmaceutical Manufacturing
- LIMS for Lab Quality Control
- Looking for Money in New Places
- Making Relationships Count With Life Sciences Consulting
- Management Responsibilities and Automation Techniques in Regulated Pharma Environments as Per a Suggested Quality System Model
- Managing Data and Documentation for FDA GMP Inspections.
- Manhattan Research Study Shows That Three Out of Four Nurses Recommend Health Websites to Their Patients
- Manufacturing Supply from Asia. At what point does this put the US Healthcare consumer at risk?
- Metrics and their Importance in Lean Biomanufacturing
- Microbiology: Transcending Waste With Lean Manufacturing
- More on the Topic of FDA Inspections
- NDC codes: National Drug Codes and How They are Assigned
- New and Amazing Discoveries on the Development of Cells
- New Chancellor At University Of California
- New Leadership Principles for Manufacturing in GMP Facilities
- New Services offered for sourcing Pharmaceuticals
- New Stem Cell Technology Better Helping Bone Fracture Patients
- Nigel Smart Speaks About The Production of High-Quality Pharmaceuticals at CPhI China In Shanghai
- Nigel today at the American Outsourcing Event, Crown Plaza Hotel, Cherry Hill NJ
- Novel Stem Cell Technology for Bone Fractures Developed
- Opportunities to Save Big Bucks in the Pharmaceutical Industry
- Outcomes from 483 Observations
- Outsourcing Biopharmaceutical Manufacturing
- Particle Size And Variability In Pharmaceutical Manufacturing
- Patent Holders, Watch Out!
- Patient Safety Resides in Global Thinking
- Pharma 4.0 and what it really means for the Production of High-Quality Pharmaceutical Products
- Pharma CEOs Confident About Growth And Opportunity In Next 12 Months
- Pharma Sales Reps Facing a Hostile World
- Pharmaceutical Companies Rush Ahead to Prepare Swine Flu Vaccine
- Pharmaceutical Consultants Broaden the Scope
- Pharmaceutical Consultants-The Key to a Rapidly Changing Industry
- Pharmaceutical Consulting and BMI’s 4th Quarter Update
- Pharmaceutical Consulting Firms: Hero or Hype?
- Pharmaceutical Industry Contributes to Future of Personalized Medicine
- Pharmaceutical Marketing Strategies towards Physicians Are Not Trusted
- Poka-Yoke as a Mechanism to Assure Reliable Production of Pharmaceuticals and Other Life Science Products.
- Post FDA Inspection Activities
- Preparing For Your Mock PAI Audit
- Preparing Your Company For an REM Evaluation
- Process Validation: Thoughts on a New Guidance for an Old Issue
- Production of Covid-19 Vaccine Candidates. A Flexible Strategic Approach.
- Progress Of Single-Use Systems In Bioprocessing
- Proposed FDA cGMP Regulations Impact Pharmaceutical and Biotech Industries
- Protect Yourself from the H1N1 Vaccine
- Qualified Lean Manufacturing Consultants: Make or Break
- Quality Standards, India?
- Reaching into Research and Development of a Supply Chain Strategy
- Regenarative Medicine Advancements In Research Attract Financing
- Regulated Production Of CBD. What Manufactures Should Know?
- Regulatory Inspection Readiness
- Remediating Your Pharmaceutical Company To Lift You Out Of A Serious Compliance Problem
- REMS Risk Management Strategies
- Retirement of Mickey Flynn
- Risk analysis and Quality Systems in Development of LEAN Compliance Systems in Pharmaceutical Development and Manufacturing
- Risk Management as a Strategic Survival Tool for Bioscience Companies
- Risk Management as part of your Lean Compliance Strategy to enable you to meet your Compliance Obligations.
- Risks in Lean Compliance
- Roles, Goals and Rules of Successful Team Building
- Scenarios For Health Care Reform
- SCG’s thoughts on the last 10%
- Selection Of Expression Systems In Recombinant Protein Production
- Shortened Lead Times as a Key Component of Lean Biomanufacturing
- Should we be using iPhone video procedures?
- Simple Secrets to Generate Better Optimised Processes Resulting in Fewer Errors & Inefficiencies.
- Single-Use Reactor Technology Costs
- Smart Manufacturing: What’s Involved In The Next Wave for Competitiveness
- Smart Pharmaceutical Consulting Doubles-Down
- Smart Pharmaceutical Consulting Partners with Yuan Woo International
- Smart Pharmaceutical Consulting Teams up with John Assaraf and One Coach to Develop Enhanced Consulting Services for the Bioscience Industry
- Smooth Business Process Management and its importance in Deviation management
- Stages in the Production of Pharmaceutical Products
- Strategies for Efficient Energy Use in Pharmaceutical Manufacturing Plants
- Strategy for FDA Inspection Process; Part 5
- Striving For A Change
- Success Strategies for an FDA Inspection; Useful tips
- Supplier Audits and Maintaining Quality Compliance
- Supplier Client Relationship Issues; Making it work
- Supreme Court Rules that Design-Defect Vaccine Injury Claims are Pre-empted
- Surviving FDA Inspectors
- Sustainable Pharmaceutical Manufacturing
- The 6 Crucial Principles in Pharmaceutical Leadership
- The Benefits of Pharmaceutical Process Development
- The Benefits of Using Pharmaceutical Consultants
- The Best Medicine For The Pharmaceutical Business
- The Challenges Emerging for Combination Products
- The Continuing Journey of Lean Manufacturing in the Pharmaceutical Industry
- The Drive Behind Lean Manufacturing Implementation
- The Exciting and Future Role Of Stem Cells in the Health Industry
- The Future Lies in Two Words – Emerging Markets
- The Future of Engineering in Pharmaceuticals
- The Future of Influenza Vaccine Design
- The Future of Products Regulated by Good Tissues Practices. The Transition from GTP to GMP
- The Future of Regenerative Medicine
- The Future of Regenerative Medicine
- The Global Vaccines Market, 2008-2023
- The Importance of a Competitive Analysis
- The importance of appropriate Training in the Life Science Regulated industry
- The Importance of Good GMP Documentation & Data Entry
- The Importance of Key Performance Indicators
- The importance of KPI’s in the improvement of Pharmaceutical Quality Compliance
- The Lean Laboratory of the 21st Century
- The Lean Side of Pharmaceuticals
- The Marriage between Big Pharma and Mobile Technology
- The New Ways for the Pharma Industry
- The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes
- The Pharmaceutical Industry Gets Six Sigma and Lean Manufacturing
- The Pharmaceutical Industry is Under Pressure
- The Right Sequence for Lean Manufacturing Implementation
- The Role of Interim Monitors in Divestitures
- The Secret to Tissue Regeneration… In The Body of a Worm?
- The Secret to Tissue Regeneration… In The Body of a Worm?
- The Smart Road to Pharmaceutical Consulting
- The Tremendous Value of a Virtual Organization
- The Use of Artificial Intelligence in Improving the Quality and Efficiency of Pharmaceutical Processes
- The Use of Process Mapping, Value Stream Mapping and Score Cards in developing a Lean Culture in Life Sciences Companies.
- The Value of Critical Thinking
- Tips For Effective Process Mapping
- Tips to ensure a better experience associated with Close out Meetings after an FDA Inspection
- Tips to Improve your Laboratory Performance
- Transforming the Traditional Approach with Lean Manufacturing Techniques
- U.S. Falls Behind Europe in Research and Drug Development
- Universal Health Coverage Dilemma
- Universal Healthcare And Drug Company Revenues
- Value Stream Mapping
- Venturing into the Bold World of Combination Products
- Visual Factory Methodology to improve Lean Manufacturing in Life Science Product Companies
- Waste Removal
- What a Life Sciences Consulting Firm Can Offer Your Business
- What have you learned about dealing with change in your industry?
- What If You Fail The FDA Pre Approval Inspection?
- What is Environmental Monitoring and Why it is So Critical
- What is Lean Manufacturing and Its Benefits?
- What is Pharmaceutical Outsourcing?
- What is the right CMO for your product? Selecting a good partner.
- What the New Health Care Overhaul Means To You
- What to Look for in Life Sciences Consulting Groups
- What You Need to Know About Vendor Audits
- What You Should Know About Your cGMP Inspection
- What’s involved with 483 Observations
- What’s Wrong With Conventional Laboratories?
- WHO Ebola Vaccine Meeting
- Why a Lean Laboratory Approach Can Yield Dividends?
- Why Have a Mission Statement?
- Why Not Approve Medications Sold Online?
- Why Should Pharmaceutical Companies Develop Comprehensive Regulatory Training Programs?
- Why the Pharmaceutical Industry Needs to Adapt to Emerging Markets
- Why You Should Be Using Meditation in the Workplace
- Will the Hard Times For Bio-Tech Companies Continue?
- Woe is Me-Compliance Needs to be Job 1 in India–Read Now!
Career Opportunities
Case Studies
- Case Study: Divestiture of a Prescription Generic Pharmaceutical Pursuant to an Federal Trade Commission Consent Order
- Case study: Lean efficiency analysis of QC function for a major pharmaceutical manufacturer
- Case Study: Lean Laboratory Process for Medical Device Company
- What the New Health Care Overhaul Means To You
- What You Need to Know About Vendor Audits
Testimonials
White Papers
- Avoiding the Pitfalls of Pharmaceutical Consulting
- BARDA and their Countermeasures Initiative
- Compliance Tips For cGMP Inspections
- Counteracting Expanding FDA Reporting Requirements Through Lean Manufacturing
- GMP Guidelines/Regulations in Stem Cell Research
- Hiring a Pharmaceutical Consultant: 7 Steps to Success
- How a Pharmaceutical Consultant Can Improve Business Health
- Innovative R&D Through Lean Manufacturing Principles
- Issues for Device Combination Products
- Lean Manufacturing and PAT – The Next Level For Pharma
- Lean Manufacturing and Waste Elimination
- Lean Manufacturing for the Competitive Edge
- Lean Manufacturing Implementation: Successfully Overcoming Obstacles
- Lean Manufacturing Solves Drug Recalls and Bad Press
- Lean Manufacturing: What it means to the Pharmaceutical Industry
- Making Relationships Count With Life Sciences Consulting
- MAKING THE CASE: The Imperative for Life Sciences Companies to Integrate Corporate Compliance and Quality Compliance
- Microbiology: Transcending Waste With Lean Manufacturing
- Pharmaceutical Consultants Broaden the Scope
- Pharmaceutical Consultants-The Key to a Rapidly Changing Industry
- Pharmaceutical Consulting and BMI’s 4th Quarter Update
- Pharmaceutical Consulting Firms: Hero or Hype?
- Qualified Lean Manufacturing Consultants: Make or Break
- Reaching into Research and Development of a Supply Chain Strategy
- The Benefits of Using Pharmaceutical Consultants
- The Continuing Journey of Lean Manufacturing in the Pharmaceutical Industry
- The Drive Behind Lean Manufacturing Implementation
- The Right Sequence for Lean Manufacturing Implementation
- The Role of Interim Monitors in Divestitures
- The Smart Road to Pharmaceutical Consulting
- Transforming the Traditional Approach with Lean Manufacturing Techniques
