Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities are also crucial for compliance with regulatory agency requirements.
Still, their importance is often underestimated, especially in the planning phases, which leads to unnecessary increases in cycle time, costly errors, delays in product availability, or product recalls due to noncompliance.
WHY SHOULD YOU ATTEND?
Understanding the packaging and labeling process in the larger product development process will provide you an advantage in achieving success.
AREA COVERED
- Regulatory Agency Requirements
- SOPs and Change Control considerations related to packaging
- Packaging and Labeling Interactions
- Creation of the Package
- Codes
- Packaging Errors
- Labeling Errors
- Supply Chain Issues
- Special Considerations (e.g. Product Launches, Clinical vs. Commercial packaging)
LEARNING OBJECTIVES
- After completing this course, you’ll be able to:
- Articulate Packaging and Labeling’s role in product development
- Ensure adherence to regulatory agency requirements
- Anticipate potential obstacles in marketing, medical affairs, regulatory, legal or quality assurance
WHO WILL BENEFIT?
- Operations Departments
- Regulatory Affairs Departments
- Labeling and Packaging Departments
- Quality Assurance Departments
- Production Control Departments
- Packaging Technology Departments
- Labeling Coordination Departments
- Package Engineering Departments
- Packaging Operations Departments
- Project Management
- Sales and Marketing Departments
Understanding the packaging and labeling process in the larger product development process will provide you an advantage in achieving success.
- Regulatory Agency Requirements
- SOPs and Change Control considerations related to packaging
- Packaging and Labeling Interactions
- Creation of the Package
- Codes
- Packaging Errors
- Labeling Errors
- Supply Chain Issues
- Special Considerations (e.g. Product Launches, Clinical vs. Commercial packaging)
- After completing this course, you’ll be able to:
- Articulate Packaging and Labeling’s role in product development
- Ensure adherence to regulatory agency requirements
- Anticipate potential obstacles in marketing, medical affairs, regulatory, legal or quality assurance
- Operations Departments
- Regulatory Affairs Departments
- Labeling and Packaging Departments
- Quality Assurance Departments
- Production Control Departments
- Packaging Technology Departments
- Labeling Coordination Departments
- Package Engineering Departments
- Packaging Operations Departments
- Project Management
- Sales and Marketing Departments
Speaker Profile
Michael Esposito has over 30 years’ experience in the pharmaceutical industry and 17 years’ experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson's Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree workplan for Johnson & Johnson Consumer Healthcare and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence and …
Upcoming Webinars
California Meal and Rest Breaks: What You Dont Know Can Cos…
Responding to EEOC Discrimination Charges-What's Your Busin…
Implementing an Effective Human Error Reduction Program
Conflict Resolution - Prevent, De-escalate, Resolve
When Employees Travel: Wage and Expense Rules Employers Mus…
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Female to Female Hostility @Workplace: All you Need to Know
Form 1099-MISC and 1099-NEC Compliance Update 2024
Validation Statistics for Non-Statisticians
The Totally Organized Professional Is All About Outcomes
Why EBITDA Doesn't Spell Cash Flow and What Does
GAMP5, Second Edition and Alignment with Computer Software …
Project Management for Non-Project Managers - Scheduling yo…
Sunshine Act Reporting - Clarification for Clinical Research
Understanding the Math of HR… So You Can Show How HR Impact…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
How to Address ISO's New Climate Change Requirements
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
How To Conduct An Internal Harassment And Bullying Investig…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Managing Toxic & Other Employees Who Have Attitude Issues
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Do's and Don'ts of Giving Effective Feedback for Performanc…
Onboarding New Hires: Leverage the Potential of Artificial …
Project Management for HR, Administrative Professionals, an…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Using Behavior Based Interviewing for Finding the Best Matc…
How to Document Employee Discussions and Why it is Important
Stressed Out: How to Handle Conflict, Difficult People and …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Best Practices for Working With Vendors and Suppliers
Understanding the Artificial Intelligence Landscape
Marketing to Medicare or Medicaid Beneficiaries - What You …
Accounting For Non Accountants : Debit, Credits And Financi…
Principles & Practices for the Cybersecurity of Legacy Medi…
Independent Contractor vs. Employee New Rule Issued by The …
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Kicking your Employee Retention Efforts into Overdrive: Sta…