Training
Deep Dive into Pharma Training Courses
Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.
- Real World Practice: Courses present exercises that use current problems and situations common to the industry.
- Experienced Instructors: Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
- Global Training to Fit Your Needs: With eLearning
Commissioning and Qualification
19 - 20 Oct 2023
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
Instructor
GAMP® Basic Principles
19 - 20 Oct 2023
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
This classroom course has been updated to include the new revised GAMP® 5 Second Edition.
GAMP® Data Integrity 21 CFR Part 11
19 - 20 Oct 2023
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
Winnie Cappucci
Retired
Location
Mandalay Bay Resort
3950 S Las Vegas Blvd.
Las Vegas, NV 89119, USA
Hotel & Reservations: +1 877-632-7700
ISPE Membership Benefits
Become a member today
Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.
Benefits include:
- Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
- Member-only discounts on Guidance Documents, Conferences, and Training
- Pharmaceutical Engineering® magazine
- Communities of Practice access to pharma professionals in specific topics from around the world
- And more