Pharmaceutical
Best Practice for Complaint Handling to Assure Customer Retention
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved i..
Best Practices for a Compliant, Lean Supplier Management Program
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meet all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that yo..
Best Practices for Implementing an Effective Cleaning Validation (using principles of upcoming ASTM E3106)
This webinar discusses the implementation of Cleaning Validation programs based on global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. What makes this webinar special and unique is a very rare glimpse into upcoming ASTM E3106 for Cleaning Validation. This is a Risk-Based Science-Based Lifecycle approach guidance document that was fully v..
Best Practices For Investigating Deviations
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, a release of the sub-standard product, or product recall. Furthermore, costly and time-consum..
Best Practices for Managing an FDA Inspection
Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your qu..
Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach
This webinar will highlight difficulties in obtaining relevant and useful dissolution results based on current practices. This will be followed by the description of principles of drug dissolution testing leading to a simple and common set of experimental conditions reflecting a bio-relevant method. The discussion will be presented describing that the suggested bio-relevant method would become a QC method a..
Building a Compliant Laboratory – From Foundation to Business Excellence
Compliance in laboratory settings has been a topic for the FDA and other regulators for decades. With the increased focus on data integrity and continued focus on laboratory investigations, it is critical more than ever to ensure you have designed your laboratory operations system to meet the compliance needs of your business. In this presentation, I will define compliance, provide a translation of regulati..
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Analysis of investigation reports reveals that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA's that are developed from these, retraining and rewrite of SOP is top the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA's a..
Drug or Cosmetic? Promoting Health Benefits in Personal Care Products
FDA has a history of avoiding discussion of popular issues and leaving the course of history to the imagination of the industry to push the boundaries of regulatory compliance. The unwillingness by FDA to address issues like “natural”, “probiotic”, “CBD” and other popular issues, creates an opportunity to add market potential, but it also creates hazards to avoid for FDA regulated products. Assuming that di..
EU Medical Devices Regulation: CE Mark Expiration and the EU Refusal of Your Exports
FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between the FDA and the EUincludepremarket authorization (CE Mark), complaint investigations, postmarket surveillance, and reports. The EU’s new Medical Devices Regulation (MDR) incorporates more rigorous regulatory requirements for those areas and in some cases outpaces the FDA’s requirements. The FDA..
Extractables and Leacheables in Drug Development
Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies identify potential leachables and therefore assess and mitigate the above risks based on the dosage forms and the administration route. When safety concerns are detected, approaches for the toxicological evaluation of extractable and leachable have been developed and applied by pharm..
From Training to Human Reliability In Manufacturing
Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain a status of a high performing organization manufacturing sites are implementing strategies and practices like operational excellence and performance reliability. To achieve this goal, innovative approaches to traditional processes need to take place. This webinar..
Fundamentals of Good Manufacturing Practices (GMP) - Developing a Compliance Mindset
A discussion of the basic principles and requirements for Good Manufacturing Practices. The presentation provides a brief history and basis for the existence of GMPs, a discussion of what they cover, and examples of real-life situations along with a discussion of possible responses and the reasons one or more responses may be appropriate or not.Learning ObjectivesFundamental requirements of Good Manufacturi..
Horizon Planning on Emerging Issues on Prop 65
The Food Industry has also been subject to Prop 65 legal battles on a host of products from French fries, chocolate, coffee, bakery products, candy and baby food that may now require warning labels or other actions to mitigate safety concerns for the public. This course will provide an overview of how to navigate Prop 65 with a Preventative Control Program approach. Highlights will include Preventative Cont..
How Successfully Apply for a Breakthrough Therapy Designation
The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the FDA as it helps get the product to market much faster than any other expedited approval pathway. Once a drug is successful in getting the BTD, the non-clinical and clinical requirements for market approval are significantly reduced. The applicants can request special meetings with FDA to discuss the developme..