Drug Good Manufacturing Practices (GMP) Compliance Seminar
The GMPs dictated in 21 CFR 210 and 211 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters to the industry for a failure to comply with even the basic tenets of the regulation. In light of increased FDA oversight, a thorough review of industry rules for Good Manufacturing Practices (GMP) is warranted.
In these unprecedented times, the pharmaceutical industry is playing an essential role for the U.S. consumer. Never before have more questions been raised regarding Good Manufacturing Practices (GMPs), so we are offering our Drug Good Manufacturing Practices (GMP) Compliance Seminar course virtually.
GMPs, dictated in 21 CFR 210, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Drugs and 21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, have been in place for over a decade. Even with the Food and Drug Administration’s (FDA) efforts to ensure consistent manufacturing to established product specifications, industry confusion with the basic tenets of the regulation result in numerous FDA observations and Warning Letters. A thorough understanding of 21 CFR 210 and 21 CFR 211, as well as other statutory requirements is critical for compliance and safety for the consumer, both of which are required for the success of a company.
EAS Consulting Group Drug GMP Seminar helps firms prepare for FDA enforcement by facilitating an understanding of compliance requirements for responsibilities of domestic and foreign firms who manufacture, label, pack or hold pharmaceuticals for sale in the United States, including those involved with the testing, quality control and distribution of drugs.
Instructed by two cGMP experts with 30+ years combined industry experience this intensive training program will help your firm stay on top of cGMP requirements.
Who Should Attend?
- Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing, labeling, packaging, storing and distribution of drugs.
- Consultants, auditors, attorneys and others interested in learning about the requirements of the new drug GMPs and how they should be applied.
At the Drug GMP Seminar, You Will
- Learn all of the requirements of 21 CFR 210 and 21 CFR 211, and other applicable statutory requirements.
- Receive detailed practical guidance on how to apply these requirements at your facility.
- Get coaching on how to prepare for an FDA inspection and avoid receiving a List of Objectionable Inspection Observations (Form FDA 483).
- Be given an opportunity to demonstrate your understanding of GMPs in group work sessions.
Instructors
Lisa El-Shall
Senior Director for Pharmaceutical and Device Consulting Services
Lisa El-Shall has a B.S. in Chemistry from the University of North Carolina at Chapel Hill and a M.S. from the University of California, Los Angeles in Biochemistry. She has extensive experience in a Consumer Healthcare organization in both Research and Development and Quality and has held leadership positions in the analytical laboratory and quality. For the past 11 years she led the Research and Development Quality group at Pfizer and GSK with global responsibility for areas including development, clinical supply production/release, clinical study oversight, and business development quality. She has proven ability in establishment, implementation, and maintenance of fit for purpose standards, systems, and Regulatory Inspection compliance.
Jeb Hunter
Senior Regulatory Consultant
Jeb S. Hunter holds a BS in Microbiology from Clemson University and has spent his career in Quality, starting in a microbiology and chemistry laboratory setting and moving into auditing and managing Quality Management Systems. Jeb has experiences in the Pharmaceutical, Medical Device, Dietary Supplement, and Food/Tobacco industries. He is a highly capable team auditor and Lead Auditor across auditing platforms with audits conducted against a host of regulatory standards both domestic and international.
New Dates to be Announced
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Discounts
Federal and State Employees may be eligible for a 50% discount. Contact Jessica Lloyd for more details.
Two or more employees from the same firm will receive a 10% discount, auto applied in cart within the same transaction.
* Only one discount code per transaction
Cancellation Policy
EAS reserves the right to cancel the seminar if minimum participation has not been met two weeks prior to the start of the seminar. All registrations will be refunded in full.
Cancellations will be refunded minus a $95 processing fee up to two weeks prior to the start date of the seminar. After this date, no refunds will be given.
Terms and Conditions
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On-line Training
The EAS Consulting Group Drug GMP Seminar will be conducted virtually through Zoom. A link will be provided to each participant. To ensure an understanding with the instructional material, live student attendance and active participation in discussions via webcam is required. Each attendee will receive the entire presentation and a Pocket Guide in advance of the course.
Virtual Seminar Dates and Times
The virtual seminar will take place from 11:00am – 4:00pm eastern. Please verify your schedule prior to registration. Attendance at each seminar date is expected.
In-House Seminar
EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost-effective alternative to train your employees. It also allows the program to be tailored to your particular needs. Contact us for a price quote. (571) 447-5500.
For More Information or Questions
Contact Jessica Lloyd at (571) 447-5508 or trainings@easconsultinggroup.com
Training Agenda
Drug GMP Seminar
Day 1 – (11am – 4pm)
- Introduction
- FDA Authority and Enforcement and Current Good Manufacturing Practices (cGMP) Overview
- History of the GMPs
- Overview of 21 CFR Part 210 and Definitions and the Subparts of Part 211
- Subpart B: Organization and Personnel
- Subpart C: Buildings and Facilities
- Subpart D: Equipment
- Work Session #1
Day 2 – (11am – 4pm)
- Subpart E: Control of Components and Drug Product Containers and Closures
- Subpart F: Production and Process Controls
- Subpart G: Packaging and Labeling Control
- Work Session #2
Day 3 – (11am – 4pm)
- Subpart H: Holding and Distribution
- Subparts I: Laboratory Controls
- Subpart J: Records and Reports
- Subpart K: Returned and Salvaged Drug Products
- Work Session #3
Day 4 – (11am – 4pm)
- Quality Management System and Training
- Quality Agreements
- Audit programs
- Managing FDA Inspections
- Work Session #4
- Exam