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EAS GMP Compliance Seminar

November 10 @ 12:00 pm - 4:00 pm EST

EAS GMP Compliance Seminar

cGMPs – Important Considerations of HPUS and CFR

Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections, the industry has work to do.

Learn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR).

What You'll Learn:

  • An overview and examples of inspection enforcement.
  • Requirements for registration, drug listing, and mandatory updates.
  • How to design an effective Adverse Events Reporting program.
  • Techniques and practices to provide compliance with manufacturing, packaging, holding, and distribution regulations.

OPENING KEYNOTE

Richard (Rik) Lostritto, PhD
Associate Director for Science
Office of Policy for Pharmaceutical Quality (OPPQ)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)

Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees.

Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy, Biopharmaceutics Lead, CMC Division Director (oncology, hematology, cardio-renal, neurology, and psychiatric drug products), Team Leader (pulmonary, allergy, and oncology drug products), and Review Chemist in several therapeutic areas. Prior to joining FDA, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy.

PRESENTERS

Bryan J. Coleman
Senior Director for Pharmaceutical & Medical Device Consulting Services
EAS Consulting Group, LLC

Bryan Coleman has 30 years of experience in FDA Investigations, pharmaceuticals, and tobacco quality and compliance. Prior to joining EAS, he held various management responsibilities for regulatory compliance, multi-site quality assurance/control operations, and FDA inspections management as a Senior Manager at Altria Client Services, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical, device, dietary supplement, and tobacco operations in both development and production environments. In addition to his civilian roles, Mr. Coleman is a retired Colonel (Combat Engineer, Army National Guard) who held various command and staff assignments, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations.

Robert Fish
Independent Advisor, Quality and Compliance

Robert Fish spent 33 years with FDA, the last six years of which as Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert, speaking at international events on FDA inspections and GMPs.

Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years.

WHEN

Wednesday, November 10, 2021

12:00 - 4:00 p.m. EST

WHERE

Zoom Webinar

PRICE

$249 per attendee

AAHP Members will receive a $50 rebate following the event.

For questions, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com)

Who Should Attend?

This seminar is a must-attend for domestic and foreign firms who manufacture, label, pack, or hold homeopathic drug products for sale in the United States.

  • Quality Staff
  • Legal & Regulatory Staff
  • Product Leads
  • Product R&D Staff
  • Company Leaders (President/CEO)
  • And those similarly responsible at your contract manufacturer

ABOUT EAS CONSULTING GROUP, LLC

EAS Consulting Group
1700 Diagonal Road, Suite 750
Alexandria, VA 22314

EAS Consulting Group, as part of the Certified Group of companies, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries.

EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory and quality compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.

The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies, (certified-laboratories.com), has created a leading, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs.

From regulatory strategy, auditing, training, FDA inspection preparation, 483 & Warning letter remediation, quality system implementation, labeling compliance, preparation of technical submissions such as GRAS, Food Additive Petitions, DMFs, NDIs, 510(k)s and more; to FSMA compliance, expert witness services and due diligence assessments, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com.

Details

Date:
November 10
Time:
12:00 pm - 4:00 pm EST
Event Category: